KENILWORTH, N.J.--(BUSINESS WIRE)--Sep 2, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that new data from its broad and diverse oncology development program will be presented at the European Society for Medical Oncology (ESMO) Virtual Congress 2020 from Sept. 1921. Data spanning more than 15 types of cancer will be presented at the congress, with new findings from Mercks portfolio of established medicines including KEYTRUDA, Mercks anti-PD-1 therapy; LENVIMA (lenvatinib, in collaboration with Eisai); and LYNPARZA (in collaboration with AstraZeneca). Pivotal Phase 3 data evaluating KEYTRUDA in combination with chemotherapy for the first-line treatment of patients with locally advanced or metastatic esophageal cancer from the KEYNOTE-590 trial (Abstract #LBA8) and LYNPARZA in patients with metastatic castration-resistant prostate cancer (mCRPC) from the PROfound trial (Abstract #610O) were selected for inclusion in ESMO Presidential Symposium sessions. Additionally, new findings will be shared for three of Mercks novel investigational candidates: vibostolimab (MK-7684), an anti-TIGIT antibody; MK-4830, an antibody targeting ILT4; and MK-6482, an oral HIF-2 inhibitor.

At Merck, we are focused on further improving long-term outcomes for more patients living with cancer, and this commitment is reflected in the breadth and diversity of our oncology research program, said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. At the ESMO Virtual Congress 2020, we look forward to sharing important new results including survival data for KEYTRUDA in esophageal cancer and long-term findings in lung cancer, melanoma, and head and neck cancer, as well as research from our expansive pipeline.

Key data from Mercks portfolio and pipeline to be presented at ESMO include:

KEYTRUDA

KEYTRUDA Plus LENVIMA

LYNPARZA

Pipeline

Merck Investor Event

Merck will hold a virtual investor event in conjunction with the ESMO Virtual Congress 2020 on Tuesday, Sept. 22 from 89 a.m. E.T. Details will be provided at a date closer to the event at https://www.merck.com/investor-relations.

Details on Abstracts Listed Above and Additional Key Abstracts for Merck

KEYTRUDA

Classical Hodgkin Lymphoma

Colorectal Cancer

Diffuse Large B-Cell Lymphoma

Esophageal Cancer

Head and Neck Cancer

Lung Cancer

Melanoma

Sarcoma

Solid Tumors

KEYTRUDA Plus LENVIMA (in collaboration with Eisai)

Lung Cancer

Melanoma

Renal Cell Carcinoma

Solid Tumors

LYNPARZA (in collaboration with AstraZeneca)

Ovarian Cancer

Prostate Cancer

Vibostolimab

Lung Cancer

MK-4830

Solid Tumors

MK-6482

Von-Hippel Lindau Disease

About KEYTRUDA (pembrolizumab) Injection, 100 mg

KEYTRUDA is an anti-PD-1 therapy that works by increasing the ability of the bodys immune system to help detect and fight tumor cells. KEYTRUDA is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.

Merck has the industrys largest immuno-oncology clinical research program. There are currently more than 1,200 trials studying KEYTRUDA across a wide variety of cancers and treatment settings. The KEYTRUDA clinical program seeks to understand the role of KEYTRUDA across cancers and the factors that may predict a patient's likelihood of benefitting from treatment with KEYTRUDA, including exploring several different biomarkers.

Selected KEYTRUDA (pembrolizumab) Indications

Melanoma

KEYTRUDA is indicated for the treatment of patients with unresectable or metastatic melanoma.

KEYTRUDA is indicated for the adjuvant treatment of patients with melanoma with involvement of lymph node(s) following complete resection.

Non-Small Cell Lung Cancer

KEYTRUDA, in combination with pemetrexed and platinum chemotherapy, is indicated for the first-line treatment of patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), with no EGFR or ALK genomic tumor aberrations.

KEYTRUDA, in combination with carboplatin and either paclitaxel or paclitaxel protein-bound, is indicated for the first-line treatment of patients with metastatic squamous NSCLC.

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with NSCLC expressing PD-L1 [tumor proportion score (TPS) 1%] as determined by an FDA-approved test, with no EGFR or ALK genomic tumor aberrations, and is stage III where patients are not candidates for surgical resection or definitive chemoradiation, or metastatic.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with metastatic NSCLC whose tumors express PD-L1 (TPS 1%) as determined by an FDA-approved test, with disease progression on or after platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumor aberrations should have disease progression on FDA-approved therapy for these aberrations prior to receiving KEYTRUDA.

Small Cell Lung Cancer

KEYTRUDA is indicated for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Head and Neck Squamous Cell Cancer

KEYTRUDA, in combination with platinum and fluorouracil (FU), is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC).

KEYTRUDA, as a single agent, is indicated for the first-line treatment of patients with metastatic or with unresectable, recurrent HNSCC whose tumors express PD-L1 [combined positive score (CPS) 1] as determined by an FDA-approved test.

KEYTRUDA, as a single agent, is indicated for the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.

Classical Hodgkin Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or who have relapsed after 3 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Primary Mediastinal Large B-Cell Lymphoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with refractory primary mediastinal large B-cell lymphoma (PMBCL), or who have relapsed after 2 or more prior lines of therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. KEYTRUDA is not recommended for treatment of patients with PMBCL who require urgent cytoreductive therapy.

Urothelial Carcinoma

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who are not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 [combined positive score (CPS) 10], as determined by an FDA-approved test, or in patients who are not eligible for any platinum-containing chemotherapy regardless of PD-L1 status. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

KEYTRUDA is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.

KEYTRUDA is indicated for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy.

Microsatellite Instability-High or Mismatch Repair Deficient Cancer

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR)

This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with MSI-H central nervous system cancers have not been established.

Microsatellite Instability-High or Mismatch Repair Deficient Colorectal Cancer

KEYTRUDA is indicated for the first-line treatment of patients with unresectable or metastatic MSI-H or dMMR colorectal cancer (CRC).

Gastric Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test, with disease progression on or after two or more prior lines of therapy including fluoropyrimidine- and platinum-containing chemotherapy and if appropriate, HER2/neu-targeted therapy. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Esophageal Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent locally advanced or metastatic squamous cell carcinoma of the esophagus whose tumors express PD-L1 (CPS 10) as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy.

Cervical Cancer

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy whose tumors express PD-L1 (CPS 1) as determined by an FDA-approved test. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Hepatocellular Carcinoma

KEYTRUDA is indicated for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merkel Cell Carcinoma

KEYTRUDA is indicated for the treatment of adult and pediatric patients with recurrent locally advanced or metastatic Merkel cell carcinoma (MCC). This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Renal Cell Carcinoma

KEYTRUDA, in combination with axitinib, is indicated for the first-line treatment of patients with advanced renal cell carcinoma (RCC).

Endometrial Carcinoma

KEYTRUDA, in combination with LENVIMA, is indicated for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR, who have disease progression following prior systemic therapy and are not candidates for curative surgery or radiation. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trial.

Tumor Mutational Burden-High

KEYTRUDA is indicated for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB-H) [10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment options. This indication is approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials. The safety and effectiveness of KEYTRUDA in pediatric patients with TMB-H central nervous system cancers have not been established.

Cutaneous Squamous Cell Carcinoma

KEYTRUDA is indicated for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.

Selected Important Safety Information for KEYTRUDA

Immune-Mediated Pneumonitis

KEYTRUDA can cause immune-mediated pneumonitis, including fatal cases. Pneumonitis occurred in 3.4% (94/2799) of patients with various cancers receiving KEYTRUDA, including Grade 1 (0.8%), 2 (1.3%), 3 (0.9%), 4 (0.3%), and 5 (0.1%). Pneumonitis occurred in 8.2% (65/790) of NSCLC patients receiving KEYTRUDA as a single agent, including Grades 3-4 in 3.2% of patients, and occurred more frequently in patients with a history of prior thoracic radiation (17%) compared to those without (7.7%). Pneumonitis occurred in 6% (18/300) of HNSCC patients receiving KEYTRUDA as a single agent, including Grades 3-5 in 1.6% of patients, and occurred in 5.4% (15/276) of patients receiving KEYTRUDA in combination with platinum and FU as first-line therapy for advanced disease, including Grades 3-5 in 1.5% of patients.

Monitor patients for signs and symptoms of pneumonitis. Evaluate suspected pneumonitis with radiographic imaging. Administer corticosteroids for Grade 2 or greater pneumonitis. Withhold KEYTRUDA for Grade 2; permanently discontinue KEYTRUDA for Grade 3 or 4 or recurrent Grade 2 pneumonitis.

Immune-Mediated Colitis

KEYTRUDA can cause immune-mediated colitis. Colitis occurred in 1.7% (48/2799) of patients receiving KEYTRUDA, including Grade 2 (0.4%), 3 (1.1%), and 4 (<0.1%). Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 or greater colitis. Withhold KEYTRUDA for Grade 2 or 3; permanently discontinue KEYTRUDA for Grade 4 colitis.

Immune-Mediated Hepatitis (KEYTRUDA) and Hepatotoxicity (KEYTRUDA in Combination With Axitinib)

Immune-Mediated Hepatitis

KEYTRUDA can cause immune-mediated hepatitis. Hepatitis occurred in 0.7% (19/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.4%), and 4 (<0.1%). Monitor patients for changes in liver function. Administer corticosteroids for Grade 2 or greater hepatitis and, based on severity of liver enzyme elevations, withhold or discontinue KEYTRUDA.

Hepatotoxicity in Combination With Axitinib

KEYTRUDA in combination with axitinib can cause hepatic toxicity with higher than expected frequencies of Grades 3 and 4 ALT and AST elevations compared to KEYTRUDA alone. With the combination of KEYTRUDA and axitinib, Grades 3 and 4 increased ALT (20%) and increased AST (13%) were seen. Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes as compared to when the drugs are administered as single agents. For elevated liver enzymes, interrupt KEYTRUDA and axitinib, and consider administering corticosteroids as needed.

Immune-Mediated Endocrinopathies

KEYTRUDA can cause adrenal insufficiency (primary and secondary), hypophysitis, thyroid disorders, and type 1 diabetes mellitus. Adrenal insufficiency occurred in 0.8% (22/2799) of patients, including Grade 2 (0.3%), 3 (0.3%), and 4 (<0.1%). Hypophysitis occurred in 0.6% (17/2799) of patients, including Grade 2 (0.2%), 3 (0.3%), and 4 (<0.1%). Hypothyroidism occurred in 8.5% (237/2799) of patients, including Grade 2 (6.2%) and 3 (0.1%). The incidence of new or worsening hypothyroidism was higher in 1185 patients with HNSCC (16%) receiving KEYTRUDA, as a single agent or in combination with platinum and FU, including Grade 3 (0.3%) hypothyroidism. Hyperthyroidism occurred in 3.4% (96/2799) of patients, including Grade 2 (0.8%) and 3 (0.1%), and thyroiditis occurred in 0.6% (16/2799) of patients, including Grade 2 (0.3%). Type 1 diabetes mellitus, including diabetic ketoacidosis, occurred in 0.2% (6/2799) of patients.

Monitor patients for signs and symptoms of adrenal insufficiency, hypophysitis (including hypopituitarism), thyroid function (prior to and periodically during treatment), and hyperglycemia. For adrenal insufficiency or hypophysitis, administer corticosteroids and hormone replacement as clinically indicated. Withhold KEYTRUDA for Grade 2 adrenal insufficiency or hypophysitis and withhold or discontinue KEYTRUDA for Grade 3 or Grade 4 adrenal insufficiency or hypophysitis. Administer hormone replacement for hypothyroidism and manage hyperthyroidism with thionamides and beta-blockers as appropriate. Withhold or discontinue KEYTRUDA for Grade 3 or 4 hyperthyroidism. Administer insulin for type 1 diabetes, and withhold KEYTRUDA and administer antihyperglycemics in patients with severe hyperglycemia.

Immune-Mediated Nephritis and Renal Dysfunction

KEYTRUDA can cause immune-mediated nephritis. Nephritis occurred in 0.3% (9/2799) of patients receiving KEYTRUDA, including Grade 2 (0.1%), 3 (0.1%), and 4 (<0.1%) nephritis. Nephritis occurred in 1.7% (7/405) of patients receiving KEYTRUDA in combination with pemetrexed and platinum chemotherapy. Monitor patients for changes in renal function. Administer corticosteroids for Grade 2 or greater nephritis. Withhold KEYTRUDA for Grade 2; permanently discontinue for Grade 3 or 4 nephritis.

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New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck's Commitment to Advancing Cancer Research and Care - The Baytown Sun

Cardiac Stem Cells Comments Off on New Scientific Data at the ESMO Virtual Congress 2020 Reflect Merck’s Commitment to Advancing Cancer Research and Care – The Baytown Sun | September 3rd, 2020

AMSBIO has announced new additions and certifications for its range of clinical grade, chemically defined cryopreservation excipient solutions STEM-CELLBANKER and HSC-BANKER.

STEM-CELLBANKER DMSO Free GMP grade is a new chemically defined freezing solution that does not contain DMSO as an anti-freezing agent. It was developed for customers who prefer not to use DMSO-containing cryopreservation solution due to the intended application of the samples. STEM-CELLBANKER DMSO Free GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines.

STEM-CELLBANKER is a chemically defined freezing media optimized for stem cells and iPS cells storage, as well as fragile primary cells. Published data supports its ability to cryopreserve organoids and tissues to allow the recovery of viable cells. STEM-CELLBANKER GMP grade is manufactured in compliance with JPN, EU, US, and PIC/S GMP guidelines. Free from animal derived components this popular cryopreservation medium contains only chemically defined USP, EP and JP grade ingredients. Available in both DMSO containing and DMSO-Free formulations, STEM-CELLBANKER is an optimal freezing solution for basic research and is finding widespread use in the clinical application of cell therapy products.

Manufactured to be completely free of serum and animal derived components, HSC-BANKER contains only European or US Pharmacopoeia graded ingredients making it suitable for storage of hematopoietic stem cells developed for cell therapy applications.

Recently the master files of HSC-BANKER were accepted by the Center for Biologics Evaluation and Research (CBER) within the US FDA (Food and Drug Administration). Master files are submissions to the FDA used to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products. Beneficially they allow researchers to reference material without disclosing Master file contents to those parties.

HSC-BANKER is supplied ready-to-use and requires no special devices, such as a controlled rate freezer, in order to achieve consistently high viabilities following resuscitation from cryopreservation, even over extended long-term storage. HSC-BANKER significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability after freeze-thaw. Evaluated for endotoxins, pH, osmolarity and mycoplasma contaminants to ensure GMP equivalent quality. HSC-BANKER is part of the CELLBANKER range of cryopreservation media for cells, organoids and tissues.

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Optimized Freezing Solutions for Clinical Application of Cell Therapy Products - Technology Networks

IPS Cell Therapy Comments Off on Optimized Freezing Solutions for Clinical Application of Cell Therapy Products – Technology Networks | September 3rd, 2020

HACKENSACK, N.J., Sept. 1, 2020 /PRNewswire/ --Royal Biologics, an ortho-biologics company specializing in the research and advancement of autologous and live cellular solutions, today announced the completed acquisition of FIBRINET, from Vertical Spine LLC. The acquisition comes as part of Royal Biologics' strategic initiative to add novel technologies to its growing portfolio of autologous and live cellular solutions to support orthopedic and spinal fusion.

The FIBRINET system utilizes a patient's own autologous blood to create a platelet-rich fibrin matrix/membrane (PRFM). During this process, a patient's autologous platelets are harvested first through centrifugation and then combined with a proprietary solution to solidify into a fibrin clot/membrane. PRFM can be used to help augment spinal fusions and provide surgeons a new and novel biologic option. FIBRINET is the first commercialized system that utilizes a non-thrombin solution to create a reproducible platelet-rich fibrin matrix. The use of its proprietary solution to solidify a fibrin membrane provides the unique advantage of creating a biologic reservoir of growth factors and stem cells that can be held and used at the point of care for spinal fusion.

"We are extremely excited to add FIBRINET to our growing portfolio of autologous and live cellular therapies," says Salvatore Leo, Royal Biologics Chief Executive Officer. "FIBRINET'S technology now allows surgeons to harvest a patient's autologous cells and create a unique platelet-rich fibrin membrane-scaffold to be used at the point of care in most spinal fusion procedures. When added to our current product portfolio of autologous and live cellular therapies, we feel that providing each patient an opportunity to harvest their own unique cells for treatment is a superior option in many surgical settings."

FIBRINET has shown promising results and has been adopted into major orthopedic institutions in the United States. Hospitals such as Hospital for Special Surgery, Mount Sinai, NY Presbyterian and Connecticut's Orthopaedic Institute have all adopted FIBRINET into their spine services portfolio of approved products for use.

In a recent European Spine Journalstudy, at a one-year follow-up, FIBRINET demonstrated over a 92.4% radiographic fusion, and there was a significant improvement recorded in VAS scores for both back and leg pain. Compared to baseline figures, the number of patients using opioid analgesics at 12 months decreased by 38%. While the majority (31/50) of patients that participated in the study were retired, 68% of the employed patients were able to return to work.1

"FIBRINET presents itself as a low-cost option to obtain premium, high-quality viable cells from the patient for each fusion procedure," comments Dr. James Yue, Co-Chief and Orthopedic Spine Surgeon at Midstate Medical Center. "During this pandemic, a time when patients are having difficulty receiving operations in major hospital systems, the transition of procedures to ambulatory surgery centers has become even more desired and essential. FIBRINET's low-cost bundle provides surgeons the ability to offer a live viable cell product, point of care in a streamlined and safe environment for spinal fusion."

As part of a national re-launch plan for FIBRINET, Royal Biologics has just launched a new 3D animated moviethat demonstrates the unique features and benefits of FIBRINET's technology. "We wanted to show surgeons, distributors and our peers a new and creative take on Autologous & Live Cellular therapy," comments Leo. "With the recent pandemic and industry environment, we felt it was necessary to help create a unique viewing experience of the FIBRINET system."

FIBRINET comes after two other recent product launches from Royal Biologics in Q1 of 2020. Magnus, a live viable cellular allograft, and Cryo-Cord, a live cellular umbilical cord, were launched in the first quarter of 2020. Both products focus on providing live cellular therapies without the use of traditional toxic cyro-protectants. Both products are new, novel approaches to preserving live cells in a cryo-protected format.

Royal Biologic's FIBRINET is available for U.S. national distribution. Please contact [emailprotected] for more information.

1"Singlecenter, consecutive series study of the use of a novel plateletrich fibrin matrix (PRFM) and betatricalcium phosphate in posterolateral lumbar fusion," European Spine Journal https://doi.org/10.1007/s00586-018-5832-5, July 16, 2018.

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Royal Biologics Announces the Acquisition of FIBRINET - PRNewswire

Spinal Cord Stem Cells Comments Off on Royal Biologics Announces the Acquisition of FIBRINET – PRNewswire | September 1st, 2020

The Plasma Therapy market research report added by Market Study Report, LLC, is an in-depth analysis of the latest trends persuading the business outlook. The report also offers a concise summary of statistics, market valuation, and profit forecast, along with elucidating paradigms of the evolving competitive environment and business strategies enforced by the behemoths of this industry.

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Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 - StartupNG

Cardiac Stem Cells Comments Off on Plasma Therapy Market Overview with Detailed Analysis, Competitive landscape, Forecast to 2025 – StartupNG | September 1st, 2020

Efforts to use regenerative medicinewhich seeks to address ailments as diverse as birth defects, traumatic injury, aging, degenerative disease, and the disorganized growth of cancerwould be greatly aided by solving one fundamental puzzle: How do cellular collectives orchestrate the building of complex, three-dimensional structures?

While genomes predictably encode the proteins present in cells, a simple molecular parts list does not tell us enough about the anatomical layout or regenerative potential of the body that the cells will work to construct. Genomes are not a blueprint for anatomy, and genome editing is fundamentally limited by the fact that its very hard to infer which genes to tweak, and how, to achieve desired complex anatomical outcomes. Similarly, stem cells generate the building blocks of organs, but the ability to organize specific cell types into a working human hand or eye has been and will be beyond the grasp of direct manipulation for a very long time.

But researchers working in the fields of synthetic morphology and regenerative biophysics are beginning to understand the rules governing the plasticity of organ growth and repair. Rather than micromanaging tasks that are too complex to implement directly at the cellular or molecular level, what if we solved the mystery of how groups of cells cooperate to construct specific multicellular bodies during embryogenesis and regeneration? Perhaps then we could figure out how to motivate cell collectives to build whatever anatomical features we want.

New approaches now allow us to target the processes that implement anatomical decision-making without genetic engineering. In January, using such tools, crafted in my lab at Tufts Universitys Allen Discovery Center and by computer scientists in Josh Bongards lab at the University of Vermont, we were able to create novel living machines, artificial bodies with morphologies and behaviors completely different from the default anatomy of the frog species (Xenopus laevis) whose cells we used. These cells rebooted their multicellularity into a new form, without genomic changes. This represents an extremely exciting sandbox in which bioengineers can play, with the aim of decoding the logic of anatomical and behavioral control, as well as understanding the plasticity of cells and the relationship of genomes to anatomies.

Deciphering how an organism puts itself together is truly an interdisciplinary undertaking.

Deciphering how an organism puts itself together is truly an interdisciplinary undertaking. Resolving the whole picture will involve understanding not only the mechanisms by which cells operate, but also elucidating the computations that cells and groups of cells carry out to orchestrate tissue and organ construction on a whole-body scale. The next generation of advances in this area of research will emerge from the flow of ideas between computer scientists and biologists. Unlocking the full potential of regenerative medicine will require biology to take the journey computer science has already taken, from focusing on the hardwarethe proteins and biochemical pathways that carry out cellular operationsto the physiological software that enables networks of cells to acquire, store, and act on information about organ and indeed whole-body geometry.

In the computer world, this transition from rewiring hardware to reprogramming the information flow by changing the inputs gave rise to the information technology revolution. This shift of perspective could transform biology, allowing scientists to achieve the still-futuristic visions of regenerative medicine. An understanding of how independent, competent agents such as cells cooperate and compete toward robust outcomes, despite noise and changing environmental conditions, would also inform engineering. Swarm robotics, Internet of Things, and even the development of general artificial intelligence will all be enriched by the ability to read out and set the anatomical states toward which cell collectives build, because they share a fundamental underlying problem: how to control the emergent outcomes of systems composed of many interacting units or individuals.

Many types of embryos can regenerate entirely if cut in half, and some species are proficient regenerators as adults. Axolotls (Ambystoma mexicanum) regenerate their limbs, eyes, spinal cords, jaws, and portions of the brain throughout life. Planarian flatworms (class Turbellaria), meanwhile, can regrow absolutely any part of their body; when the animal is cut into pieces, each piece knows exactly whats missing and regenerates to be a perfect, tiny worm.

The remarkable thing is not simply that growth begins after wounding and that various cell types are generated, but that these bodies will grow and remodel until a correct anatomy is complete, and then they stop. How does the system identify the correct target morphology, orchestrate individual cell behaviors to get there, and determine when the job is done? How does it communicate this information to control underlying cell activities?

Several years ago, my lab found that Xenopus tadpoles with their facial organs experimentally mixed up into incorrect positions still have largely normal faces once theyve matured, as the organs move and remodel through unnatural paths. Last year, a colleague at Tufts came to a similar conclusion: the Xenopus genome does not encode a hardwired set of instructions for the movements of different organs during metamorphosis from tadpole to frog, but rather encodes molecular hardware that executes a kind of error minimization loop, comparing the current anatomy to the target frog morphology and working to progressively reduce the difference between them. Once a rough spatial specification of the layout is achieved, that triggers the cessation of further remodeling.

The deep puzzle of how competent agents such as cells work together to pursue goals such as building, remodeling, or repairing a complex organ to a predetermined spec is well illustrated by planaria. Despite having a mechanistic understanding of stem cell specification pathways and axial chemical gradients, scientists really dont know what determines the intricate shape and structure of the flatworms head. It is also unknown how planaria perfectly regenerate the same anatomy, even as their genomes have accrued mutations over eons of somatic inheritance. Because some species of planaria reproduce by fission and regeneration, any mutation that doesnt kill the neoblastthe adult stem cell that gives rise to cells that regenerate new tissueis propagated to the next generation. The worms incredibly messy genome shows evidence of this process, and cells in an individual planarian can have different numbers of chromosomes. Still, fragmented planaria regenerate their body shape with nearly 100 percent anatomical fidelity.

Permanent editingof the encoded target morphology without genomic editing reveals a new kind of epigenetics.

So how do cell groups encode the patterns they build, and how do they know to stop once a target anatomy is achieved? What would happen, for example, if neoblasts from a planarian species with a flat head were transplanted into a worm of a species with a round or triangular head that had the head amputated? Which shape would result from this heterogeneous mixture? To date, none of the high-resolution molecular genetic studies of planaria give any prediction for the results of this experiment, because so far they have all focused on the cellular hardware, not on the logic of the softwareimplemented by chemical, mechanical, and electrical signaling among cellsthat controls large-scale outcomes and enables remodeling to stop when a specific morphology has been achieved.

Understanding how cells and tissues make real-time anatomical decisions is central not only to achieving regenerative outcomes too complex for us to manage directly, but also to solving problems such as cancer. While the view of cancer as a genetic disorder still largely drives clinical approaches, recent literature supports a view of cancer as cells simply not being able to receive the physiological signals that maintain the normally tight controls of anatomical homeostasis. Cut off from these patterning cues, individual cells revert to their ancient unicellular lifestyle and treat the rest of the body as external environment, often to ruinous effect. If we understand the mechanisms that scale single-cell homeostatic setpoints into tissue- and organ-level anatomical goal states and the conditions under which the anatomical error reduction control loop breaks down, we may be able to provide stimuli to gain control of rogue cancer cells without either gene therapy or chemotherapy.

During morphogenesis, cells cooperate to reliably build anatomical structures. Many living systems remodel and regenerate tissues or organs despite considerable damagethat is, they progressively reduce deviations from specific target morphologies, and halt growth and remodeling when those morphologies are achieved. Evolution exploits three modalities to achieve such anatomical homeostasis: biochemical gradients, bioelectric circuits, and biophysical forces. These interact to enable the same large-scale form to arise despite significant perturbations.

N.R. FULLER, SAYO-ART, LLC

BIOCHEMICAL GRADIENTS

The best-known modality concerns diffusible intracellular and extracellular signaling molecules. Gene-regulatory circuits and gradients of biochemicals control cell proliferation, differentiation, and migration.

BIOELECTRIC CIRCUITS

The movement of ions across cell membranes, especially via voltage-gated ion channels and gap junctions, can establish bioelectric circuits that control large-scale resting potential patterns within and among groups of cells. These bioelectric patterns implement long-range coordination, feedback, and memory dynamics across cell fields. They underlie modular morphogenetic decision-making about organ shape and spatial layout by regulating the dynamic redistribution of morphogens and the expression of genes.

BIOMECHANICAL FORCES

Cytoskeletal, adhesion, and motor proteins inside and between cells generate physical forces that in turn control cell behavior. These forces result in large-scale strain fields, which enable cell sheets to move and deform as a coherent unit, and thus execute the folds and bends that shape complex organs.

The software of life, which exploits the laws of physics and computation, is enabled by chemical, mechanical, and electrical signaling across cellular networks. While the chemical and mechanical mechanisms of morphogenesis have long been appreciated by molecular and cell biologists, the role of electrical signaling has largely been overlooked. But the same reprogrammability of neural circuits in the brain that supports learning, memory, and behavioral plasticity applies to all cells, not just neurons. Indeed, bacterial colonies can communicate via ionic currents, with recent research revealing brain-like dynamics in which information is propagated across and stored in a kind of proto-body formed by bacterial biofilms. So it should really come as no surprise that bioelectric signaling is a highly tractable component of morphological outcomes in multicellular organisms.

A few years ago, we studied the electrical dynamics that normally set the size and borders of the nascent Xenopus brain, and built a computer model of this process to shed light on how a range of various brain defects arise from disruptions to this bioelectric signaling. Our model suggested that specific modifications with mRNA or small molecules could restore the endogenous bioelectric patterns back to their correct layout. By using our computational platform to select drugs to open existing ion channels in nascent neural tissue or even a remote body tissue, we were able to prevent and even reverse brain defects caused not only by chemical teratogenscompounds that disrupt embryonic developmentbut by mutations in key neurogenesis genes.

Similarly, we used optogenetics to stimulate electrical activity in various somatic cell types totrigger regeneration of an entire tadpole tailan appendage with spinal cord, muscle, and peripheral innervationand to normalize the behavior of cancer cells in tadpoles strongly expressing human oncogenes such as KRAS mutations. We used a similar approach to trigger posterior regions, such as the gut, to build an entire frog eye. In both the eye and tail cases, the information on how exactly to build these complex structures, and where all the cells should go, did not have to be specified by the experimenter; rather, they arose from the cells themselves. Such findings reveal how ion channel mutations result in numerous human developmental channelopathies, and provide a roadmap for how they may be treated by altering the bioelectric map that tells cells what to build.

We also recently found a striking example of such reprogrammable bioelectrical software in control of regeneration in planaria. In 2011, we discovered that an endogenous electric circuit establishes a pattern of depolarization and hyperpolarization in planarian fragments that regulate the orientation of the anterior-posterior axis to be rebuilt. Last year, we discovered that this circuit controls the gene expressionneeded to build a head or tail within six hours of amputation, and by using molecules that make cell membranes permeable to certain ions to depolarize or hyperpolarize cells, we induced fragments of such worms to give rise to a symmetrical two-headed form, despite their wildtype genomes. Even more shockingly, the worms continued to generate two-headed progeny in additional rounds of cutting with no further manipulation. In further experiments, we demonstrated that briefly reducing gap junction-mediated connectivity between adjacent cells in the bioelectric network that guides regeneration led worms to regenerate head and brain shapes appropriate to other worm species whose lineages split more than 100 million years ago.

My group has developed the use of voltage-sensitive dyes to visualize the bioelectric pattern memory that guides gene expression and cell behavior toward morphogenetic outcomes. Meanwhile, my Allen Center colleagues are using synthetic artificial electric tissues made of human cells and computer models of ion channel activity to understand how electrical dynamics across groups of non-neural cells can set up the voltage patterns that control downstream gene expression, distribution of morphogen molecules, and cell behaviors to orchestrate morphogenesis.

The emerging picture in this field is that anatomical software is highly modulara key property that computer scientists exploit as subroutines and that most likely contributes in large part to biological evolvability and evolutionary plasticity. A simple bioelectric state, whether produced endogenously during development or induced by an experimenter, triggers very complex redistributions of morphogens and gene expression cascades that are needed to build various anatomies. The information stored in the bodys bioelectric circuitscan be permanently rewritten once we understand the dynamics of the biophysical circuits that make the critical morphological decisions. This permanent editing of the encoded target morphology without genomic editing reveals a new kind of epigenetics, information that is stored in a medium other than DNA sequences and chromatin.

Recent work from our group and others has demonstrated that anatomical pattern memories can be rewritten by physiological stimuli and maintained indefinitely without genomic editing. For example, the bioelectric circuit that normally determines head number and location in regenerating planaria can be triggered by brief alterations of ion channel or gap junction activity to alter the animals body plan. Due to the circuits pattern memory, the animals remain in this altered state indefinitely without further stimulation, despite their wildtype genomes. In other words, the pattern to which the cells build after damage can be changed, leading to a target morphology distinct from the genetic default.

N.R. FULLER, SAYO-ART, LLC

First, we soaked a planarian in voltage-sensitive fluorescent dye to observe the bioelectrical pattern across the entire tissue. We then cut the animal to see how this pattern changes in each fragment as it begins to regenerate.

We then applied drugs or used RNA interference to target ion channels or gap junctions in individual cells and thus change the pattern of depolarization/hyperpolarization and cellular connectivity across the whole fragment.

As a result of the disruption of the bodys bioelectric circuits, the planarian regrows with two heads instead of one, or none at all.

When we re-cut the two-headed planarian in plain water, long after the initial drug has left the tissue, the new anatomy persists in subsequent rounds of regeneration.

Cells can clearly build structures that are different from their genomic-default anatomical outcomes. But are cells universal constructors? Could they make anything if only we knew how to motivate them to do it?

The most recent advances in the new field at the intersection of developmental biology and computer science are driven by synthetic living machines known as biobots. Built from multiple interacting cell populations, these engineered machines have applications in disease modeling and drug development, and as sensors that detect and respond to biological signals. We recently tested the plasticity of cells by evolving in silico designs with specific movement and behavior capabilities and used this information to sculpt self-organized growth of aggregated Xenopus skin and muscle cells. In a novel environmentin vitro, as opposed to inside a frog embryoswarms of genetically normal cells were able to reimagine their multicellular form. With minimal sculpting post self-assembly, these cells form Xenobots with structures, movements, and other behaviors quite different from what might be expected if one simply sequenced their genome and identified them as wildtype X. laevis.

These living creations are a powerful platform to assess and model the computations that these cell swarms use to determine what to build. Such insights will help us to understand evolvability of body forms, robustness, and the true relationship between genomes and anatomy, greatly potentiating the impact of genome editing tools and making genomics more predictive for large-scale phenotypes. Moreover, testing regimes of biochemical, biomechanical, and bioelectrical stimuli in these biobots will enable the discovery of optimal stimuli for use in regenerative therapies and bioengineered organ construction. Finally, learning to program highly competent individual builders (cells) toward group-level, goal-driven behaviors (complex anatomies) will significantly advance swarm robotics and help avoid catastrophes of unintended consequences during the inevitable deployment of large numbers of artificial agents with complex behaviors.

Understanding how cells and tissues make real-time anatomical decisions is central to achieving regenerative outcomes too complex for us to manage directly.

The emerging field ofsynthetic morphology emphasizes a conceptual point that has been embraced by computer scientists but thus far resisted by biologists: the hardware-software distinction. In the 1940s, to change a computers behavior, the operator had to literally move wires aroundin other words, she had to directly alter the hardware. The information technology revolution resulted from the realization that certain kinds of hardware are reprogrammable: drastic changes in function could be made at the software level, by changing inputs, not the hardware itself.

In molecular biomedicine, we are still focused largely on manipulating the cellular hardwarethe proteins that each cell can exploit. But evolution has ensured that cellular collectives use this versatile machinery to process information flexibly and implement a wide range of large-scale body shape outcomes. This is biologys software: the memory, plasticity, and reprogrammability of morphogenetic control networks.

The coming decades will be an extremely exciting time for multidisciplinary efforts in developmental physiology, robotics, and basal cognition to understand how individual cells merge together into a collective with global goals not belonging to any individual cell. This will drive the creation of new artificial intelligence platforms based not on copying brain architectures, but on the multiscale problem-solving capacities of cells and tissues. Conversely, the insights of cognitive neurobiology and computer science will give us a completely new window on the information processing and decision-making dynamics in cellular collectives that can very effectively be targeted for transformative regenerative therapies of complex organs.

Michael Levinis the director of the Allen Discovery Center at Tufts University and Associate Faculty at Harvard Universitys Wyss Institute. Email him atmichael.levin@tufts.edu. M.L. thanks Allen Center Deputy DirectorJoshua Finkelsteinfor suggestions on the drafts of this story.

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How Groups of Cells Cooperate to Build Organs and Organisms - The Scientist

Skin Stem Cells Comments Off on How Groups of Cells Cooperate to Build Organs and Organisms – The Scientist | September 1st, 2020

During the 2020 European Society for Blood and Marrow Transplantation Annual Meeting, Rafael F. Duarte, MD, PhD, FRCP, of the Hospital Universitario Puerta de Hierro Majadahonda in Madrid, Spain, presented 2 real-world clinical cases in which the investigational monoclonal antibody narsoplimab (OMS721) demonstrated clinical benefit in patients with hematopoietic stem cell transplantation-associated thrombotic microangiopathy (HSCT-TMA).

Because the selection of patients for clinical trials has limitations, and more so, because running a trial is a hard endeavor for this difficult complication, [I wanted to share] some hands-on experience that we have had with narsoplimab outside of the trial with some case studies of patients who have been treated in a compassionate-use basis, said Duarte.

First, Duarte shared a case of a 19-year-old female who received narsoplimab following matched-sibling allogeneic HSCT to treat her B-cell acute lymphoblastic leukemia (B-ALL) in first complete remission.

At 5 months, the patient experienced late-onset acute graft-versus-host disease (GVHD) and severe HSCT-TMA with lower gastrointestinal (GI) bleeding and ischemic ulcers. While skin involvement of GVHD resolved, she received initial treatment with 1 dose of eculizumab (Soliris) due to persistent GI symptoms after steroids, mesenchymal stromal cells, and extracorporeal photopheresis. Additionally, she received 4 mg/kg of narsoplimab once or twice weekly for a total of 18 doses.

We asked for narsoplimab purely on the basis that this was a severely immunocompromised patient who had experienced complications before and who had been receiving a lot of immunosuppression for the treatment of GVHD, said Duarte. We tried to minimize immunosuppression, so we thought narsoplimab would be a good option.

According to Duarte, the patients GI bleeding and microangiopathy hemolytic anemia resolved quickly and dramatically after starting narsoplimab. Additionally, she became transfusion independent with platelet counts above 100 x 109 per liter.

At 21 months, the patient remains in complete remission (CR) of B-ALL and is devoid of signs of HSCT-TMA after discontinuing narsoplimab.

Subsequently, Duarte presented another, more complex case of a 48-year-old male with HIV and Hodgkin lymphoma who was in his third CR.

Following CCR5-32/32 HSCT, the patient experienced very early HSCT-TMA on day 0. Subsequently, he had rapid severe renal failure that required hemodialysis.

Initial treatment with calcineurin inhibitor withdrawal did not elicit any response, so he was started on narsoplimab at 4 mg/kg twice weekly on day 6. He received a total of 8 doses of narsoplimab.

The patients lactate dehydrogenase (LDH), bilirubin, and schistocyte counts improved rapidly following narsoplimab initiation. Additionally, the patient derived partial improvement of renal function and fluid management, although he required continued dialysis.

Despite this, at 31 days post-transplant, the patient had multiple secondary complications as a result of the CCR5-32/32 HSCT and experienced sudden death. The death was not thought to be related to TMA and no autopsy was granted.

We dont have a better explanation regarding what happened with this patient, unfortunately, Duarte explained. We think we are seeing that many of the patients who undergo transplant with this mutated CCR5-32/32 tend to have greater mortality and greater complications than HIV-positive patients who undergo transplant with standard [procedure].

Duarte also presented findings from the pivotal, phase 2 trial, in which narsoplimab demonstrated high rates of CRs, as well as improved laboratory and clinical markers among patients with HSCT-TMA.

Narsoplimab was previously granted a breakthrough therapy designation by the FDA for the treatment of patients with high-risk TA-TMA. In addition, the agent was granted an orphan drug designation for TA-TMA therapy and complement-mediated TMA prevention.

Findings from the single-arm, open-label phase 2 trial demonstrated a 54% CR rate in all treated patients (n = 28) with the mannan-binding lectin-associated serine protease-2 inhibitor (95% CI, 34%-72%). Additionally, patients treated per protocol recommendations (n = 23), which entailed 4 weeks or more of dosing, achieved a CR rate of 65% (95% CI, 43%-84%).

At 100 days following HSCT-TMA diagnosis, 68% of all treated patients, 83% of patients treated per protocol, and 93% of treatment responders (n = 15) were alive.

Eligible patients had to be 18 years of older at screening, which occurred during the patients first visit. Additionally, patients had to have persistent HSCT-TMA as defined by a platelet count less than 150,000 per L, evidence of microangiopathy hemolysis such as the presence of schistocytes, serum LDH greater than upper limit of normal, or haptoglobin less than the lower limit of normal, and renal dysfunction defined as doubling of serum creatinine compared with pre-transplant level. All of the following had to be present for at least 2 weeks following modification or discontinuation of calcineurin inhibitors.

Patients who had eculizumab therapy within 3 months of screening, positive direct Coombs test, or active systemic bacteria or fungal infection that required antimicrobial therapy beyond prophylactic antimicrobial therapy as a standard of care were excluded from the study.

Response-based efficacy requiring improvement in TMA laboratory markers of platelet count and LDH and improvement in clinical status, as well as safety, served as the primary end points of the trial. Secondary end points included survival and change from baseline laboratory markers.

Regarding laboratory markers, LDH had to be less than 1.5 L. For patients who had a baseline platelet count of 20,000/L, improvement was defined as a tripling of baseline platelet count more than 30,000 and freedom from platelet transfusion. For patients with a baseline platelet count of more than 20,000, improvement was defined as an increased count of least 50% and absolute count of more than 75,000, as well as freedom from platelet transfusion.

Clinical improvement was based off any of the following improvements in specific organ function. Patients could derive blood improvement defined as transfusion freedom; renal improvement defined as a reduction of creatinine of more than 40%, normalization of creatinine and more than 20% reduction of creatinine, or discontinuation of renal replacement therapy; pulmonary improvement defined as extubation and discontinuation of ventilator support, or discontinuation of non-invasive mechanical ventilation; gastrointestinal improvement defined as improvement assessed by MAGIC (Mount Sinai GVHD International Consortium) criteria; or neurological improvement defined as limited to stroke, posterior reversible encephalopathy syndrome, seizures, and weakness.

Eligible patients had an average age of 48, and 71% were male. Moreover, 96% of patients had malignant underlying disease. Regarding risk factors, 64% had GVHD, 75% had significant infection, 14% had non-infectious pulmonary complications, such as idiopathy pneumonia syndrome or diffuse alveolar hemorrhage, and 50% had neurological signs.

Moreover, the study population was defined as high risk as 93% of patients had multiple risk factors associated with poor outcome.

Regarding safety, any-grade toxicities were observed in 92.9% of patients treated with narsoplimab. The most common adverse effects (AEs) included nausea, vomiting, diarrhea, hypokalemia, neutropenia, and fever.

Additionally, 21% of patients died while on study; however, all deaths were attributed to common complications of HSCT.

Investigators concluded that similar AEs are associated with patients who undergo transplant and that narsoplimab was generally well tolerated.

These are very highly encouraging results with narsoplimab in patients with very severe TMA who are unresponsive to other treatments. These results suggest that narsoplimab may be of benefit in these severely ill, complex patients with TMA, including those in the most complex clinical scenarios, Duarte concluded.

Reference

Duarte R. MASP-2 inhibition with the investigational agent narsoplimab for the treatment of HSCT-TMA: overview of data and case discussion. Presented at: 2020 European Society for Blood and Marrow Transplantation Annual Meeting; August 30-September 2, 2020; Virtual. Session IS28-4.

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Emerging Evidence Supports the Use of Narsoplimab in HSCT-TMA - OncLive

Skin Stem Cells Comments Off on Emerging Evidence Supports the Use of Narsoplimab in HSCT-TMA – OncLive | September 1st, 2020

It was about the 3rd week into Bastions recovery from his TPLO surgery and he was already having a rough time. Bastion was a gregarious yellow Labrador who had his injured stifle about 25 days ago. Fortunately, his family elected for him to have his stifle surgically reconstructed. Initially, he had recovered well from surgery. But one day in particular, he presented to the hospital because he had a brief setback. He was limping far more severely than what would be normally expected at this stage of recovery.

The osteotomy from his surgery had not yet completely healed and he was still in the middle of his prescribed 5 weeks of exercise strict restriction. His family was trying their best but Bastion wasnt having it. He was too active at home and his humans were growing frustrated. Anti-anxiety medications had been dispensed but they were not given. Instead, his family had decided to give him CBD oil at home. When I asked why the prescribed medications had not been given, the client responded, I found CBD oil at the local farmers market and I figured it would work just as well.

Like Bastion, an increasing number of pets are receiving cannabidiol (CBD) supplements. The popularity of CBD continues to rise and many clients are incorporating CBD as part of the medication protocol for their pets, either as an adjunct or, as alternative treatment option.

Perhaps the initial interest in the benefits of CBD can be traced back to 1998, or possibly earlier, when scientists at the National Institutes of Health discovered that CBD could protect cells from oxidative stress. These findings fueled interest in the human medical field and, in large part, that appeal has been transmuted into veterinary medicine. The regard for this molecule has risen to such levels that in many homes, CBD is being used as the sole treatment option for a variety of medical conditions.

Veterinarians are becoming more fluent in the fascinating pharmacology regarding the use of this phytocannabinoid. A recent survey indicated that most veterinarians (61.5%) felt comfortable discussing the use of CBD with their colleagues, but only 45.5% felt comfortable discussing this topic with clients.1 Furthermore, veterinarians and clients in states with legalized recreational marijuana were more likely to talk about the use of CBD products to treat canine ailments than those in other states.2 Lastly, CBD was most frequently discussed as a potential treatment for pain management, anxiety and seizures.1 At first glance, the use of CBD has tangential or limited relevance in the world of veterinary surgery. However, as one takes a closer look at the putative, and proven benefits, it is clear that we are just scratching the surface of its therapeutic benefits. This article takes a brief dive into the world of CBD and its promise in the field of veterinary surgery.

Pain

Whether you perform surgery within a specialty discipline (oncology, orthopedics, neurology, soft tissue surgery, mixed animal, oral/dental, etc), or surgery is only a small part of your general practice, every veterinarian endeavors to aggressively manage pain. The first choice for pain relief among many clinicians are the medications that have been more extensively studied including, but not limited to, anti-inflammatories, gabapentinoids, opioids, local anesthetics, and other analgesics (acetaminophen, amantadine, cerenia etc). These medications or a combination thereof, have been prescribed to treat pain from orthopedic surgery, soft tissue surgery, surgical neuropathic conditions, pain from intestinal surgery, to name just a few. In the most basic schema, pain is divided into four categories: nociceptive pain (a response to damaged tissue), neuropathic pain (a response to directly-damaged sensory or spinal nerves), centralized pain (the result of pain signals being improperly amplified), and inflammatory pain.1 Cannabinoids may have a role to play in mediating all four of these types of pain states. When tissue is damaged, histamine, serotonin, TNF-alpha, IL-1-beta, IL-6, and Il -17 6, and interleukin 17 are released.2 Cannabinoids bind to the CB1 receptors and attenuate the pain signal by slowing down the release of those neurotransmitters.3 This process can take place locally or in the central nervous system.3 Cannabinoids have also been shown to inhibit the release of GABA, a well known neurotransmitter associated with pain.3 Although there is a paucity of clinical research on the use of CBD to treat postoperative pain in the veterinary medical setting, there has been heartening research conducted in humans. Indeed, National Academies of Sciences, Engineering, and Medicine concluded that there is, substantial evidence that cannabis is an effective treatment for chronic pain in adults.

Opioids have long been the go to option, or cornerstone of pain management, however, the potential for the adverse events associated with the use of opioids in veterinary patients is universally accepted.38 I have seen how distressing it can be for a family to see their pet experiencing any of the unpleasurable side effects of opioids including urine retention, delayed bowel movements, whining, panting, disorientation, or other manifestations of dysphoria. Those are just some of the challenges that clinicians face when using opioids for chronic pain management. Considering the ongoing consequences of the opioid epidemic, there is a search for pain management solutions that are innovative, prone to less adverse events, and are more effective. As the scientific community begins to evaluate the evidence for use of CBD , it is clear that more research is needed.

Anecdotal reports of CBDs efficacy as a pain reliever are ubiquitous but more are turning to scientific data for evidence of CBDs efficacy. A study in 2020 evaluating effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients found that over half of chronic pain patients (53%) reduced or eliminated their opioids within 8 weeks after adding CBD-rich hemp extract to their regimens.5 Almost all CBD users (94%) reported quality of life improvements.5 And in a recent study evaluating orally consumed cannabinoids for long-lasting relief of allodynia in a mouse model, found that cannabinoids reduced hyperalgesia and a similar effect was not found with morphine.4 Mouse vocalizations were recorded throughout the experiment, and mice showed a large increase in ultrasonic, broadband clicks after sciatic nerve injury, which was reversed by THC, CBD, and morphine.4 The study demonstrated that cannabinoids provide long-term relief of chronic pain states.4 If research shows that use of cannabinoids in animals, specifically, CBD, can help to decrease the use of opioids for pain management, that would help make more animals comfortable and potentially help to fight the tragic epidemic of human prescription opioid abuse. Further research is needed in a variety of species, specifically, both the canine and feline species.

Bone Healing

Both general veterinary practitioners and veterinary surgeons commonly diagnose and treat fractures. A large retrospective study of fracture incidence in dogs in North America has not been published since 1994; however, the findings from that study are still informative regarding the frequency of bone injuries. That study demonstrated that approximately 24% of all patients in the population studied over a 10 year period were affected by a disorder of the musculoskeletal system, with fractures contributing the largest proportion (over 29%) of all of the diagnosis of the appendicular skeletal system.7 Although that research is dated, the conclusions from this study - at the very least, indicate that fractures are commonplace in the clinical veterinary setting.7 Fracture repair has gradually become more straightforward due to improvements in technology. Because of these innovations, speciality surgeons and general practitioners who repair fractures have begun to see better surgical outcomes. So whether you primarily stabilize fractures with implants, or if external coaptation of fractures with the intention to refer (or perhaps as the primary means of fixation) is your treatment of choice, all veterinary practitioners aim to help fractured bones heal quickly. Despite these technological improvements, bone healing can be protracted or non existent with some fractures. There are a variety of options at a veterinarians disposal to kick-start the healing process but perhaps in the near future, CBD may be added to that armamentarium. The effect of CBD in fracture healing has been investigated evaluating bone callus formation in femur fractures in a rat model.8 The findings demonstrated enhanced biomechanical properties of healing fractures in those given CBD compared with a control group.8 This effect was not found in those only given 9-THC. Moreover, the bone forming effects (osteogenic) of CBD were weakened when test subjects were given equal amounts of CBD and 9-THC.6 Another in vivo research study indicated that when CBD is incorporated into a surface that promotes bone growth (osteoconductive scaffold) it can stimulate stem cell migration and osteogenic differentiation.9 Further studies are needed to better evaluate the role of CBD in healing and bone metabolism of companion animals so that these findings can be applied in the clinical setting.

Additionally, cannabis has been shown to be a useful addition in treatment plans optimized to improve bone health in laboratory studies. A study endeavored to more closely understand the role of CB2 receptors in maintaining bone health. CB2 receptors in bone cells have been linked to maintaining bone density and stimulating growth, and may therefore have a part in reversing the effects of osteoporosis.10 One study evaluating role of CB2 receptors, found that in mice whose genes had been altered to remove the CB1 or CB2 receptors, those that developed signs of bone weakness that were far more pronounced than those in the control group.12 Another study in 2009, investigated the relationship between CB2 expression and bone disease in humans. The study found that people with dysfunctional CB2 receptors to have significantly weaker hand bones.11

Arthritis

Osteoarthritis (OA) affects many dogs, large and small. Most often, OA is the consequence of a developmental orthopedic disease that often affects a single joint or a pair of joints, and, less often, affects multiple joints. It is axiomatic that Mother Nature likes symmetry thus developmental orthopedic diseases frequently affect both left and right joints. For example, hip dysplasia is reportedly bilateral in >60% of affected dog,s13 and elbow dysplasia is bilateral in approximately 50% of affected dogs.14 Osteoarthritis occurs secondary to a myriad of primary orthopedic conditions that affect a variety of joints including: the hip (most common causes of OA in the hip: hip dysplasia, Perthes disease); stifle (patellar luxation, cranial cruciate ligament disease, osteochondritis dissecans [OCD]); elbow (elbow dysplasia, elbow OCD, fragmentation of the medial coronoid process, incomplete ossification of the humeral condyle); shoulder (shoulder OCD, developmental shoulder subluxation); tarsus (OCD of the talus), and carpus (carpal laxity, carpal subluxation secondary to chondrodystrophy); and metacarpophalangeal (MCP) and metatarsophalangeal (MTP) joint degenerative osteoarthritis (digital osteoarthritis) .

Cannabinoids were found to treat pain secondary to inflammation in a variety of studies on humans. Some of the most compelling research has shown that cannabis can reduce the inflammation in the joint caused in human patients diagnosed with immune mediated arthritis.15 One study found that cannabinoids could simultaneously reduce the secretion of cytokines involved in inflammation from one type of TH immune cells, which were being under-produced, while also increasing their numbers to correct their scarcity.15 Furthermore in a study in 2003, researchers found that plant-based cannabinoids could suppress the expression of interleukin-1betaone of the most prominent markers for inflammation in patients with rheumatoid arthritisby as much as 50%.16 And finally, in 2006, transdermal applications of CBD were shown to decrease biomarkers that can contribute to neurogenic inflammation in a sample of arthritic rats. 17

A report published in the journal of PAIN, lead by researchers at Baylor College of Medicine revealed the results of a large, double blinded, placebo controlled study on the positive effects CBD had in the fight against osteoarthritis.18 The study was designed with two main goals: The first portion of the research studied the effect CBD had on the inflammatory molecules and cells in mice.18 The second portion of the study, investigated whether CBD improved the quality of life in dogs diagnosed with osteoarthritis. In lab tests and in mouse models, CBD significantly decreased the production of natural chemicals that promote inflammation and it increased the natural chemicals that fight inflammation.18 Essentially, what they saw was a drop in proinflammatory cytokines and an increase in anti-inflammatory cytokines. 18 For dogs with osteoarthritis, CBD significantly decreased pain and increased mobility in a dose-dependent fashion. Importantly, A lower dose of liposomal CBD was as effective as the highest dose of nonliposomal CBD, indicating that the effect of CBD was quicker and more effective when CBD was delivered encapsulated in liposomes than without.18 Blood samples indicated no significant harmful side effects, or adverse events, over the 4-week analysis period.18 Although this study is very promising and it supports the safety and therapeutic potential of hemp-derived CBD for relieving arthritic pain in dogs, it is important to consult with your pets veterinarian before giving any supplement or medication.

In the veterinary population, use of cannabidiol and other alternative treatments may have the potential to obviate the need for other medications, and thus spare patients from adverse effects associated with their use. More likely, the use of cannabinoids could be additive or synergistic in a multimodal treatment strategy and could increase quality-of-life issues associated with painful arthritic conditions.

Intervertebral Disk Disease

As our patients age, discs in the spine also undergo degenerative changes. Thus, degeneration of intervertebral discs is evitable. This process of degeneration is multifactorial process and it involves hypoxia, inflammation, neoinnervation, accelerated catabolism, and reduction in water and glycosaminoglycan content.39 The magnitude and severity of disc degeneration can vary widely between patients. The most common locations of clinically relevant disc disease are located in the cervical spine, thoracolumbar spine, and the lumbosacral spine.40 Although there are various manifestations of disc disease, broad classifications of Hansen Type I and Type II are typically used to describe the condition. In short, disc material may either extrude (acute herniations) or protrude (chronic herniations), both of which compress the spinal cord which ultimately can cause pain, paresis, paralysis and other neurological deficits.40 The prevalence of thoracolumbar disc disease dogs has been estimated at 3.5%.40 Depending on the neurologic examination, diagnosis, severity, prognosis, and other factors, surgery may be recommended to decompress the spinal cord.

After surgical decompression, there are a host of challenges that the the patient, the family, and the surgeon, may have to work through including a potentially protracted recovery, recurrence of neurological signs, post surgical pain, spinal instability, urinary disorders, (cystitis, urinary tract infection, urinary retention, micturition disorders), ascending myelomalacia, and others.41 Could CBD play a part in helping to improve those affected by disc disease pre-, intra-, or post-operatively and what types of spinal disorders could benefit from CBD? A study conducted on the use of CBD in mice with degenerative disc disease showed promise in mitigating the effect of disc damage and wear.19 Instead of being ingested orally, CBD was injected at the site of the disc. Researchers investigated the effects of cannabidiol intradiscal injection using a combination of MRI and histological analyses.19 A puncture was created in the disc and then CBD was injected into the disc (30, 60 or 120 nmol) shortly after.19 The effects of intradiscal injection of cannabidiol were analyzed within 2 days by MRI.17 Fifteen days later, the group that received cannabidiol 120 nmol was resubmitted to MRI examination and then to histological analyses after the cannabidiol injection.19 What they found was that cannabidiol significantly decreased the effects of disc injury induced by the needle puncture.19 These results suggest that this compound could be useful in the treatment of intervertebral disc degeneration perhaps using a novel route of administration.

Unfortunately, the exact mechanism for how CBD oil helped protect disc damage is still being investigated. The hope is that the neuroprotective properties of cannabidiol can also be found in the study of canine and feline disc disease to ultimately improve functional recovery.

References:

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Manzanares J, Julian MD, Carrascosa A. Role of the Cannabinoid System in Pain Control and Therapeutic Implications for the Management of Acute and Chronic Pain Episodes Curr Neuropharmacol. 2006 Jul; 4(3): 239257.

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Capano A, Weaver R, Burkman E. Evaluation of the effects of CBD hemp extract on opioid use and quality of life indicators in chronic pain patients: a prospective cohort study. Postgrad Med. 2020 Jan;132(1):56-61. doi:10.1080/00325481.2019.1685298. Epub 2019 Nov 12.

Abraham AD, Leung EJ, Wong BA, Rivera ZM, Kruse LC, Clark JJ, Land BB. Orally consumed cannabinoids provide long-lasting relief of allodynia in a mouse model of chronic neuropathic pain. Neuropsychopharmacology. 2020: 45:11051114.

Johnson, J., Austin, C., & Breur, G. Incidence of Canine Appendicular Musculoskeletal Disorders in 16 Veterinary Teaching Hospitals from 1980 through 1989. Veterinary and Comparative Orthopaedics and Traumatology, 07(02), 5669. (1994). doi:10.1055/s-0038-1633097

Kogan NM, Melamed E, Wasserman E. Cannabidiol, a Major Non-Psychotropic Cannabis Constituent Enhances Fracture Healing and Stimulates Lysyl Hydroxylase Activity in Osteoblasts J Bone Miner Re. 2015 Oct;30(10):1905-13. doi: 10.1002/jbmr.2513. Epub 2015 May 10.

Kamali, A., Oryan, A., Hosseini, S., Ghanian, M. H., Alizadeh, M., Baghaban Eslaminejad, M., & Baharvand, H. Cannabidiol-loaded microspheres incorporated into osteoconductive scaffold enhance mesenchymal stem cell recruitment and regeneration of critical-sized bone defects. Materials Science and Engineering: (2019). C, 101, 6475. doi:10.1016/j.msec.2019.03.070

Bab I, Zimmer A. Cannabinoid Receptors and the Regulation of Bone Mass. British Journal of Pharmacology. 2007 153:182-188 doi:10.1038/sj.bjp.0707593

I. Idris, A. Cannabinoid Receptors as Target for Treatment of Osteoporosis: A Tale of Two Therapies. Current Neuropharmacology. 2010. 8(3), 243253. doi:10.2174/157015910792246173

Meliha Karsak et al. The Cannabinoid Receptor Type 2 (CNR2) Gene Is Associated with Hand Bone Strength Phenotypes in an Ethnically Homogeneous Family Sample. Human Genetics. 2009. 5:629-36 doi:10.1007/s00439-009-0708-8.

Loder, R. T., & Todhunter, R. J. The Demographics of Canine Hip Dysplasia in the United States and Canada. Journal of Veterinary Medicine. 2017 115. doi:10.1155/2017/5723476

ONeill DG, Brodbelt DC, Hodge R,. Church DB, Meeson RL. Epidemiology and clinical management of elbow joint disease in dogs under primary veterinary care in the UK. Canine Medicine and Genetics. 2020 volume 7:1

Susan H. Pross et al. Differential Suppression of T-cell Subpopulations by THC (delta-9- tetrahydrocannabinol). International Journal of Immunopharmacology 12, no. 5 (1990): 539-44. doi:10.1016/0192-0561(90)90118-7

Robert B. Zurier et al. Suppression of Human Monocyte Interleukin-1 Production by Ajulemic Acid, a Nonpsychoactive Cannabinoid. Biochemical Pharmacology. 2003 4:649-55. doi:10.1016/s0006-2952(02)01604-0.

D.c. Hammell et al. Transdermal Cannabidiol Reduces Inflammation and Pain-related Behaviours in a Rat Model of Arthritis. European Journal of Pain. 2015 6:936-48. doi:10.1002/ejp.818

Verrico, C. D., Wesson, S., Konduri, V., Hofferek, C. J., Vazquez-Perez, J., Blair, E., Halpert, M. M. A randomized, double-blind, placebo-controlled study of daily cannabidiol for the treatment of canine osteoarthritis pain. 2020. Pain. doi:10.1097/j.pain.0000000000001896

Silveira, J. W., Issy, A. C., Castania, V. A., Salmon, C. E. G., Nogueira-Barbosa, M. H., Guimares, et al. Protective Effects of Cannabidiol on Lesion-Induced Intervertebral Disc Degeneration. 2014. PLoS ONE 9:12 doi:10.1371/journal.pone.0113161

Yam, M., Loh, Y., Tan, C., Khadijah Adam, S., Abdul Manan, N., & Basir, R. . General Pathways of Pain Sensation and the Major Neurotransmitters Involved in Pain Regulation. International Journal of Molecular Sciences. 2018 19(8), 2164. doi:10.3390/ijms19082164

Costigan, M., Scholz, J., & Woolf, C. J. Neuropathic Pain: A Maladaptive Response of the Nervous System to Damage. Annual Review of Neuroscience. 2009 32(1), 132. doi:10.1146/annurev.neuro.051508.135531

Arora A, Taliyan R, Sharma PL. Ameliorative Potential of Cannabis Sativa Extract on Diabetes Induced Neuropathic Pain in Rats. International Journal of Pharmaceutical Sciences and Research 1. 2010 https://www.researchgate.net/publication/216536386_Ameliorative_potential_of_cannabis_sativa_extract_

Mark S. Wallace et al., Efficacy of Inhaled Cannabis on Painful Diabetic Neuropathy. 2015. Pain 16(7): 616-27 doi:10.1016/j.jpain.2015.03.008.

Gruen, M. E., Roe, S. C., Griffith, E., Hamilton, A., & Sherman, B. L.. Use of trazodone to facilitate postsurgical confinement in dogs. Journal of the American Veterinary Medical Association. (2014) 245(3), 296301. doi:10.2460/javma.245.3.296

Serra, G., & Fratta, W. A possible role for the endocannabinoid system in the neurobiology of depression. Clinical Practice and Epidemiology in Mental Health. 2007. 3(1), 25. doi:10.1186/1745-0179-3-25

Kim, E. J., Pellman, B., & Kim, J. J. Stress effects on the hippocampus: a critical review. Learning & Memory. 2015. 22(9), 411416. doi:10.1101/lm.037291.114

Demirakca, T., Sartorius, A., Ende, G., et al. Diminished gray matter in the hippocampus of cannabis users: Possible protective effects of cannabidiol. 2010. Drug and Alcohol Dependence. doi:10.1016/j.drugalcdep.2010.09.020

Mateus M. Bergamaschi et al. Cannabidiol Reduces the Anxiety Induced by Simulated Public Speaking in Treatment-Nave Social Phobia Patients. Neuropsychopharmacology. 2011 36(6):1219-26 doi:10.1038/npp.2011.6.

Jos Alexandre S Crippa et al. Neural Basis of Anxiolytic Effects of Cannabidiol (CBD) in Generalized Social Anxiety Disorder: A Preliminary Report. Journal of Psychopharmacology. 2010. 25: 1doi:10.1177/0269881110379283.

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Pamplona, F. A., da Silva, L. R., & Coan, A. C. Potential Clinical Benefits of CBD-Rich Cannabis Extracts Over Purified CBD in Treatment-Resistant Epilepsy: Observational Data Meta-analysis. 2018. Frontiers in Neurology, 9. doi:10.3389/fneur.2018.00759

Palmieri B, Laurino C, Vadal M. A therapeutic effect of cbd-enriched ointment in inflammatory skin diseases and cutaneous scars. Mar-Apr 2019;170(2):e93-e99. doi: 10.7417/CT.2019.2116.

Sangiovanni, E., Fumagalli, M., Pacchetti, B., Piazza, S., et al.. Cannabis sativa L. extract and cannabidiol inhibit in vitro mediators of skin inflammation and wound injury. (2019). Phytotherapy Research. doi:10.1002/ptr.6400

B. Van Klingeren and M. Ten Ham. Antibacterial Activity of 9-tetrahydrocannabinol and Cannabidiol. 1976. 42(1-2): 9-12 doi:10.1007/bf00399444.

Giovanni Appendino et al. Antibacterial Cannabinoids From Cannabis Sativa: A StructureActivity Study. 2008. Journal of Natural Products 71(8):1427-430, doi:10.1021/np8002673

McIver, V., Tsang, A., Symonds, N., Perkins, N., et al. Effects of topical treatment of cannabidiol extract in a unique manuka factor 5 manuka honey carrier on second intention wound healing on equine distal limb wounds: a preliminary study. 2020. Australian Veterinary Journal. doi:10.1111/avj.12932

White, D. M., Mair, A. R., & Martinez-Taboada, F. Opioid-free anaesthesia in three dogs. Open Veterinary Journal. 2017 7(2), 104. doi:10.4314/ovj.v7i2.5

Hansen T, Smolders LA, Tryfonidou MA, et al: The Myth of Fibroid Degeneration in the Canine Intervertebral Disc: A Histopathological Comparison of Intervertebral Disc Degeneration in Chondrodystrophic and Nonchondrodystrophic Dogs. Vet Pathol 2017 Vol 54 (6) pp. 945-952.

40. Jeffery ND, Levine JM, Olby NJ, et al: Intervertebral disk degeneration in dogs: consequences, diagnosis, treatment, and future directions. J Vet Intern Med 2013 Vol 27 (6) pp. 1318-33.

41. Balducci F, Canal S, Contiero B, et al: Prevalence and Risk Factors for Presumptive Ascending/Descending Myelomalacia in Dogs after Thoracolumbar Intervertebral Disk Herniation. J Vet Intern Med 2017 Vol 31 (2) pp. 498-504.

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Unraveling the use of CBD in veterinary medicine - Jill Lopez

Skin Stem Cells Comments Off on Unraveling the use of CBD in veterinary medicine – Jill Lopez | September 1st, 2020

In an August 28 special issue of the peer-reviewed online journal OBM Transplantation, stem cell biotechnology company Asymmetrex has now published a report describing how its technology for determining the specific dosage of therapeutic tissue stem cells works. The new technology is poised to revolutionize stem cell science and stem cell medicine by giving the long-needed means to quantity their essential focus, tissue stem cells.

BOSTON, Sept. 1, 2020 /PRNewswire-PRWeb/ --Stem cell biotechnology company, Asymmetrex, has been counting tissue stem cells like those used for bone marrow and cord blood transplantation therapies for a few years now. Recently, the company announced the issue of patents for its first-in-kind technology both in the U.S. and the U.K. However, until last Friday, August 28, Asymmetrex had not reported in the peer-reviewed academic literature how it achieves this feat that had been pursued by many distinguished labs for more than six decades.

Now in a report published in a special issue of OBM Transplantation, a peer-review journal for transplantation medicine research, Asymmetrex completes its introduction of the new technology to the fields of stem cell science and stem cell medicine. The report is the second invited article published in a special issue focused on the "Isolation and Characterization of Adult Therapeutic Cells."

The new report describes Asymmetrex's discovery of mathematical formulas, call algorithms, that can be used to determine the number of stem cells in complex tissue cell preparations, like experimental samples or patient treatments. The stem cell counting algorithms are specific for different types of tissue stem cells. So, the algorithms defined for blood stem cells are distinct from the algorithms for liver stem cells, or lung stem cells. Once an algorithm is defined by the Asymmetrex technology, it can be used repeatedly as a simple, rapid, and inexpensive test to determine the quantity and dosage of its specific tissue stem cell type.

Asymmetrex's founder and director, James L. Sherley, M.D., Ph.D., anticipated the August publication of the new algorithms in a talk given earlier at the 6th Annual Perinatal Stem Cell Society Congress in March of this year. Then and now, he says that he believes, "Now that the tissue stem cell counting algorithms are available, everything will change" in stem cell science and medicine.

Prior to Asymmetrex's technology, there was no method for counting tissue stem cells in research, medicine, or for any other of their many uses. So, the impact of the stem cell counting algorithms in research and medicine is far-reaching. Such information is a game changer for accelerating progress in stem cell science and stem cell medicine, including improving treatments like gene therapy whose success depends on targeting tissue stem cells. There will also be tremendous gains in cell biomanufacturing, drug development, and environmental toxicology, all whose capabilities are currently limited by the lack of a facile means to quantify tissue stem cells.

To make the new counting technology readily accessible for evaluation by the greater academic, medical, and industrial stem cell communities, Asymmetrex provides free tissue stem cell counting on its company website.

About Asymmetrex

Asymmetrex, LLC is a Massachusetts life sciences company with a focus on developing technologies to advance stem cell medicine. The company's U.S. and U.K. patent portfolio contains biotechnologies that solve the two main technical problems production and quantification that have stood in the way of effective use of human adult tissue stem cells for regenerative medicine and drug development. Asymmetrex markets the first technology for determination of the dose and quality of tissue stem cell preparations (the "AlphaSTEM Test") for use in stem cell transplantation therapies and pre-clinical drug evaluations. Asymmetrex is a member company of the Advanced Regenerative Manufacturing Institute BioFabUSA and the Massachusetts Biotechnology Council.

SOURCE Asymmetrex, LLC

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New Report Begins a New Era of Stem Cell Science and Medicine: Stem Cell Biotechnology Company Asymmetrex Tells How It Counts Therapeutic Tissue Stem...

Bone Marrow Stem Cells Comments Off on New Report Begins a New Era of Stem Cell Science and Medicine: Stem Cell Biotechnology Company Asymmetrex Tells How It Counts Therapeutic Tissue Stem… | September 1st, 2020

The parents of a girl battling a deadly blood disorder are begging people to join the stem cell donor register to save her life after her only match in the world pulled out at the last minute.

Evie Hodgson, eight, who suffers from aplastic anaemia, was due to have a bone marrow transplant this month but her donor backed out at the last possible moment.

Her mum, Tina, says the chances of finding another donor are so slim that doctors are now planning a different course of treatment. But, in future, a stem call transplant is Evies best hope of being cured.

The schoolgirl, from Whitby, North Yorks, was first taken to hospital with a rash and was diagnosed with aplastic anaemia in May.

After a global donor search was launched, a 10/10 match was found and the anonymous donor agreed to the procedure. In preparation, Evie had to have dental work and one of her ovaries was removed. But on August 14 the donor pulled out.

Tina, 37, who works at RAF Flyingdales, in Pickering, North Yorks, said: We were devastated, it was a huge blow. We have no idea why the donor changed their mind. Evie has already been through so much. She thought she had a donor and now she doesnt.

The donor pulling out is quite hard-hitting, but we want to raise awareness of the stem cell register. Its so easy to be a donor. Its just like giving blood, but you could save a childs life. Its so easy to join but only 1% of the UK population is registered.

Evie said: I need this transplant to save my life. Please sign the register to help.

Tina added: The condition Evie has is life-threatening. She wont survive without a transplant. We are desperately appealing for people to sign the stem cell register.

Evie was diagnosed with the condition after she developed a pin-prick rash on her back, which didnt fade. Tests revealed she had low blood platelet levels and she was told she needed a bone marrow transplant.

Aplastic anaemia is a rare life-threatening condition where the bone marrow fails to produce enough blood cells. Around 100-150 people are diagnosed in the UK each year.

Treatment can include immunosuppressants, chemotherapy, blood transfusions, or blood and bone marrow transplants.

Neither Tina, dad Andy, 49, or brother William, five, were a match and so an international search was launched.

Tina said: Our world crumbled when Evie was diagnosed. Evie knew shed need chemotherapy. She donated her hair to The Little Princess Trust, after making friends with poorly children who have lost all their hair.

Evie will be treated with immunosuppressants while the search for a donor continues.

Blood cancer charity Anthony Nolan is looking for stem cell donors between the ages of 16-30.

Research shows that younger donors result in better outcomes for patients.

To find out how to donate click here.

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Parents plea for stem cell help to save life of daughter with rare blood disorder - Mirror Online

Bone Marrow Stem Cells Comments Off on Parents plea for stem cell help to save life of daughter with rare blood disorder – Mirror Online | September 1st, 2020

Evie Hodgson, 8, was due to undergo a bone marrow transplant this month, but her only match in the world pulled out at the last minute (Picture: North News)

A little girl battling a rare blood disorder has issued a desperate plea for donors after her only match in the world pulled out at the last minute.

Evie Hodgson, 8, was due to undergo a bone marrow transplant this month but her donor cancelled just as she was getting prepared.

Mum Tina, of Whitby, North Yorkshire, said the chances of finding another donor are so slim doctors are planning a different course of treatment.

But the best hope Evie has of being cured is to find a stem cell transplant from a compatible donor.

The schoolgirl was diagnosed with deadly aplastic anaemia in May after she developed a pin prick rash on her back which didnt fade.

Tests revealed she had low blood platelet levels, which medics initially thought might be leukaemia but a biopsy found no cancerous cells.

They were then given the devastating diagnosis and Evie was told she would need a bone marrow transplant.

Tina, 37, dad Andy, 49, and five-year-old brother William, were sadly not a match so a worldwide search was launched to find a donor.

To the familys delight, a 10/10 match was found, with the anonymous donor agreeing to go ahead.

The family began to prepare for the transplant, including dental work and the removal of one of her ovaries, but to their horror, on August 14, they were told the donor had pulled out.

Tina, who works at RAF Flying Dales, said: We were devastated, it was a huge blow. We have no idea why the donor changed their mind. Everything is confidential.

Evie has already been through so much. She thought she had a donor and now she doesnt.

The donor pulling out is quite hard hitting but from our point of view we just want to raise awareness of the stem cell register.

Its so easy to be a donor. Its just like giving blood, but you could save a childs life. Some people dont even know they could be a match.

Its so easy to join the register but only about 1% of the UK population is registered.

Evie is set to undergo an immunosuppressant course of treatment while the search for a donor continues.

Her family have set up a Facebook group to raise awareness and to update progress on Evies journey.

Tina added: The condition Evie has is life-threatening. She wont survive without a transplant.

Thats why we are desperately appealing for any many people as possible to register as a stem cell donor.

Evie said: I need this transplant to save my life. Please sign the register to help save my life.

Get in touch with our news team by emailing us atwebnews@metro.co.uk.

For more stories like this,check our news page.

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Girl's only bone marrow donor in the world pulls out at last moment - Metro.co.uk

Bone Marrow Stem Cells Comments Off on Girl’s only bone marrow donor in the world pulls out at last moment – Metro.co.uk | September 1st, 2020

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Vor Biopharma, an oncology company pioneering engineered hematopoietic stem cells (eHSCs) for the treatment of cancer, and Metagenomi, a gene editing company discovering breakthrough systems for curing genetic disease, today announced that Vor will evaluate the potential use of Metagenomis gene editing technology to develop engineered hematopoietic stem cell-based therapies for the treatment of blood cancers, such as acute myeloid leukemia.

Cancer patients deserve therapies with strong effects on cancer cells and minimal effects on all other cells, said Tirtha Chakraborty, Ph.D., Vors VP and Head of Research. Our new partnership with Metagenomi will help us achieve this goal by engineering hematopoietic stem cells using precise yet flexible gene editing thereby ensuring that targeted therapies can live up to their name."

The collaboration is non-exclusive and applies to pre-clinical research only. Further terms of the agreement are not being disclosed.

This partnership unites two transformative technologies our proprietary gene editing enzymes, and Vors platform for engineering hematopoietic stem cells such that they are inherently treatment-resistant, said Brian C. Thomas, Metagenomis CEO and co-founder. We are excited to be working together to bring both of these cutting-edge approaches into the clinic.

About Vor Biopharma

Vor Biopharma aims to transform the lives of cancer patients by pioneering engineered hematopoietic stem cell (eHSC) therapies. By removing biologically redundant proteins from eHSCs, these cells become inherently invulnerable to complementary targeted therapies while tumor cells are left susceptible, thereby unleashing the potential of targeted therapies to benefit cancer patients in need.

Vors platform could be used to potentially change the treatment paradigm of both hematopoietic stem cell transplants and targeted therapies, such as antibody drug conjugates, bispecific antibodies and CAR-T cell treatments.

Vor is based in Cambridge, Mass. and has a broad intellectual property base, including in-licenses from Columbia University, where foundational work was conducted by inventor and Vor Scientific Board Chair Siddhartha Mukherjee, MD, DPhil.

About VOR33

Vors lead product candidate, VOR33, consists of engineered hematopoietic stem cells (eHSCs) that lack the protein CD33. Once these cells are transplanted into a cancer patient, we believe that CD33 will become a far more cancer-specific target, potentially avoiding toxicity to the normal blood and bone marrow associated with CD33-targeted therapies. Vor aims to improve the therapeutic window and effectiveness of CD33-targeted therapies, thereby potentially broadening the clinical benefit to patients suffering from acute myeloid leukemia.

About Metagenomi

Metagenomi is harnessing the vast information found in life on Earth to develop cures for genetic disease. Using proprietary data collected from around the world, Metagenomi has developed novel gene editing tools that enable next-generation gene and cell therapies.

Metagenomi is based out of Emeryville, California, and was founded by pioneers in the field of metagenomics, Jill Banfield and Brian C. Thomas. Metagenomi generates massive quantities of data from natural environments, producing complete genomes from organisms that are otherwise unknown. Metagenomi then unlocks the information captured in these genomes to develop game-changing in vivo and ex vivo therapeutics.

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Vor Biopharma and Metagenomi to Collaborate on Engineered Hematopoietic Stem-Cell Therapies - Business Wire

Bone Marrow Stem Cells Comments Off on Vor Biopharma and Metagenomi to Collaborate on Engineered Hematopoietic Stem-Cell Therapies – Business Wire | September 1st, 2020

THE family of a girl battling a deadly blood disorder are pleading for help after her only donor match in the world pulled out at the last minute.

Evie Hodgson, eight, who suffers from aplastic anaemia - also known as bone marrow failure - was due to have a transplant this month but her donor backed out.

4

Her mum, Tina Hodgson, says the chances of finding another donor are so slim that doctors are now planning a different course of treatment.

The youngster from Sleights, Whitby, was rushed to hospital with a rash during the coronavirus lockdown.

She was diagnosed with aplastic anaemia in May.

Amazingly, a match was found and preparations were underway for surgery.

But just weeks before the transplant, the donor pulled out and the family's "world fell apart, again".

However, the courageous pupil at Fyling Hall School, in Robin Hoods Bay, is determined to battle the disease.

Evie's mum told how the family received the diagnosis: "In the middle of the Covid lockdown, Evie woke up one morning with a red pin rash all over her body.

"We first thought it was meningitis because it wasn't fading under a tumbler but she had no other symptoms."

The family contacted the NHS 111 service and were advised to take Evie to Whitby A&E.

"The doctor took one look at her and thought it was sepsis," Tina said.

"She had IV antibiotics there and we were rushed to James Cook University Hospital by ambulance."

4

Evie then had blood tests at the Middlesbrough hospital which revealed her platelets were low - but her red and white blood cells were fine.

She was diagnosed with a platelet condition - known as ITP - and told she would need to return to hospital once per week for tests.

But when the family returned to Teesside one week later, tests revealed all Evie's cell counts were low.

The youngster was then immediately transferred to Great North Childrens Hospital in Newcastle.

Tina, who works at RAF Fylingdales, said: "Deep down we thought this is quite serious and I think everyone though it was leukaemia."

In May, further tests revealed that Evie didn't have cancerous cells - and not many cells at all - as doctors broke the devastating news that Evie was suffering from aplastic anaemia.

4

As the family received the diagnosis, Tina said: "As parents we said thank god it isn't cancer but then the nurse said this is just as bad, it is a lot harder to treat.

"Our world fell apart at that point."

Aplastic anemia is a condition that occurs when your body stops producing enough new blood cells.

Around 100-150 people are diagnosed in the UK each year.

Treatment can include immunosuppressants, chemotherapy, blood transfusions, or blood and bone marrow transplants.

Evie's first option was a bone marrow transplant as a cure, but mum Tina, dad Andy and Evies five-year-old brother William were not a match.

The next step was to search the international database for a bone marrow transplant.

And luckily, Evie's perfect donor - the only one in the world - was found and preparations for surgery were scheduled.

Evie had one of her ovaries removed, dental work carried out and even chopped off her Rapunzel-like locks to donate to The Little Princess Trust.

Speaking through tears about her brave little girl, Tina, 37, said: "Evie was always that girl at the hairdressers that wanted her hair like Rapunzel.

"When we've been in the hospital she has saw her friends with no hair.

"One day she said to me 'will I lose my hair?'. So I said probably, yes."

Evie then made the courageous decision to chop off her hair and is now sporting a beautiful curly bob despite fighting her own battle.

The brave youngster, who is also a keen singer, has also been entertaining other patients and staff in the hospital with her talents.

The family's second devastating blow came when Evie was in hospital and doctors broke the news the donor had pulled out.

4

"It was like the diagnosis all over again. We will never know why they pulled out," Tina added.

Evie is due to start a three-month immunosuppressive therapy treatment which aims for her body to generate bone marrow.

As the treatment has only a 60 per cent success rate, Evie's family are now raising awareness about joining the stem cell donation register.

Speaking about the importance of signing up, Tina said: "I was shocked to learn that only 2 per cent of the UK population is registered on the blood stem cell register.

"It is such an easy procedure, similar to giving blood.

"It is so easy to get on the register and donate if you are a match.

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"If people are made aware they could save someone's life. It isn't just Evie, there are so many families waiting for a donor."

You can join on the DKMS register, here, or through Anthony Nolan register, here.

A dedicated Facebook page has been set up to follow Evie's journey with aplastic anaemia - you can follow her progress here.

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Familys plea to help save girl, 8, after her only donor match in the world pulls out at the last minute - The Sun

Bone Marrow Stem Cells Comments Off on Familys plea to help save girl, 8, after her only donor match in the world pulls out at the last minute – The Sun | September 1st, 2020

The Hematopoietic Stem Cells Transplantation (HSCT) market research report study recently presented by AMR provides comprehensive knowledge on the development activities by Global industry players, growth possibilities or opportunities and market sizing for Hematopoietic Stem Cells Transplantation (HSCT) along with analysis by key segments, leading and emerging players, and their presence geographies. This is the latest report, covering the current COVID-19 impact on the market. The pandemic of Coronavirus (COVID-19) has affected every aspect of life globally. This has brought along several changes in market conditions

This research study has 125 pages, it covers the complete market overview of various profiled players and their development history, on-going development strategies along with the current situation.

Hematopoietic stem cells transplantation is the treatment of patients with blood dysfunction such as leukemia or aplastic anemia by intravenous injection of normal bone marrow cells.

The research benefits in recognizing and following arising players in the market and their portfolios, to enhance decision-making abilities and helps to create effective counter-strategies to gain a competing advantage. Some of the players profiled/ part of study coverage are ViaCord, Vita34, Omeros Corporation, Cesca Therapeutics, Smart Cells, Cryo-Cell, Kiadis Pharma, Cryo-Save AG.

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AMRs research team has examined complete data across the globe comprising 20+ countries with a comprehensive data plan spread from 2013 to 2026 and approximately 12+ regional indicators complemented with 20+ company level coverage.

The study is organized utilizing data and knowledge sourced of various primary and secondary sources, proprietary databases, company/university websites, regulators, conferences, SEC filings, investor presentations and featured press releases from company sites and industry-specific third party sources.

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Characteristics of the Table of Content:

The comprehensive study presented by considering all the important aspects and sections. Some of these were

Hematopoietic Stem Cells Transplantation (HSCT) MARKET RESEARCH SCOPE OBJECTIVES, TARGET AND KEY FINDINGS

Preferably, that approaching major uptrend failed to arrive on schedule, but the Hematopoietic Stem Cells Transplantation (HSCT) market raised without posting any drops and surely witnesses zeniths in years to come.

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Leukemia, Lymphoproliferative Disorders, Solid Tumors, Non-Malignant Disorders, Others segment interpreted and sized in this research report by application/end-users reveals the inherent growth and several shifts for the period 2014 to 2026.

The changing dynamics supporting the growth perform it perilous for manufacturers in this extent to keep up-to-date with the changing pace of the market. Find out which segment is doing great and will return in strong earnings adding the significant drive to overall growth.

Furthermore, the research contributes an in-depth overview of regional level break-up categorized as likely leading growth rate territory, countries with the highest market share in past and current scenario. Some of the geographical break-up incorporated in the study are North America (Covered in Chapter 7 and 14), United States, Canada, Mexico, Europe (Covered in Chapter 8 and 14), Germany, UK, France, Italy, Spain, Russia.

In the Type segment Autologous Transplant, Allogenic Transplant included for segmenting Hematopoietic Stem Cells Transplantation (HSCT) market by type.

The industry is performing well and few emerging business institutions are in their peak as per growth rate and their existence with major players of Hematopoietic Stem Cells Transplantation (HSCT) market whereas conflict between 2 Global economies continues in 2020.

ViaCord, Vita34, Omeros Corporation, Cesca Therapeutics, Smart Cells, Cryo-Cell, Kiadis Pharma, Cryo-Save AG major key players included in this research along with their sales and revenue data show how they are performing well?

Find out more about this report at: https://www.amplemarketreports.com/report/covid-19-outbreak-global-hematopoietic-stem-cells-transplantation-industry-1910831.html

Thanks for reading this article, you can also get individual chapter wise section or region wise report versions like North America, Western / Eastern Europe or Southeast Asia.

With the given market data, Research on Global Markets offers customization according to specific needs.

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Ample Market Research provides comprehensive market research services and solutions across various industry verticals and helps businesses perform exceptionally well. Our end goal is to provide quality market research and consulting services to customers and add maximum value to businesses worldwide. We desire to delivery reports that have the perfect concoction of useful data. Our mission is to capture every aspect of the market and offer businesses a document that makes solid grounds for crucial decision making.

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Comprehensive Report on Hematopoietic Stem Cells Transplantation Market Set to Witness Huge Growth by 2026 | ViaCord, Vita34, Omeros Corporation,...

Bone Marrow Stem Cells Comments Off on Comprehensive Report on Hematopoietic Stem Cells Transplantation Market Set to Witness Huge Growth by 2026 | ViaCord, Vita34, Omeros Corporation,… | September 1st, 2020

Data on all eight patients demonstrate sustained engraftment and supranormal IDUA enzyme expression

Translation of metabolic correction to clinical outcomes in first two patients continues to support potential of hematopoietic stem cell gene therapy in a second neurometabolic disorder

Data support planned initiation of registrational trial in 2021

BOSTON and LONDON, Sept. 01, 2020 (GLOBE NEWSWIRE) -- Orchard Therapeutics(Nasdaq: ORTX), a global gene therapy leader, today announced additional interim data from an ongoing proof-of-concept clinical trial evaluating the safety and efficacy of OTL-203, an investigationalex vivoautologous hematopoietic stem cell (HSC) gene therapy in development for the treatment of mucopolysaccharidosis type I (MPS-I) at theSan Raffaele Telethon Institute for Gene Therapy(SR-Tiget) inMilan, Italy. The readout from the primary endpoint at one year of follow-up is expected in 2021. Today's results are being shared virtually in an invited oral presentation at the 46th Annual Meeting of the European Society for Blood and Bone Marrow Transplantation (EBMT).

We continue to see encouraging data from the ongoing clinical trial in MPS-I, including promising preliminary clinical effects on motor development, acquisition of cognitive skilIs and growth in the first two patients that were treated now 1.5 and 2 years ago, respectively. Additionally, new preliminary analyses of radiological outcome measures suggest that treatment with OTL-203 leads to stabilization or improvement in disease-related neurological abnormalities, as measured by brain and spine MRI, which we look to confirm with longer follow-up, saidMaria Ester Bernardo, M.D., Ph.D., principal investigator at SR-Tiget. "These data, taken together with those from clinical studies of HSC gene therapy for other metabolic disorders and leukodystrophies, support the potential for this therapeutic approach to correct a wide spectrum of multisystemic manifestations of the disease, bringing clinically meaningful benefits for patients.

Interim Study Results

Eight patients with the severe Hurler subtype of MPS-I had been treated with OTL-203 in the ongoing proof-of-concept study, which completed enrollment in December 2019. As of July 2020, all patients had been followed for a minimum of six months, with the longest follow-up extending out to 24 months. Treatment with OTL-203 was generally well-tolerated with a safety profile consistent with the selected conditioning regimen. Consistent with previous analyses, treatment across all eight patients continued to demonstrate:

We continue to see positive trends in all biomarker and clinical measures as we follow patients in the OTL-203 proof of concept study for longer periods of time, saidBobby Gaspar, M.D., Ph.D., chief executive officer of Orchard. With a growing amount of data to support advancing this program, we have recently convened a panel of disease experts to develop a design for a registrational trial that we intend to take to the regulators in advance of initiating the study in 2021 and ultimately progressing towards commercialization.

About OTL-203 and MPS-I

Mucopolysaccharidosis type I (MPS-I) is a rare, inherited neurometabolic disease caused by a deficiency of the alpha-L-iduronidase (IDUA) lysosomal enzyme, which is required to break down sugar molecules called glycosaminoglycans (also known as GAGs). The accumulation of GAGs across multiple organ systems results in symptoms including neurocognitive impairment, skeletal deformity, loss of vision and hearing, and cardiovascular and pulmonary complications. MPS-I occurs at an overall estimated frequency of one in every 100,000 live births. There are three subtypes of MPS-I; approximately 60 percent of children born with MPS-I have the most severe subtype, called Hurler syndrome, and rarely live past the age of 10 when untreated.

Treatment options for MPS-I include hematopoietic stem cell transplant and chronic enzyme replacement therapy, both of which have significant limitations. Though early intervention with enzyme replacement therapy has been shown to delay or prevent some clinical features of the condition, it has only limited efficacy on neurological symptoms. OTL-203 is an investigationalex vivoautologous hematopoietic stem cell gene therapy being studied for the treatment of MPS-I. Orchard was granted an exclusive worldwide license to intellectual property rights to research, develop, manufacture and commercialize the gene therapy program for the treatment of MPS-I developed by theSan Raffaele Telethon Institute for Gene TherapyinMilan, Italy.

About Orchard

Orchard Therapeuticsis a global gene therapy leader dedicated to transforming the lives of people affected by rare diseases through the development of innovative, potentially curative gene therapies. Ourex vivoautologous gene therapy approach harnesses the power of genetically modified blood stem cells and seeks to correct the underlying cause of disease in a single administration. In 2018, Orchard acquired GSKs rare disease gene therapy portfolio, which originated from a pioneering collaboration between GSK and theSan Raffaele Telethon Institute for Gene Therapy inMilan, Italy. Orchard now has one of the deepest and most advanced gene therapy product candidate pipelines in the industry spanning multiple therapeutic areas where the disease burden on children, families and caregivers is immense and current treatment options are limited or do not exist.

Orchard has its global headquarters inLondonandU.S.headquarters inBoston. For more information, please visitwww.orchard-tx.com, and follow us onTwitterandLinkedIn.

Availability of Other Information About Orchard

Investors and others should note that Orchard communicates with its investors and the public using the company website (www.orchard-tx.com), the investor relations website (ir.orchard-tx.com), and on social media (TwitterandLinkedIn), including but not limited to investor presentations and investor fact sheets,U.S. Securities and Exchange Commissionfilings, press releases, public conference calls and webcasts. The information that Orchard posts on these channels and websites could be deemed to be material information. As a result, Orchard encourages investors, the media, and others interested in Orchard to review the information that is posted on these channels, including the investor relations website, on a regular basis. This list of channels may be updated from time to time on Orchards investor relations website and may include additional social media channels. The contents of Orchards website or these channels, or any other website that may be accessed from its website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Forward-Looking Statements

This press release contains certain forward-looking statements about Orchards strategy, future plans and prospects, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements may be identified by words such as anticipates, believes, expects, plans, intends, projects, and future or similar expressions that are intended to identify forward-looking statements. Forward-looking statements include express or implied statements relating to, among other things, Orchards business strategy and goals, the therapeutic potential of Orchards product candidates, including the product candidates referred to in this release, Orchards expectations regarding the timing of clinical trials for its product candidates, including the product candidates referred to in this release, the timing of interactions with regulators and regulatory submissions related to ongoing and new clinical trials for its product candidates, the timing of announcement of clinical data for its product candidates, and the likelihood that such data will be positive and support further clinical development and regulatory approval of these product candidates. These statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, many of which are beyond Orchards control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, these risks and uncertainties include, without limitation: the severity of the impact of the COVID-19 pandemic on Orchards business, including on clinical development, its supply chain and commercial programs; the risk that Orchard will not realize the anticipated benefits of its new strategic plan or the expected cash savings associated with such plan; the risk that any one or more of Orchards product candidates, including the product candidates referred to in this release, will not be successfully developed, approved or commercialized; the risk of cessation or delay of any of Orchards ongoing or planned clinical trials; the risk that Orchard may not successfully recruit or enroll a sufficient number of patients for its clinical trials; the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical studies or clinical trials will not be replicated or will not continue in ongoing or future studies or trials involving Orchards product candidates or that long-term adverse safety findings may be discovered; the delay of any of Orchards regulatory submissions; the failure to obtain marketing approval from the applicable regulatory authorities for any of Orchards product candidates or the receipt of restricted marketing approvals; and the risk of delays in Orchards ability to commercialize its product candidates, if approved. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements.

Other risks and uncertainties faced by Orchard include those identified under the heading "Risk Factors" in Orchards quarterly report on Form 10-Q for the quarter endedJune 30, 2020, as filed with theU.S. Securities and Exchange Commission(SEC), as well as subsequent filings and reports filed with theSEC. The forward-looking statements contained in this press release reflect Orchards views as of the date hereof, and Orchard does not assume and specifically disclaims any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required by law.

Contacts

InvestorsRenee LeckDirector, Investor Relations+1 862-242-0764Renee.Leck@orchard-tx.com

MediaMolly CameronManager, Corporate Communications+1 978-339-3378media@orchard-tx.com

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Orchard Therapeutics Announces Additional Interim Results from Proof-of-Concept Study of OTL-203 for MPS-I - BioSpace

Bone Marrow Stem Cells Comments Off on Orchard Therapeutics Announces Additional Interim Results from Proof-of-Concept Study of OTL-203 for MPS-I – BioSpace | September 1st, 2020

Bone marrowaspiration and trephine biopsy are usually performed on the back of the hipbone, or posterior iliac crest. An aspirate can also be obtained from the sternum (breastbone). For the sternal aspirate, the patient lies on their back, with a pillow under the shoulder to raise the chest. A trephine biopsy should never be performed on the sternum, due to the risk of injury to blood vessels, lungs or the heart.

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The need to selectively isolate and concentrate selective cells, such as mononuclear cells, allogeneic cancer cells, T cells and others, is driving the market. Over 30,000 bone marrow transplants occur every year. The explosive growth of stem cells therapies represents the largest growth opportunity for bone marrow processing systems.Europe and North America spearheaded the market as of 2016, by contributing over 74.0% to the overall revenue. Majority of stem cell transplants are conducted in Europe, and it is one of the major factors contributing to the lucrative share in the cell harvesting system market.

In 2016, North America dominated the research landscape as more than 54.0% of stem cell clinical trials were conducted in this region. The region also accounts for the second largest number of stem cell transplantation, which is further driving the demand for harvesting in the region.Asia Pacific is anticipated to witness lucrative growth over the forecast period, owing to rising incidence of chronic diseases and increasing demand for stem cell transplantation along with stem cell-based therapy.

Japan and China are the biggest markets for harvesting systems in Asia Pacific. Emerging countries such as Mexico, South Korea, and South Africa are also expected to report lucrative growth over the forecast period. Growing investment by government bodies on stem cell-based research and increase in aging population can be attributed to the increasing demand for these therapies in these countries.

Major players operating in the global bone marrow processing systems market are ThermoGenesis (Cesca Therapeutics inc.), RegenMed Systems Inc., MK Alliance Inc., Fresenius Kabi AG, Harvest Technologies (Terumo BCT), Arthrex, Inc. and others

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Bone Marrow Processing Systems Market Business Analysis, New Innovation | Share, Revenue, And Sales Till 2025 - The Scarlet

Bone Marrow Stem Cells Comments Off on Bone Marrow Processing Systems Market Business Analysis, New Innovation | Share, Revenue, And Sales Till 2025 – The Scarlet | August 31st, 2020

If you think light therapyis a high-tech way to heal your skin, wait until you hear about this trending skin care ingredient thats going to sound incredibly brilliant: stem cells.

Dermatologists have turned to stem cells to fight wrinkles and improve skin turnover and overall appearance. Yep, you heard right. Stem cells, the same ones used in innovative medical research to treat Alzheimers and certain types of cancer, are now being sold over the counter in the form of creams, serums and other skin care products. Except theres one major difference here: These stems cells are usually derived from plants (or occasionally animals). However, they work similarly to human stem cells and may offer anti-aging benefits for your skin.

Human stem cells are unique because of their ability to divide. In certain organs, they can even become specialized to repair and replace damaged tissues. Stemcellsare rapidly dividingcellsin the body that have the ability to give rise to morestemscellsor become other types ofcellswith more specialized function, explains Dr. Sejal Shah, board-certified dermatologist and RealSelf contributor in New York City. Plant stem cells serve similar functions, she says.

Both plant and human stem cells contain proteins and amino acids, adds Dr. Michele Green, board-certified dermatologist and RealSelf contributor in New York City. These signal the bodys cells to rejuvenate and may result in younger-looking skin, she says.

As mentioned above,stemcellscontain amino acids and peptides, which are skin care powerhouse ingredients for skin rejuvenation. These are the building blocks forcellrejuvenation, so over the past few years, there have been a variety of both animal- and plant-basedstemcellsin skin care products, explains Green. Stemcellsnaturally have antioxidant properties and they nourish skincellswhich promotescell turnover and increases collagen production.

This could result in fewer lines and wrinkles, improved skin texture and tone, and younger, better-looking skin, she says.

But keep in mind, its not actually living stem cells that youre seeing in your face cream, Shah notes. Most cell skin care products contain plant stem cells, and more specifically, stem cell extracts. Thats not necessarily a bad thing, though. She says these extracts are often rich in antioxidants and may provide growth factors to help renew and repair the skin. The extracts themselves can benefit the skin, but its not accurate to think that part of this type of product will then become a new skincell. Remember, plantcellscannot become humancells,and they are no longer living once they have been processed and added into skin care.

Dr. Eve Lupenko, board-certified dermatologist at Greenberg Cosmetic Surgery in New York City, is starting to use treatments containing plant-derived stem cells in her practice. The reason why we prefer to use plant stem cells is that you dont have to worry about transmitting human and animal diseases, she says. We are seeing plant-based stem cells in skin care products these days because they repair the skin on a cellular level (a much deeper level). Most regular skin care products dont penetrate into those areas of the actual skin cells.

The efficacy of stem cells in skin care depends on who you ask. Some dermatologists like Lupenko swear by them. Stem cells have the potential to repair skin cells, and they also protect your skin from external factors and create a more youthful look, she says. They go into the skins cellular level, and they are able to deliver moisture and reparative agents to where they need to go.

Others arent convinced about why exactly stem cells are suddenly buzzing in the skin care world. They can be rich in antioxidants and often contain hydrators and moisturizers, so they can be good for the skin, Shah says. But do I think they are more effective than non-stem cell products? Not necessarily.

Green sees the potential in using stem cells in conjunction with other treatments. The products work, however, you can improve the benefits dramatically with other procedures such as the Fraxel laser, thermage, injectable fillers, botox and PRP, a mix of micro-needling with platelet-rich plasma.

If youre interested in trying out stem cells, work with your dermatologist to determine which products would work best for your skin, recommends Lupenko. Its important to use them regularly if youd like to see results, she says.

And even though you might find some stem cell products derived from animals, Green recommends sticking with plant-based stem cells. Theres more research in their efficacy, she says.

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Stem Cells in Skin Care: What They Do and How They Work ...

Skin Stem Cells Comments Off on Stem Cells in Skin Care: What They Do and How They Work … | August 31st, 2020

Using a new type of stem cells made from ordinary skin cells, U.S. researchers said on Thursday they treated mice with sickle cell anemia, proving in principle that such cells could be used as a therapy.

U.S. and Japanese researchers last month reported they had reprogrammed human skin cells into behaving like embryonic stem cells, the bodys master cells. They call the cells induced pluripotent stem cells, or iPS cells for short.

Hanna and colleagues working in Rudolf Jaenischs lab at Whitehead Institute took skin cells from diseased mice and inserted four genes that reprogram the cells into becoming iPS cells.

Pluripotent or multipurpose cells, such as embryonic stem cells and the new cells, can morph into any type of cell in the human body.

The researchers then coaxed these mouse master cells into becoming blood-forming stem cells and substituted the faulty gene that causes sickle cell anemia with a working one.

When they transplanted these cells into the diseased mice, tests showed normal blood and kidney function, they report in Fridays issue of the journal Science.

The four genes needed to turn skin cells into master cells are delivered using a type of virus called a retrovirus.

Once they enter the genome, there is the danger that they can silence some genes that are important or they can activate some dangerous genes that shouldnt be activated, Hanna said.

Another obstacle is that one of the four genes used is c-Myc, which is known to cause cancer.

Hanna and colleagues got around that by removing the c-Myc gene after it had done its job of converting the skin cells into iPS cells. It is far from solving the problem, he said.

Scientists hope to use stem cells to treat a host of diseases like diabetes, Parkinsons disease and spinal injuries. And the new technique for making stem cells will make them easier to study.

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Stem cells made from skin cells treats sickle cell anemia ...

Skin Stem Cells Comments Off on Stem cells made from skin cells treats sickle cell anemia … | August 31st, 2020

The global war against the coronavirus pandemic continues to wage on while researchers and medical experts seek to find a cure for COVID-19 symptoms. While many believe this is here to stay for an indefinite period, others feel that this too, shall pass.

The number of confirmed cases and death rates only seem to darken our world with over 400,000 confirmed cases in New York, the death toll is now over 31,000, with over 233,000 confirmed cases in Florida, the death toll is now over 4,000, and with over 250,000 confirmed cases in Texas, the death toll is now over 3,000.

And here we are in July 2020 where you can simply add those statistics and drive to find a cure for COVID-19 to our to-do list in the war on cancer and other diseases that still have not seen a cure.

With Florida continuing to make headlines by the day, most recently with one family facing federal charges after allegedly marketing a toxic bleach solution as a cure for multiple ailments, including COVID-19, the timing for our society to come together to help find a cure is essential.

And no, were not kidding. The Florida family (Mark Grennon and his three sons) were charged Wednesday with conspiracy to defraud the United States, conspiracy to violate the Federal Food, Drug and Cosmetic Act, and criminal contempt, according to the Department of Justice.

As for the Florida community, one Tampa business has been conducting the first-in-human clinical study for cutaneous melanoma. Morphogenesis, a clinical-stage company developing novel cell and gene therapies has been making headlines after receiving FDA approval to expand its human clinical trials into two more types of cancer: Merkel cell carcinoma (MCC) and cutaneous squamous cell carcinoma (cSCC).

Using its ImmuneFx (IFx) cancer vaccine technology that initiates the power of the immune system on the destruction of tumor cells, Morphogenesis of Tampa will focus its newly FDA approved trials on understanding these two new cancers, which follows in the footsteps of successful human trials on cutaneous melanoma, conducted in cooperation with Moffitt Cancer Center in 2019.

Other MCC and cSCC clinical trial sites across the country include the University of Southern California, the University of Utah, the University of Colorado, and the Dana Farber / Harvard Cancer Center. So why so many trial sites?

Well, according to Morphogenesis CEO Dr. Patricia Lawman, clinical trials need patients, which to qualify, requires an individual having been diagnosed with advanced Merkel or cutaneous squamous cell carcinoma, and having failed or refused other therapies.

As a cell and gene company, the mission from the beginning was to learn from the body and use the bodys building blocks and communication systems to treat chronic disease. Morphogenesis, according to Lawman, was built to identify, isolate and proliferate stem cells and progenitor cells to treat diseases such as diabetes.

With the world united to change the way in which chronic diseases are treated by engaging the innate intelligence of the body, how do companies (on a local level) push for national change?

The ability to genetically modify stem cells to enhance functionality is one aspect of this, but in order to perform a biological function, the stem cells must differentiate into mature cells, e.g. hematopoietic stem cells differentiate into macrophages that perform phagocytic and antigen presentation functions and T cells that kill cancer cells or virally infected cells. Morphogenesis means the evolution of form, which connotes the change for stem cells to these functional cells capable of mitigating chronic disease.

And what this means for our bodies, according to Lawman, is that regardless of the species, our bodies have developed systems that maintain structure and function over a long period of time. When we need to control blood sugar, beta islet cells produce just enough insulin as needed.

Indeed with modern technology, you would think that this is a relatively easy process to control.

There is an exquisite feedback system that regulates this. When things go awry, our best solution has been to provide insulin through pumps that are controlled in part by constant glucose monitors. This one example of where modern technology has tried to solve a problem mimicking how the body works.

However, even providing insulin through a pump cant do what a pancreas can. When it comes to dealing with foreign invaders, the immune system is unequaled. No drug, small molecule or compound can eliminate an invader as well as a fully functional immune system. We can kill cancer cells (while not foreign, they are still invaders) with chemo and radiation, but given the proper assurance, the immune system can eliminate the invader and do it with fewer adverse effects. Almost always, the body performs healing functions better than a synthetic drug or compound.

The companys recent FDA approval to move forward with stage 2 of its clinical trials is a gigantic win for the companys mission. The ability to expand our proof of concept studies from a single skin cancer into other, quite different skin cancers under the same Investigational New Drug (IND) is the next step in the execution of our clinical development plan.

And that starts with Morphogenesis focus on easily accessible tumors.

Since our therapy can be used to treat virtually any type of cancer, we wanted to start out with easily accessible tumors that could be directly injected with our plasmid DNA. The safety data collected from the cutaneous melanoma, Merkel cell carcinoma and cutaneous squamous cell carcinoma Phase 1 trials is a Segway into a Phase 2 skin cancer basket trial testing IFx-Hu2.0 as a monotherapy and in combination with a checkpoint inhibitor.

But anytime there is discussion over stem cell research or breakthroughs in the war on cancer, of course comes naysayers and disbelievers.

One thing that Dr. Lawman has noticed is the bias within scientific circles.

In scientific circles, there has been a bias against simple solutions, including the assumption that to get efficient transfer of genetic material you need viral vectors for all applications. These vectors are complicated to manufacture and use and pose a certain amount of risk to the patients. Plasmid DNA or mRNA, on the other hand, are much safer and are a viable alternative to viruses.

As an example, we inject our plasmid DNA directly into a patients tumor. We get sufficient uptake and expression of our protein to initiate an immune cascade with the effect spreading to multiple tumor antigens. The use of a viral vector in this case would be an unnecessary complication and risk.

Now in todays landscape with COVID-19 putting more pressure on experts to find a cure, Morphogenesis, like any company, is similarly faced with logistical challenges and supply issues.

COVID-19 has certainly affected patient recruitment to our trials. Hopefully, ways will be developed for patients to receive treatment for their terminal diseases even if restrictions continue. Otherwise, the death rate for these patients will be much higher than COVIDs. The biggest challenge for us is the continual process of raising funds that all small biotechs face.

As for ImmuneFx, the companys newest vaccine, we got the exclusive.

Beyond the Phase 2 skin cancer trial, we will be opening trials for head and neck cancer, gastric cancers, cervical cancer and colorectal cancer. The value add here is that successful trial results in multiple types of cancer will substantiate the efficacy and expand our label claims.

But with new products and solutions, come criticism. Lawman added that the one thing that is not usually discussed in such conversations is the importance of the safety profile of a new product.

Some of the new cellular immunotherapies not only come with a hefty price tag, the cost of treating the adverse side effects caused by the therapies can be as much as double the cost of the therapy itself (up to $1.5M total). Some of the newer gene therapies can have a price tag of up to $2M per treatment.

Not only can our plasmid DNA be cost effectively manufactured, it is causing minimal side effects, i.e. what we saw in hundreds of companion animals with naturally occurring cancers is being born out in human patients. Both of these cost saving factors means that ultimately, millions of people will have access to cancer treatment who otherwise would have none.

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Why The FDA's Recent Approval Of New Vaccine Is A Gigantic Win In The War On Cancer - Innovation & Tech Today

Skin Stem Cells Comments Off on Why The FDA’s Recent Approval Of New Vaccine Is A Gigantic Win In The War On Cancer – Innovation & Tech Today | August 31st, 2020

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

The regional analysis covers:

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Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Scope and Opportunities Analysis 2017 2025 - StartupNG

Cardiac Stem Cells Comments Off on Stem Cell Therapy Market Scope and Opportunities Analysis 2017 2025 – StartupNG | August 31st, 2020

The global Stem Cell-Derived Cells market study presents an all in all compilation of the historical, current and future outlook of the market as well as the factors responsible for such a growth. With SWOT analysis, the business study highlights the strengths, weaknesses, opportunities and threats of each Stem Cell-Derived Cells market player in a comprehensive way. Further, the Stem Cell-Derived Cells market report emphasizes the adoption pattern of the Stem Cell-Derived Cells across various industries.

The Stem Cell-Derived Cells market report examines the operating pattern of each player new product launches, partnerships, and acquisitions has been examined in detail.

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key players in stem cell-derived cells market are focused on generating high-end quality cardiomyocytes as well as hepatocytes that enables end use facilities to easily obtain ready-made iPSC-derived cells. As the stem cell-derived cells market registers a robust growth due to rapid adoption in stem cellderived cells therapy products, there is a relative need for regulatory guidelines that need to be maintained to assist designing of scientifically comprehensive preclinical studies. The stem cell-derived cells obtained from human induced pluripotent stem cells (iPS) are initially dissociated into a single-cell suspension and later frozen in vials. The commercially available stem cell-derived cell kits contain a vial of stem cell-derived cells, a bottle of thawing base and culture base.

The increasing approval for new stem cell-derived cells by the FDA across the globe is projected to propel stem cell-derived cells market revenue growth over the forecast years. With low entry barriers, a rise in number of companies has been registered that specializes in offering high end quality human tissue for research purpose to obtain human induced pluripotent stem cells (iPS) derived cells. The increase in product commercialization activities for stem cell-derived cells by leading manufacturers such as Takara Bio Inc. With the increasing rise in development of stem cell based therapies, the number of stem cell-derived cells under development or due for FDA approval is anticipated to increase, thereby estimating to be the most prominent factor driving the growth of stem cell-derived cells market. However, high costs associated with the development of stem cell-derived cells using complete culture systems is restraining the revenue growth in stem cell-derived cells market.

The global Stem cell-derived cells market is segmented on basis of product type, material type, application type, end user and geographic region:

Segmentation by Product Type

Segmentation by End User

The stem cell-derived cells market is categorized based on product type and end user. Based on product type, the stem cell-derived cells are classified into two major types stem cell-derived cell kits and accessories. Among these stem cell-derived cell kits, stem cell-derived hepatocytes kits are the most preferred stem cell-derived cells product type. On the basis of product type, stem cell-derived cardiomyocytes kits segment is projected to expand its growth at a significant CAGR over the forecast years on the account of more demand from the end use segments. However, the stem cell-derived definitive endoderm cell kits segment is projected to remain the second most lucrative revenue share segment in stem cell-derived cells market. Biotechnology and pharmaceutical companies followed by research and academic institutions is expected to register substantial revenue growth rate during the forecast period.

North America and Europe cumulatively are projected to remain most lucrative regions and register significant market revenue share in global stem cell-derived cells market due to the increased patient pool in the regions with increasing adoption for stem cell based therapies. The launch of new stem cell-derived cells kits and accessories on FDA approval for the U.S. market allows North America to capture significant revenue share in stem cell-derived cells market. Asian countries due to strong funding in research and development are entirely focused on production of stem cell-derived cells thereby aiding South Asian and East Asian countries to grow at a robust CAGR over the forecast period.

Some of the major key manufacturers involved in global stem cell-derived cells market are Takara Bio Inc., Viacyte, Inc. and others.

The report covers exhaustive analysis on:

Regional analysis includes

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The Stem Cell-Derived Cells market report offers a plethora of insights which include:

The Stem Cell-Derived Cells market report answers important questions which include:

The Stem Cell-Derived Cells market report considers the following years to predict the market growth:

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Stem Cell-Derived Cells Market Forecast to 2025: Global Industry Analysis by Top Players, Types, Key Regions and Applications - The Scarlet

IPS Cell Therapy Comments Off on Stem Cell-Derived Cells Market Forecast to 2025: Global Industry Analysis by Top Players, Types, Key Regions and Applications – The Scarlet | August 30th, 2020