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Mesenchymal stem cells in cardiac regeneration: a detailed …

By daniellenierenberg

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Mesenchymal stem cells in cardiac regeneration: a detailed ...

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James T. Willerson, Revered Clinician, Editor, and Mentor, Dies at 81 – TCTMD

By daniellenierenberg

Esteemed cardiologist James T. Willerson, MD, of the Texas Heart Institute, who pioneered research in unstable atherosclerotic plaques and was the longest-serving editor of Circulation, died after a long illness on September 16, 2020, at age 81.

It's very easy to find his scientific contributions, which have been countless, said longtime friend and colleague Mohammad Madjid, MD (University of Texas Health Science Center, Houston). But if you knew him and saw how he worked, the thing that really stood out was how compassionate and genuine he was with his patients. He had an amazing rapport with them, and they knew he meant it when he said he was only one phone call away from them, 24-7, Madjid added. Over all the years that I knew him, I never saw him getting angry. He had a cool, gentle manner even under the most serious of circumstances.

Paul Ridker, MD (Harvard Medical School, Boston, MA), told TCTMD Willerson will be greatly missed.

Jim Willersons reach and influence were simply exceptional, he said. Early in my career, Jim reached out and was both supportive and inspirational. Over the years he became a friend and treasured research colleague.

Renu Virmani, MD (CVPath Institute, Gaithersburg, MD), said she got to know Willerson through his passion to advance the field of atherosclerosis and his desire to figure out how to predict future cardiac events so as to treat them before catastrophe occurred.

"While editor of Circulation, he encouraged everyone involved in research in this area, and I was one of the lucky ones whose career benefited from his passion, his curiosity, and his mentorship. I will always remember him as among the kindest and most humble leaders in our field," she said in an email. "His foresight did so much to advance knowledge in that field and I am deeply saddened by his passing."

In 2005, Willerson was the recipient of the TCT Career Achievement Award. Jim Willerson was a towering figure in medicine, Martin B. Leon, MD (NewYork-Presbyterian/Columbia University Irving Medical Center, New York, NY), TCTs founder and director, told TCTMD. He had a legendary work ethic, set new standards as editor-in-chief of Circulation, and always reverted to his patient-centered origins as a revered clinician. Jim was soft-spoken and extremely humble, which belied his raging intellect, thirst for knowledge, and commitment to excellence. He will be remembered as a true giant in cardiology, setting the stage for the modern era.

Gregg W. Stone, MD (Icahn School of Medicine at Mount Sinai, New York, NY), also a TCT director, called Willerson one of the true giants of medicine, as well as the consummate scientist, educator, editor, academician and caregiver.

He was also a warm person, inherently humble, but knew when to be outspoken and motivated generations of cardiologists. He will be greatly missed but always remembered, Stone remarked.

A Texas-Sized Life

Willerson was born on the edge of the Texas Hill Country in Lampasas to parents who were both physicians. He attended school in San Antonio and Austin before receiving his medical degree from Baylor College of Medicine in Houston. A championship swimmer in his college days, Willerson has a swimming scholarship named in his honor at his alma mater, the University of Texas at Austin.

In an interview published in 2018 in the European Heart Journal, he explained that a meeting arranged by his mother when he was just 14 years old, with the renowned cardiovascular surgeon Denton Cooley, MD, changed the arc of his life. Rather than a quick hello, Willerson recalled that the two spent 30 minutes speaking about Willersons interest in becoming a physician. The meeting was the start of an enduring friendship and collaboration with Cooley, who founded the Texas Heart Institute (THI) and performed the first successful artificial heart transplantation there in 1969. When Cooley stepped aside as president of THI at age 86, he chose Willerson to take the job. Willerson continued on, serving as president emeritus until his death.

He was the best role model that anyone could have, and the most lovable human you could ever want to be around. Mohammad Madjid

For many years, Madjid said, Willerson and Cooley worked in offices next-door to each other, remaining close until Cooleys death in 2016.

Throughout his long career, Willerson pioneered research on the detection and treatment of vulnerable atherosclerotic plaques, as well as genes and abnormal proteins. As a result of his research, he was awarded 15 patents, and his institution became the site of the first US Food and Drug Administration-approved trial of human stem cells to treat ischemic cardiomyopathies and congestive HF. Over his career, he published an estimated 1,000 scientific papers and wrote one of the first textbooks on nuclear cardiology.

Juan Granada, MD, CEO of the Cardiovascular Research Foundation (CRF), who spent time as a fellow at THI and worked closely with Willerson, said they shared an interest in vulnerable plaque research and vascular imaging.

He was very entrepreneurial, very innovative, and one of the hardest working people that I ever met in my life, Granada noted. He recalled that during Willersons long tenure as editor of Circulation, he would often personally contact authors to sort through problems that cropped up during the review process.

This is essentially unheard of nowadays, but he would actually call you on the phone and say, Hey, I got this comment. Lets talk it through. He was amazing and unique in what he did, and he was a beautiful, caring person on top of it, Granada added.

To TCTMD, Madjid said of his mentor, He had my back through everything. When I was down, he was there. When I needed help or to talk, he was always there. He was the best role model that anyone could have, and the most lovable human you could ever want to be around.

Following the Texas Heart Institutes announcement of Willersons death, colleagues and friends took to Twitter to share their memories.

Photo Credit: Mohammad Madjid

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Merck Presents Promising New Data for Three Investigational Medicines From Diverse and Expansive Oncology Pipeline at ESMO Virtual Congress 2020 – The…

By daniellenierenberg

KENILWORTH, N.J.--(BUSINESS WIRE)--Sep 20, 2020--

Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of new data for three investigational medicines in Mercks diverse and expansive oncology pipeline: vibostolimab (MK-7684), an anti-TIGIT therapy; MK-4830, a first-in-class anti-ILT4 therapy; and MK-6482, an oral HIF-2 inhibitor. Data from cohort expansions of a Phase 1b trial evaluating vibostolimab, as monotherapy and in combination with KEYTRUDA, Mercks anti-PD-1 therapy, in patients with metastatic non-small cell lung cancer (NSCLC; Abstract #1410P and Abstract #1400P), and first-time Phase 1 data for MK-4830 in patients with advanced solid tumors (Abstract #524O), demonstrated acceptable safety profiles for these two investigational medicines and early signals of anti-tumor activity. Additionally, late-breaking Phase 2 data for MK-6482 showed anti-tumor responses in von Hippel-Lindau (VHL) disease patients with clear cell renal cell carcinoma (RCC) and other tumors (Abstract #LBA26).

The new data for these three investigational medicines are encouraging and highlight continued momentum in our rapidly expanding oncology pipeline, Dr. Eric H. Rubin, senior vice president, early-stage development, clinical oncology, Merck Research Laboratories. Over the past five years, KEYTRUDA has become foundational in the treatment of certain advanced cancers. Our broad oncology portfolio and promising pipeline candidates are a testament to our commitment to bring forward innovative new medicines to address unmet medical needs in cancer care.

Vibostolimab (Anti-TIGIT Therapy): Early Findings in Metastatic NSCLC (Abstract #1410P and Abstract #1400P)

Vibostolimab in combination with KEYTRUDA was evaluated in patients with metastatic NSCLC who had not previously received antiPD-1/PD-L1 therapy, but the majority of whom had received > 1 prior lines of therapy (73%, n=30/41) in Abstract #1410P. In Part B of the first-in-human, open-label, Phase 1 trial ( NCT02964013 ) all patients received vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included objective response rate (ORR), duration of response (DOR) and progression-free survival (PFS) based on investigator review per RECIST v1.1. In this anti-PD-1/PD-L1 nave study, vibostolimab in combination with KEYTRUDA had a manageable safety profile and demonstrated promising anti-tumor activity. Treatment-related adverse events (TRAEs) with vibostolimab in combination with KEYTRUDA occurred in 34 patients (83%). The most frequent TRAEs (20%) were pruritus (34%), hypoalbuminemia (29%) and pyrexia (20%). Grade 3-5 TRAEs occurred in six patients (15%). No deaths due to TRAEs occurred. Across all patients enrolled, treatment with vibostolimab in combination with KEYTRUDA demonstrated an ORR of 29% (95% CI, 16-46) and median PFS was 5.4 months (95% CI, 2.1-8.2). The median DOR was not reached (range, 4 to 17+ months). Among patients whose tumors express PD-L1 (tumor proportion score [TPS] 1%) (n=13), the ORR was 46% (95% CI, 19-75) and median PFS was 8.4 months (95% CI, 3.9-10.2). Among patients whose tumors express PD-L1 (TPS <1%) (n=12), the ORR was 25% (95% CI, 6-57), and median PFS was 4.1 months (95% CI, 1.9-not reached [NR]). PD-L1 status was not available for 16 patients. Median follow-up for the study was 11 months (range, 7 to 18).

Additional data from a separate cohort of the same Phase 1b trial evaluated vibostolimab as monotherapy (n=41) and in combination with KEYTRUDA (n=38) in patients with metastatic NSCLC whose disease progressed on prior anti-PD-1/PD-L1 therapy (Abstract #1400P). In the study, 78% of patients had received > 2 lines of prior therapy. In the study, patients received vibostolimab monotherapy (200 or 210 mg) or vibostolimab (200 or 210 mg) in combination with KEYTRUDA (200 mg) on Day 1 of each three-week cycle for up to 35 cycles. The primary endpoints of the study were safety and tolerability. Secondary endpoints included ORR and DOR. Vibostolimab as monotherapy or in combination with KEYTRUDA had a manageable safety profile and demonstrated modest anti-tumor activity in patients whose disease was refractory to PD-1/PD-L1 inhibition, most of whom had previously received several lines of therapy for advanced disease prior to enrollment. Grade 3-5 TRAEs occurred in 15% of patients receiving vibostolimab monotherapy and 13% of patients receiving vibostolimab in combination with KEYTRUDA. The most common TRAEs (10% in either arm) were pruritus, fatigue, rash, arthralgia and decreased appetite. One patient died due to treatment-related pneumonitis in the vibostolimab and KEYTRUDA combination arm. The ORR was 7% (95% CI, 2-20) with vibostolimab monotherapy and 5% (95% CI, <1-18) with vibostolimab in combination with KEYTRUDA. The median DOR was 9 months (range, 9 to 9) with vibostolimab monotherapy and 13 months (range, 4+ to 13) with vibostolimab in combination with KEYTRUDA.

Data from these cohort expansion studies are encouraging and support the continued development of vibostolimab, which is being evaluated alone and in combination with KEYTRUDA across multiple solid tumors, including NSCLC and melanoma. In the ongoing Phase 2 KEYNOTE-U01 umbrella study ( NCT04165798 ), substudy KEYNOTE-01A ( NCT04165070 ) is evaluating vibostolimab in combination with KEYTRUDA plus chemotherapy for the first-line treatment of patients with advanced NSCLC who had not received prior treatment with an anti-PD-1/PD-L1. Merck plans to initiate a Phase 3 study of vibostolimab in NSCLC in the first half of 2021. Ongoing trials in melanoma include the Phase 1/2 KEYNOTE-U02 umbrella study comprised of three substudies evaluating vibostolimab in combination with KEYTRUDA across treatment settings (substudy 02A: NCT04305041, substudy 02B: NCT04305054 and substudy 02C: NCT04303169 ).

MK-4830 (Anti-ILT4 Therapy): Initial Results in Advanced Solid Tumors (Abstract #524O)

In this first-in-human Phase 1, open-label, multi-arm, multi-center, dose escalation study ( NCT03564691 ), MK-4830, Mercks first-in-class anti-ILT4 therapy, was evaluated as monotherapy (n=50) and in combination with KEYTRUDA (n=34) in patients with advanced solid tumors. The majority of patients enrolled in the study (51%) had received three or more prior lines of therapy. MK-4830 was administered intravenously at escalating doses every three weeks alone or in combination with KEYTRUDA (200 mg every three weeks). The primary endpoints of the dose escalation part of the study were safety and tolerability; Pharmacokinetics was a secondary endpoint, and exploratory objectives included ORR per RECIST v1.1, evaluation of receptor occupancy and immune correlates of response in blood and tumor.

Findings showed that MK-4830 as monotherapy and in combination with KEYTRUDA had an acceptable safety profile and demonstrated dose-related evidence of target engagement in patients with advanced solid tumors. No dose-limiting toxicities were observed; the maximum-tolerated dose was not reached. Any-grade adverse events were consistent with those associated with KEYTRUDA. Treatment-related AEs occurred in 54% (n=28/52) of patients who received MK-4830 in combination with KEYTRUDA and 48% (n=24/50) of patients who received MK-4830 monotherapy; the majority were Grade 1 and 2. Preliminary efficacy data showed an ORR of 24% (n=8/34) in patients who received MK-4830 in combination with KEYTRUDA. All responses occurred in heavily pretreated patients, including five who had progressed on prior anti-PD-1 therapy (n=5/11). Some patients received more than one year of treatment, and treatment is ongoing in several patients.

These early data support the continued development of MK-4830 in combination with KEYTRUDA in patients with advanced solid tumors. Expansion cohorts of this study include pancreatic adenocarcinoma, glioblastoma, head and neck squamous cell carcinoma (recurrent or metastatic; PD-L1 positive), advanced NSCLC and gastric cancer.

MK-6482 (HIF-2 Inhibitor): Results in VHL-Associated RCC and Non-RCC Tumors (Abstract #LBA26)

In this Phase 2, open-label, single-arm trial, MK-6482 was evaluated for the treatment of VHL-associated RCC ( NCT03401788 ). New data include findings for MK-6482 in VHL patients with non-RCC tumors and updated data in VHL patients with RCC. First-time data in VHL-associated RCC were presented in the virtual scientific program of the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. The study enrolled adult patients with a pathogenic germline VHL variation, measurable localized or non-metastatic RCC, no prior systemic anti-cancer therapy, and Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1. Patients received MK-6482 120 mg orally once daily until disease progression, unacceptable toxicity, or investigators or patients decision to withdraw. The primary endpoint was ORR of VHL-associated RCC tumors per RECIST v1.1 by independent radiology review. Secondary endpoints included DOR, time to response, PFS, efficacy in non-RCC tumors, and safety and tolerability.

Promising clinical activity continues to be observed with MK-6482 in treatment-nave patients with VHL-associated RCC. Among 61 patients, results showed a confirmed ORR of 36.1% (95% CI, 24.2-49.4); all responses were partial responses, and 38% of patients had stable disease. The median time to response was 31.1 weeks (range, 11.9 to 62.3), and median DOR was not yet reached (range, 11.9 to 62.3 weeks). Additionally, 91.8% (n=56) of patients had a decrease in size of target lesions. Median PFS has not been reached, and the PFS rate at 52 weeks was 98.3%. Median duration of treatment was 68.7 weeks (range, 18.3 to 104.7), and 91.8% of patients were still on therapy after a minimum follow-up of 60 weeks.

In patients with non-RCC tumors, results in those with pancreatic lesions (n=61) showed a confirmed ORR of 63.9% (95% CI, 50.6-75.8), with four complete responses and 35 partial responses. Additionally, 34.4% had stable disease. In those with central nervous system (CNS) hemangioblastoma (n=43), results showed a confirmed ORR of 30.2% (95% CI, 17.2-46.1), with five complete responses and eight partial responses. Additionally, 65.1% had stable disease. In patients with retinal lesions (n=16), 93.8% of patients had improved or stable response.

In this Phase 2 study, TRAEs occurred in 98.4% of patients, and there were no Grade 4-5 TRAEs. The most common all-cause adverse events (20%) were anemia (90.2%), fatigue (60.7%), headache (37.7%), dizziness (36.1%) and nausea (31.1%). Grade 3 all-cause adverse events included anemia (6.6%), fatigue (4.9%) and dyspnea (1.6%). One patient discontinued treatment due to a TRAE (Grade 1 dizziness).

As announced, data spanning more than 15 types of cancer will be presented from Mercks broad oncology portfolio and investigational pipeline at the congress. A compendium of presentations and posters of Merck-led studies is available here. Follow Merck on Twitter via @Merck and keep up to date with ESMO news and updates by using the hashtag #ESMO20.

About Vibostolimab

Vibostolimab is an anti-TIGIT therapy discovered and developed by Merck. Vibostolimab binds to TIGIT and blocks the interaction between TIGIT and its ligands (CD112 and CD155), thereby activating T lymphocytes which help to destroy tumor cells. The effect of combining KEYTRUDA with vibostolimab blocking both the TIGIT and PD-1 pathways simultaneously is currently being evaluated across multiple solid tumors, including NSCLC and melanoma.

About MK-4830

MK-4830 is a novel antibody directed against the inhibitory immune checkpoint receptor immunoglobulin-like transcript 4 (ILT4). Unlike current T cell-targeted antibodies (e.g., anti-PD1, anti-CTLA-4), anti-ILT4 is believed to attenuate immunosuppression imposed by tolerogenic myeloid cells in the tumor microenvironment. MK-4830 is currently being evaluated alone and in combination with KEYTRUDA across multiple solid tumors as part of ongoing Phase 1 and 2 trials.

About MK-6482

MK-6482 is an investigational, novel, potent, selective, oral HIF-2 inhibitor that is currently being evaluated in a Phase 3 trial in advanced RCC ( NCT04195750 ), a Phase 2 trial in VHL-associated RCC ( NCT03401788 ), and a Phase 1/2 dose-escalation and dose-expansion trial in advanced solid tumors, including advanced RCC ( NCT02974738 ). Proteins known as hypoxia-inducible factors, including HIF-2, can accumulate in patients when VHL, a tumor-suppressor protein, is inactivated. The accumulation of HIF-2 can lead to the formation of both benign and malignant tumors. This inactivation of VHL has been observed in more than 90% of RCC tumors. Research into VHL biology that led to the discovery of HIF-2 was awarded the Nobel Prize in Physiology or Medicine in 2019.

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).

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 (pembrolizumab)

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.

Immune-Mediated Skin Reactions

Immune-mediated rashes, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN) (some cases with fatal outcome), exfoliative dermatitis, and bullous pemphigoid, can occur. Monitor patients for suspected severe skin reactions and based on the severity of the adverse reaction, withhold or permanently discontinue KEYTRUDA and administer corticosteroids. For signs or symptoms of SJS or TEN, withhold KEYTRUDA and refer the patient for specialized care for assessment and treatment. If SJS or TEN is confirmed, permanently discontinue KEYTRUDA.

Other Immune-Mediated Adverse Reactions

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue in patients receiving KEYTRUDA and may also occur after discontinuation of treatment. For suspected immune-mediated adverse reactions, ensure adequate evaluation to confirm etiology or exclude other causes. Based on the severity of the adverse reaction, withhold KEYTRUDA and administer corticosteroids. Upon improvement to Grade 1 or less, initiate corticosteroid taper and continue to taper over at least 1 month. Based on limited data from clinical studies in patients whose immune-related adverse reactions could not be controlled with corticosteroid use, administration of other systemic immunosuppressants can be considered. Resume KEYTRUDA when the adverse reaction remains at Grade 1 or less following corticosteroid taper. Permanently discontinue KEYTRUDA for any Grade 3 immune-mediated adverse reaction that recurs and for any life-threatening immune-mediated adverse reaction.

The following clinically significant immune-mediated adverse reactions occurred in less than 1% (unless otherwise indicated) of 2799 patients: arthritis (1.5%), uveitis, myositis, Guillain-Barr syndrome, myasthenia gravis, vasculitis, pancreatitis, hemolytic anemia, sarcoidosis, and encephalitis. In addition, myelitis and myocarditis were reported in other clinical trials, including classical Hodgkin lymphoma, and postmarketing use.

Treatment with KEYTRUDA may increase the risk of rejection in solid organ transplant recipients. Consider the benefit of treatment vs the risk of possible organ rejection in these patients.

Infusion-Related Reactions

KEYTRUDA can cause severe or life-threatening infusion-related reactions, including hypersensitivity and anaphylaxis, which have been reported in 0.2% (6/2799) of patients. Monitor patients for signs and symptoms of infusion-related reactions. For Grade 3 or 4 reactions, stop infusion and permanently discontinue KEYTRUDA.

Complications of Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Immune-mediated complications, including fatal events, occurred in patients who underwent allogeneic HSCT after treatment with KEYTRUDA. Of 23 patients with cHL who proceeded to allogeneic HSCT after KEYTRUDA, 6 (26%) developed graft-versus-host disease (GVHD) (1 fatal case) and 2 (9%) developed severe hepatic veno-occlusive disease (VOD) after reduced-intensity conditioning (1 fatal case). Cases of fatal hyperacute GVHD after allogeneic HSCT have also been reported in patients with lymphoma who received a PD-1 receptorblocking antibody before transplantation. Follow patients closely for early evidence of transplant-related complications such as hyperacute graft-versus-host disease (GVHD), Grade 3 to 4 acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease (VOD), and other immune-mediated adverse reactions.

In patients with a history of allogeneic HSCT, acute GVHD (including fatal GVHD) has been reported after treatment with KEYTRUDA. Patients who experienced GVHD after their transplant procedure may be at increased risk for GVHD after KEYTRUDA. Consider the benefit of KEYTRUDA vs the risk of GVHD in these patients.

Increased Mortality in Patients With Multiple Myeloma

In trials in patients with multiple myeloma, the addition of KEYTRUDA to a thalidomide analogue plus dexamethasone resulted in increased mortality. Treatment of these patients with a PD-1 or PD-L1 blocking antibody in this combination is not recommended outside of controlled trials.

Embryofetal Toxicity

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Merck Presents Promising New Data for Three Investigational Medicines From Diverse and Expansive Oncology Pipeline at ESMO Virtual Congress 2020 - The...

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Regenerative Therapy by Dr. Roshni Patel on Better CT – Farmington, CT – Patch.com

By daniellenierenberg

When youre in pain, its important to find effective, long-lasting solutions that can provide short recovery periods. This is what regenerative medicine offers. Over the past decade, there has been a growing field of medicine that utilizes the bodys own healing capabilities using platelet-rich plasma and mesenchymal stem cells (MSCs). This growing field is labeled as regenerative medicine. Regenerative therapies focus on healing and help regrow damaged tissue naturally. Regenerative injection therapy is used to provide relief to musculoskeletal injuries that involve damage to ligaments, tendons, cartilage, joints, and discs.

Watch video of PRP:

PRP therapy on Better CT

PRP is safeas we are using what your body naturally produces, concentrating the desired critical components and transplanting them into the affected area for effective tissue regeneration and healing. There is no risk of rejection and very minimal overall procedural risk.

FDA regulations do not allow for the cloning of stem cells or growing them in a lab. Also, stem cells derived from fat cells are not approved by the FDA as it does not allow for manipulation. This leaves us to another rich stem cell source in our body which is bone marrow. Stem cells exist in our bodies and are rudimentary cells that can differentiate into other cells.

Think of bone marrow stem cells as the mother cell that is responsible for producing new blood cells. Bone marrow contains hundreds of growth factors and is often used for severe degenerative conditions or where PRP therapy may not be sufficient to provide the growth factors needed to provide relief.

Lastly, there are many offshoot therapies that use biologics derived from placental tissue or blood cord. These biologics are sometimes marketed as Stem cells but are not stem cells and contain zero viable cells. What they contain are growth factors that can also aid when combined with PRP or Stem Cells derived from your own body.

MSCs and PRPmay be used to target a number of conditions that could benefit from their healing and regenerative qualities. Especially when considering chronic pain, alternative solutions may be necessary if it has been difficult to find relief. Along with generalized joint pain, MSCs and PRPmay be used to target:

With so many options for joint pain out there, you may be wondering what benefits choosing stem cell therapy provides. Overall, because mesenchymal stem cell therapy utilizes biologic material harvested directly from the patients body, the general benefits include minimal risk, minimal recovery time, and minimal worry:

Avoid surgery and its many complications and risks: Stem cell therapy is a minimally invasive, non-surgical procedure.

Minimal post-procedural recovery time: One of the most time-consuming factors of any injury is not always the treatment itself, but actually the recovery time. With stem cell therapy, recovery time is minimal.

No risk of rejection: Due to using biologics extracted from the patient, there is no risk of rejection.

No communicable disease transmission: As the cells originate within your own body, there is no risk of spreading disease from or to another person.

If you are suffering from joint pain, back pain, or a debilitating condition like osteoarthritis, it is important to consider all of your available options. Our elite team of professionals can determine if you are the right candidate for MSCs. If youre interested in learning more, contact us today.

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Improved Induction Therapies Could Eliminate the Need for Transplant in Myeloma – OncLive

By daniellenierenberg

As induction therapies continue to improve the depth of response (DOR) in patients with multiple myeloma, it may be possible to eliminate the need forautologous stem cell transplant (ASCT) in this population, provided that deep responses with up-front therapy can be achieved, according to Jeffrey Wolf, MD.

There are a lot of reasons I would like to get rid ofautologous stem cell transplants, Wolf said. Newer drugs and newer regimens are going to allow us to get there, [provided] we [conduct] the right studies.

There has been notable growth of induction therapies within the myeloma space, particularly with regard to triplet regimens, such as lenalidomide (Revlimid), bortezomib (Velcade), and dexamethasone (RVd), as well as carfilzomib (Kyprolis), lenalidomide, and dexamethasone (KRd). Daratumumab (Darzalex) is also making great progress by quickly moving to the frontline setting for patients who are transplant ineligible, as well as for older patients who appear to tolerate the agent well, Wolf explained.

Its possible that as our induction therapies improve over the next few years, we may be able to eliminateautologous stem cell transplantation as a form ofconsolidationif we [can] get deep responses, such as minimal residual disease (MRD) [negativity] with just our initial induction therapy, said Wolf.

In an interview with OncLive, Wolf, a clinical professor within the Department of Medicine at University of California, San Francisco (UCSF) and director of the Myeloma Program at the UCSF Helen Diller Family Comprehensive Cancer Center, discusses treatment options for patients with myeloma, in addition to how MRD can be used to inform clinical decisions and improve patient outcomes.

OncLive: Could you discuss the evolution of induction therapy in multiple myeloma?

Wolf: Induction therapy for myeloma has evolved tremendously over the past few years, [especially] triplet induction [regimens, such as] RVd or KRd,based on recent studies. Daratumumab is certainly making a rapid move to be included in [frontline] therapy, especially in patients who are not eligible for transplant. It seems [that if the agent is] appropriate for them, it could be appropriate for younger patients, as well, but we dont have an FDA approval [in younger patients yet].

The goal [of treatment] is DOR, [which] is measured byMRD.

What are some of the strategies that are being used for transplant-eligible and -ineligible patients with newly diagnosed disease?

One of the main studies I presented [during my talk] was the ENDURANCE trial, which was just presented at the 2020 American Society of Clinical Onccology Virtual Meeting. The trial was what we thought of as somewhat of a flawed study that [claimed] RVd and KRd were equivalent for progression-freesurvival (PFS) [in transplant-eligible patients]. The problem is that most patients move on to transplant. What we really should have been looking at was KRd plus transplant versus RVd plus transplant. [The studys design] eliminated patients from the analysis when they underwent transplant.

In the transplant-ineligible setting, there are a lot more studies to refer to, including the studies that moved daratumumab to the frontline setting. Initially, we learned that maintenance lenalidomide was necessary even in patients who are not posttransplant. Another study showed thatdaratumumab added to bortezomib, melphalan, and prednisone(VMP) really improved PFS and overall survival (OS). Of course, [there is also the study that evaluated]daratumumab plus lenalidomide and dexamethasone (Rd) versusRd, [whereby] daratumumab adds tremendous depth and durability.

This morning I put 2 older patients on that regimen. They tolerateddaratumumab quite well and can get a DOR that is equivalent to that of a patient who undergoes transplant.

How are you navigating among the agents that are currently available in practice?

It seems complicated because there are so many options, but it tends to sort itself out by circumstance. For example, this morning I saw a transplant-ineligible patient who didnt getMedicare Part D and, therefore, I couldnt give them oral therapies such aslenalidomide. Their referring doctor gave them cyclophosphamide, bortezomib, and dexamethasone (CyBorD), which is all [intravenous]. This morning I decided to switch them tosubcutaneous daratumumab, bortezomib,dexamethasone.

Most of these regimens will give you the same responses. I often start with preexisting conditions to decide which drugs I eliminate and which drugs Im going to use instead.

What is the role of transplant in this space right now? Will transplant retain its role in future?

I started out as a transplanter 40 years ago, so its hard to say this, but Ive been thinking for the past decade that were on the verge of getting rid ofautologous stem cell transplant from myeloma. If our induction therapies are so effective, we may be able to eliminate transplant. Id like to see us conduct trials, such as the MASTER trial, led by Luciano Costa, MD, PhD, of the University of Alabamas Birmingham School of Medicine, in which patients who achieve MRD [negativity] with induction therapy do not proceed to transplant. Were going to have to do those kinds of studies to eliminate transplant. Its a fairly primitive kind of therapy in that we give high-dose therapy to wipe out as much myeloma as we can, and in doing so wipe out vulnerable bone marrow. Then, we have to [transplant] frozen stem cells from the patient. [The alkylator] leads to increased risk of secondary malignancies. Patients lose their hair, they get sick for 2 or 3 months, and theyre immunocompromised, which is not a good thing to be these days.

How might MRD be used to optimize patient outcomes?

In the world of myeloma, experts are divided over whether to use MRD to make decisions. I happen to be in the group [in favor of MRD]. Its no different than usingmonoclonal spike (m spike) orlight chain measurements to make decisions. Were already using MRD in chronic lymphocytic leukemia andacute lymphocytic leukemia to make decisions. The only restriction in myeloma is that, so far, weve only been able to [evaluate MRD with] bone marrow and not blood. If we can start measuring MRD in myeloma [through] blood, it would be as commonly used as light chain or m spike measurements to make these decisions. Itll help us immeasurably because most of the time were getting patients into complete remission (CR)which it really isnt CRand then we keep them on regimens for maintenance.

For example, when we dont know what were accomplishing, [its worth asking], Are patients getting better? Are patients staying the same? Is the MRD going up while were treating patients with drugs that clearly arent working? Should we be switching therapies? For patients who are MRD [negative] year after year, is there any reason why we have them on these therapies that are so costly and have so many adverse effects (AEs) and secondary malignancies? There are all kinds of reasons as to why we should be using MRD for measurement. I would argue that the only reason why we arent using MRD is because we have to [evaluate] it in bone marrow, which is a little more uncomfortable compared with blood, and maybe because the studies havent been completed yet. Its only a matter of 1 or 2 years before we will be using MRD to make clinical decisions. In terms of frontline therapies, using MRD might allow us to [avoid] transplant or indicate when weve given enough treatment and is time to move to maintenance. There a lot of possibilities to using MRD instead of just historically saying, this is how we do it.

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New research connects the hormones we’re born with to lifetime risk for immunological diseases – MSUToday

By daniellenierenberg

Differences in biological sex can dictate lifelong disease patterns, says a new study by Michigan State University researchers that links connections between specific hormones present before and after birth with immune response and lifelong immunological disease development.

Published in the most recent edition of the Proceedings of the National Academy of Sciences, the study answers questions about why females are at increased risk for common diseases that involve or target the immune system like asthma, allergies, migraines and irritable bowel syndrome. The findings by Adam Moeser, Emily Mackey and Cynthia Jordan also open the door for new therapies and preventatives

This research shows that its our perinatal hormones, not our adult sex hormones, that have a greater influence on our risk of developing mast cell-associated disorders throughout the lifespan, says Moeser, Matilda R. Wilson Endowed Chair, professor in the Department of Large Animal Clinical Sciences and the studys principle investigator. A better understanding of how perinatal sex hormones shape lifelong mast cell activity could lead to sex-specific preventatives and therapies for mast cell-associated diseases.

Mast cells are white blood cells that play beneficial roles in the body. They orchestrate the first line of defense against infections and toxin exposure and play an important role in wound healing, according to the study, Perinatal Androgens Organize Sex Differences in Mast Cells and Attenuate Anaphylaxis Severity into Adulthood.

However, when mast cells become overreactive, they can initiate chronic inflammatory diseases and, in certain cases, death. Moesers prior research linked psychological stress to a specific mast cell receptor and overreactive immune responses.

Moeser also previously discovered sex differences in mast cells. Female mast cells store and release more inflammatory substances like proteases, histamine and serotonin, compared with males. Thus, female mast cells are more likely than male mast cells to kick-start aggressive immune responses. While this may offer females the upper hand in surviving infections, it also can put females at higher risk for inflammatory and autoimmune diseases.

IBS is an example of this, says Mackey, whose doctoral research is part of this new publication.

While approximately 25% of the U.S. population is affected by IBS, women are up to four times more likely to develop this disease than men.

Moeser, Mackey and Jordans latest research explains why these sex-biased disease patterns are observed in both adults and prepubertal children. They found that lower levels of serum histamine and less-severe anaphylactic responses occur in males because of their naturally higher levels of perinatal androgens, which are specific sex hormones present shortly before and after birth.

Mast cells are created from stem cells in our bone marrow, Moeser said. High levels of perinatal androgens program the mast cell stem cells to house and release lower levels of inflammatory substances, resulting in a significantly reduced severity of anaphylactic responses in male newborns and adults.

We then confirmed that the androgens played a role by studying males who lack functional androgen receptors, says Jordan, professor of Neuroscience and an expert in the biology of sex differences.

While high perinatal androgen levels are specific to males, the researchers found that while in utero, females exposed to male levels of perinatal androgens develop mast cells that behave more like those of males.

For these females, exposure to the perinatal androgens reduced their histamine levels and they also exhibited less-severe anaphylactic responses as adults, says Mackey, who is currently a veterinary medical student at North Carolina State University.

In addition to paving the way for improved and potentially novel therapies for sex-biased immunological and other diseases, future research based will help researchers understand how physiological and environmental factors that occur early in life can shape lifetime disease risk, particularly mast cell-mediated disease patterns.

While biological sex and adult sex hormones are known to have a major influence on immunological diseases between the sexes, were learning that the hormones that we are exposed to in utero may play a larger role in determining sex differences in mast cell-associated disease risk, both as adults and as children, Moeser said.

For more information on Moesers research, go to the Gastrointestinal Stress Biology Laboratory. Also, visit the MSU College of Veterinary Medicines website for more about its research efforts.

(Note for media: Please include the following link to the study in all online media coverage: https://www.pnas.org/content/early/2020/09/10/1915075117)

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Oakland 24-year-old seeking multiethnic bone marrow donor – The Jewish News of Northern California

By daniellenierenberg

Its already hard enough for blood cancer patients to find a match through the international bone marrow registry, which pairs patients with potential donors who have the right type of tissue. But if youre Black and Jewish?

For people with multiple ethnic backgrounds who need marrow or stem cell transplants, matching is even harder.

I remember the doctor saying something like if he was an Irish white boy from Ireland, he might have a better chance, Monika Clark said about her son, 24-year-old Jordan Jackson-Clark of Oakland.

Jackson-Clark, whom his mom describes as mixed ethnicity and biracial, is likely to need a bone marrow transplant after a diagnosis of leukemia two weeks ago.

It was so out of the blue, Clark said. It was so unexpected.

Jackson-Clark had experienced a few bouts of intense stomach pain over the past summer, one strong enough to send him to the ER. Clark was concerned, but she was never expecting the recent call that they got from the doctor.

Through tears, Clark described the blow of hearing the diagnosis for her son, a Berkeley High School grad who was a camp counselor at the East Bay JCC and a member of the Jewish fraternity AEPi.

Hes just a gentle, loving young man, she said.

Jackson-Clark has acute myeloid leukemia, a cancer of the blood and bone marrow. Hes in the hospital getting chemotherapy for the next few weeks. In the meantime, knowing how difficult it will be to find a match for her son, Clark is desperately trying to get the word out about the bone marrow registry.

Please step out and do something very simple to save a life, she said.

The ethnic background of a cancer patient who needs a transplant matters, because the markers used to match a donor and patient are inherited. Having the same markers as a donor makes it a lot more likely that the patients body will accept the life-saving bone marrow or stem cells.

But the makeup of the database of potential donors is mostly white. For people of color and mixed race, the percentage of matches is 23 percent, and for white Caucasians its 77 percent, Clark said.

According to the nonprofit Gift of Life, while more than 12 percent of the American population is Black, only 4 percent on the registry are, and the percentages are similarly out of proportion for other ethnic groups.

Gift of Life was founded by Jay Feinberg, who was diagnosed with leukemia more than 20 years ago and needed a bone marrow transplant from a white Ashkenazi Jew. He sought a donor match, but at that time the database was sorely lacking in diversity. Efforts since then by his organization and others have greatly increased ethnic representation in the registry, but matches for mixed-ethnicity patients remain scarce. Jackson-Clark has the best chance of being matched with another person who is Black, white and Ashkenazi, but there simply arent many in the database.

The solution is getting more potential donors into the system. Clark is asking people to get tested with a simple cheek swab through Be the Match or any other registration service not only if they think they might be a match for her son, but also for all of the other patients out there who need matches. Optimal donor ages are 18 to 44; registration is free and can be done through the mail. That puts them on the international registry of potential donors, and the more people who are on the list, the more likely it is that they could be a match for a cancer patient.

Thats why Rabbi Yigal Rosenberg of Chabad of Santa Clara held a registration drive in February and encouraged young people to get on the list. When he got a call from Gift of Life a few days later, he thought it had something to do with the event.

They said, actually, you are a match! he said.

Rosenberg had the right kind of stem cells to help a 40-year-old man based on a swab hed given 10 years previously in New Jersey. (Whether marrow or stem cells are donated depends on the patients treatment needs.)

Im like, what are the chances? Rosenberg said. Literally I just hosted an event two days ago!

He immediately said yes and began a required series of injections to boost stem-cell production checking with another rabbi to make sure it was OK to have the shots on Shabbat as well.

This is the one thing youre allowed to compromise on, in Shabbat observance, is to save a life, he said.

Then, at the beginning of September, he drove down to San Bernardino, where he was put up in a hotel. He spent one day at the donation center attached to a machine that pumped blood out, filtered out and collected the stem cells, and returned the blood to his body. Rosenberg said the experience wasnt difficult at all.

I just felt so empowered during the entire process, he said.

He even livestreamed it on Facebook as a way to encourage more registrations, and to dispel some of the fear around donation. (Whether a patient requires the donors marrow or stem cells depends on the particular treatment protocol.)

I went right back to the hotel, jumped in the Jacuzzi for a bit and took a nap, he said. The next day he was back on his way to Santa Clara to resume his duties.

Clark, a former JCC preschool teacher, said it is important for people to know that donating stem cells and even bone marrow is not as intrusive or painful as it used to be. And anyone on the registry can always decide later that theyre not ready to donate, so getting the swab does not commit them to doing so.

The greatest Rosh Hashanah gift from the Jewish and biracial communities would be to spread the word far and wide with your communities, and to please get on the donor list by sending away for a simple and free cheek swab, she said. You just might save my or someone elses childs life.

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Pontypool family gives three lifesaving bone marrow donations – In Your Area

By daniellenierenberg

By InYourArea Community

The three generations of the Taylor family, Allan, Corey and Chris.

Three generations of a lifesaving family have defied the odds by being selected to donate their bone marrow to three complete strangers thousands of miles away.

Allan, Chris and Corey Taylor were all selected from the Welsh Bone Marrow Donor Registry as the only suitable matches in the world capable of saving patients from Africa, America and Europe respectively.

To mark World Bone Marrow Donor Day on Saturday, September 19, the Taylor family from Pontypool, Torfaen, is calling on 17-30 year olds across Wales to volunteer their lifesaving bone marrow by joining the Welsh Bone Marrow Donor Registry.

Chris Harvey, Head of the Welsh Bone Marrow Donor Registry, said:

Every day blood cancer patients around the world are desperately hoping to find a suitable bone marrow match. The requirements needed to match a patient with a bone marrow donor are very specific and this sadly means three in ten patients will never find the potentially lifesaving bone marrow donor they need.

Last year 50,000 donations were made from around 40 million volunteers signed up internationally, which shows just how rare it is to be someones match.

The Taylors really are a family of lifesavers.

Bone marrow is the soft, spongy tissue found at the centre of certain bones in your body where blood stem cells live. Blood stem cells produce all your essential blood cells, such as red blood cells to carry oxygen and white blood cells to fight infection. There are some diseases, such as some forms of leukaemia, which stop bone marrow working properly. For these patients, the best hope of recovery is to receive a bone marrow transplant.

Talking of his experience, 65 year old Allan, the eldest of the Taylor family donors said: A lot has changed since I donated back in 2005 but the constant has been the fantastic Welsh Bone Marrow Donor Registry staff who are always at hand throughout the process to look after you and to offer you reassurance and support.

Chris, 33, and the middle generation of the three donors, who currently works for Torfaen Council, recounted his experience: I was already a blood donor and decided one day to sign up to the Welsh Bone Marrow Donor Registry. I am a big Superman fan so Ive always dreamed of being a superhero. I cant fly but I was able to save a life by giving my bone marrow its as close as Ill ever get to being a hero!

My employer was absolutely fantastic and couldnt have been more supportive. The procedure, which lasted about four hours, was absolutely fine. After my donation I stayed for about 30 minutes, had a cup of tea and then I went home. I rested over the weekend and was straight back to work on the Monday.

The youngest donor in the family, 25 year old Corey, added: Theres a massive misconception and stigma out there around the bone marrow process. People seem to think they have to go through an operation type medical procedure which involves taking the bone marrow directly from your hip bone.

The reality is quite different as 85% of donations are collected through a non-surgical procedure very similar to a blood donation, it just takes a little longer and theres very little discomfort.

The PBSC process collects stem cells directly using a specialist machine. The process involves drawing blood out of one arm, extracting the stem cells, before returning the remaining blood to your other arm. Donors typically return to normal activity a day or two following the donation.

Allan Taylor summed up their achievement by saying:

I know people can talk about giving money but I think we have done something much more than that, we have potentially given three people the gift of life. You cant put a price on that! Ive done what I can. You can too.

If you are aged 17-30, do something amazing, join the Welsh Bone Marrow Donor Registry. Simply, book to give blood or call the Welsh Blood Service on 0800 252 266.

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Stem Cell Therapy Market to Witness Exponential Growth by 2020-2027 | Leading Players Osiris Therapeutics, Medipost Co., Anterogen Co., Pharmicell…

By daniellenierenberg

Fort Collins, Colorado The report on the Stem Cell Therapy Market provides an in-depth assessment of the Stem Cell Therapy market including technological advancements, market drivers, challenges, current and emerging trends, opportunities, threats, risks, strategic developments, product advancements, and other key features. The report covers market size estimation, share, growth rate, global position, and regional analysis of the market. The report also covers forecast estimations for investments in the Stem Cell Therapy industry from 2020 to 2027.

The report is furnished with the latest market dynamics and economic scenario in regards to the COVID-19 pandemic. The pandemic has brought about drastic changes in the economy of the world and has affected several key segments and growth opportunities. The report provides an in-depth impact analysis of the pandemic on the market to better understand the latest changes in the market and gain a futuristic outlook on a post-COVID-19 scenario.

Global Stem Cell TherapyMarketwas valued at 117.66 million in 2019 and is projected to reach USD255.37 million by 2027, growing at a CAGR of 10.97% from 2020 to 2027.

Get a sample of the report @ https://reportsglobe.com/download-sample/?rid=33553

The report provides an in-depth analysis of the key developments and innovations of the market, such as research and development advancements, product launches, mergers & acquisitions, joint ventures, partnerships, government deals, and collaborations. The report provides a comprehensive overview of the regional growth of each market player.

Additionally, the report provides details about the revenue estimation, financial standings, capacity, import/export, supply and demand ratio, production and consumption trends, CAGR, market share, market growth dynamics, and market segmentation analysis.

The report covers extensive analysis of the key market players in the market, along with their business overview, expansion plans, and strategies. The key players studied in the report include:

Furthermore, the report utilizes advanced analytical tools such as SWOT analysis and Porters Five Forces Analysis to analyze key industry players and their market scope. The report also provides feasibility analysis and investment return analysis. It also provides strategic recommendations to formulate investment strategies and provides insights for new entrants.

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The report is designed with an aim to assist the reader in taking beneficial data and making fruitful decisions to accelerate their businesses. The report provides an examination of the economic scenario, along with benefits, limitations, supply, production, demands, and development rate of the market.

1.Stem Cell Therapy Market, By Cell Source:

Adipose Tissue-Derived Mesenchymal Stem Cells Bone Marrow-Derived Mesenchymal Stem Cells Cord Blood/Embryonic Stem Cells Other Cell Sources

2.Stem Cell Therapy Market, By Therapeutic Application:

Musculoskeletal Disorders Wounds and Injuries Cardiovascular Diseases Surgeries Gastrointestinal Diseases Other Applications

3.Stem Cell Therapy Market, By Type:

Allogeneic Stem Cell Therapy Market, By Application Musculoskeletal Disorders Wounds and Injuries Surgeries Acute Graft-Versus-Host Disease (AGVHD) Other Applications Autologous Stem Cell Therapy Market, By Application Cardiovascular Diseases Wounds and Injuries Gastrointestinal Diseases Other Applications

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Regional Analysis of the Market:

For a better understanding of the global Stem Cell Therapy market dynamics, a regional analysis of the market across key geographical areas is offered in the report. The market is spread acrossNorth America, Europe, Latin America, Asia-Pacific, and Middle East & Africa.Each region is analyzed on the basis of the market scenario in the major countries of the regions to provide a deeper understanding of the market.

Benefits of the Global Stem Cell Therapy Report:

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Stem Cell Therapy Market to Witness Exponential Growth by 2020-2027 | Leading Players Osiris Therapeutics, Medipost Co., Anterogen Co., Pharmicell...

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Odessa woman hopes to gain back her sight after 6 years of being blind – NewsWest9.com

By daniellenierenberg

"It was like a curtain dropping over your eyes when youre going into the dark," Debbie Ramirez, Odessa resident said.

ODESSA, Texas Debbie Ramirez wakes up every morning just like you and I do.

She brushes her hair, like you and I do. She puts on mascara.

And then she puts on her shoes, just like you and I do.

Except, she doesn't get ready the way you and I do. That's because Debbie Ramirez is blind.

"I can see me moving my hand right in front of me, but right here I don't see anything," Debbie Ramirez, Odessa resident said.

It was six years ago when Debbie's life changed.

"It was like a curtain dropping over your eyes when you're going into the dark," Ramirez said.

That darkness not only took her sight. Debbie lost 75% of her memory and with it most of her life.

For years she sought out help from doctors. But none had an answer.

"They all told me they didn't know why I went blind. Nobody could explain it," Ramirez said.

"I thought how am I going to live like this? I've seen my entire life, I don't know how to live blind," Ramirez said.

Then one day, a phone call changed her life once again.

"I had a very large tumor. It was the size of an orange," Ramirez said.

An Odessa doctor finally had an answer. But what would come next was worse than you could imagine.

"He rushed me to Dallas by ambulance because he said I had less than 30 days to live," Ramirez said.

Her thoughts went straight to her family.

"My children are everything," Ramirez said.

And what would happen if she didn't make it through the surgery?

But the surgery was a success. The tumor was gone.

"I was me again and I just wanted to move on with life and grasp it because I had been given a second chance," Ramirez said.

Her memory started to come back, the pain and the headaches faded away, and Debbie began to take charge of her life again.

She re-learned how to cook, clean and even how to do laundry.

And now Debbie has a chance to get her sight back through a clinical trial in Florida.

"I am just really hoping to get my sight back more than anything. It's been the hardest thing I've ever gone through," Ramirez said.

The trial would use neurons from bone marrow to generate new stem cells in her retina and optic nerves. But there's one more roadblock before Debbie can see her children and grandson.

"It's a lot of money and my insurance will not cover it because it has to do with stem cell therapy," Ramirez said.

But Debbie said she's not giving up.

Although Debbie can't see, she says one thing is clear to her.

"I feel like God has always been beside me," Ramirez said.

________________________________________________________________

If you'd like to help Debbie with her mission to get her sight back, you can reach out to her directly at 432-212-5726.

She said she will take any help she can get!

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Odessa woman hopes to gain back her sight after 6 years of being blind - NewsWest9.com

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Researchers develop nanoclay-based bioprinting method to produce functional bone implants – 3D Printing Industry

By daniellenierenberg

Using 3D printers, researchers have collaborated from around the globe to develop nanoclay-based 3D bioprinted scaffolds which could be used to aid skeletal regeneration.

Hailing from the University of Southampton, the Istituto Italiano di Tecnologia in Rome, University Hospital Carl Gustav Carus and Technische Universitt in Dresden, and China Medical University in Taiwan, the researchers 3D bioprinted implantable nanocomposite scaffolds, laden with human bone marrow stromal cells (HBMSCs) and human umbilical vein endothelial cells (HUVECs), which have the potential to facilitate bone formation.

3D bioprinting for orthopedics

Ideally, 3D printed implants of this nature should sustain cell viability and promote cells to multiply, in addition to generating functional constructs shortly after printing and stimulating the host microenvironment to aid tissue growth.

Realistically, bioprinting is in its infancy and the prospect of whole 3D printed transplant organs is still probably decades away. However, there have been a number of innovative developments in the field thus far, such asa novel bio-ink enabling scientists at the University of Minnesota to create a functional 3D printed beating human heart.

Similarly, researchers fromTsinghua Universityhave3D bioprinted brain-like tissue structures capable of nurturing neural cells, while in May microdispensing specialistnScryptand aerospace companyTechShotsuccessfully completed the first functional 3D bioprinting experiment in space a human knee meniscus.

Most recently, researchers from theUniversity of Montrealhave developed a new method of cell bioprinting based on a drop-on-demand technique, called Laser Induced Side Transfer, which utilizes a low energy nanosecond laser and the laws of microfluidic dynamics to jet living cells onto each other. The team believes their work could be adapted for applications such as 3D drug screening models and artificial tissues.

The nanoclay-based method

According to the report,nanoclay-based bioink formulations are particularly attractive for implant applications given their ability, even at low concentrations, to shear while being extruded and regain their shape upon deposition, while shielding cells from potential damage from the printing process.

During the study, scientists harnessed the physiochemical properties of Laponite (LAP), a smectite nanoclay suspension, and combined it with HBMSCs, bone morphogenic protein-2 (BMP-2), and vascular endothelial growth factor to produce LAP-alginate-methylcellulose bioink. HBMSCs, collected from patients undergoing routine hip surgery, and HUVECs, obtained from the umbilical cords of healthy mothers after normal, full-term deliveries, were encapsulated in the bioink and printed using an in-house built bioprinter.

After printing, the scaffolds were incubated for 10 minutes in a sterile calcium chloride solution to enable crosslinking.

The skeletal functionality of the HBMSCs-laden 3D bioprinted scaffolds was investigated in vitro, ex vivo, and in vivo. The results demonstrated significant improvements in mineralized tissue formation with the addition of HBMSCs in 3DP, but not in mold-cast bulk scaffolds.

Significance of the findings

According to the researchers, the printing of bioinks laden with cells that can act as building blocks for the generation of tissue-like structures represents a simple and effective approach to produce readily implantable constructs.

The potential to print stem cells, preserving cell viability, proliferation, and functionality, is currently a key unmet challenge for the biofabrication approach to regenerative medicine. Clay-based bioinks, such as the one looked at in this study, are now proven to offer an attractive vehicle for printing HBMSCs in three-dimensional constructs due to their shear-thinning and inherent functional properties.

Further details of the study can be found in the article titledNanoclay-based 3D printed scaffolds promote vascular ingrowth ex vivo and generate bone mineral tissue in vitro and in vivo, published in the Biofabrication journal. The article is co-authored by Gianluca Cidonio, Michael Glinka, Yang-Hee Kim, Janos Kanczler, Stuart Lanham, Tilman Ahlfeld, Anja Lode, Jonathan Dawson, Michael Gelinsky, and Richard Oreffo.

The 4th annual 3D Printing Industry Awards are coming up in November 2020 and we need a trophy. To be in with a chance of winning a brand newCraftbot Flow IDEX XL3D printer,enter the MyMiniFactory trophy design competition here. Were happy to accept submissions until the 30th of September 2020.

Subscribe to the3D Printing Industry newsletterfor the latest news in additive manufacturing. You can also stay connected by following us onTwitterand liking us onFacebook.

Looking for a career in additive manufacturing? Visit3D Printing Jobsfor a selection of roles in the industry.

Featured image shows functional investigation of 3D printed scaffold vascularisation in a CAM model. Image via Biofabrication journal.

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The Pandemic Is Chasing Aging Coaches From the Field – The New York Times

By daniellenierenberg

After Coach Paul Trosclair won a Louisiana high school football championship in December 2018, he and his family walked from the Superdome in New Orleans to celebrate with a bowl of late-night gumbo. He mused about retiring, but no one took him seriously.

For five seasons, Trosclair had endured fatigue and other effects of multiple myeloma, a treatable but incurable blood cancer, missing only a single game. He coached from a golf cart when the burning sensation in his feet made it too painful to stand. And when he was sidelined that one Friday night after a blood clot required surgery, he phoned his players from his hospital bed to wish them luck.

With a state title at Eunice High School, after runner-up finishes there in 1997 and 1998, Trosclair had reached the pinnacle of a long, successful career. He was one of Louisianas winningest coaches. Back home on the Cajun prairie, he rode in a convertible during the towns victory parade, holding the championship trophy. He had nothing left to prove, but he stayed on for the 2019 season, elevating his career record to 247 victories even as medication left him with muscle cramps so severe at times that his fork fell from his fingers.

I couldnt pull the trigger, Trosclair, 64, said in a telephone interview. Its hard to walk away.

Now, he feels compelled, becoming one of a number of older coaches across the country who are choosing to retire rather than risk their health in the coronavirus pandemic.

In June, he gave his retirement notice after 40 years of coaching, the last 25 years at Eunice High. His cancer was in remission but his immune system was compromised. He did not think he could remain safe when a new school year and a new football season began. Not in a locker room where his players dress shoulder to shoulder. Not in the weight room. Not in crowded school hallways.

My doctors thought it was in my best interest not to coach, Trosclair said. I was on the edge; the coronavirus got me to jump over.

While young athletes are considered less vulnerable to Covid-19, the disease caused by the coronavirus, aging coaches are at higher risk of infection and having a severe response. At least 30 high school and club team coaches have died of coronavirus-related causes, according to a search of online obituaries. Though some were in their 70s, one was 27, another 30.

Countless other coaches have been forced to reconsider whether it is worth risking their health to continue their careers.

It remains unclear how many coaches have retired for reasons related to Covid-19. The N.C.A.A., the National Federation of State High School Associations, state athletic associations and coaching organizations said they have not kept such figures.

But a number of states have reported an uptick in teacher retirements, even if it is uncertain how many are related to the coronavirus. Louisiana, for instance, reported 335 retirements in August compared with 196 that month in 2019. In Ohio, the retirement rate more than doubled from July 1 through mid-August, compared to that period a year ago.

More so than in previous years, we are hearing about coaching staff retirees, said Jennifer Mann, a data technician with the Clell Wade Coaches Directory, a well-regarded national networking tool for coaches that tracks collegiate, high school and junior high school sports.

Even so, they may represent a fraction of coaches, though their departures often are deeply felt in their communities.

There are hundreds of thousands of high school coaches across the country in various sports, so even if there are hundreds who have retired, it is a pretty small number, Bruce Howard, a spokesman for the national high school federation, said in an email.

Some coaches who walked away said the pandemic had led them into deep introspection about their safety and their lifes direction.

Norm Ogilvie, 60, Duke Universitys longtime track and field coach, said in a statement that he felt there needs to be a final meaningful chapter for the remaining years I have on our rapidly changing planet.

Mike Fox, 64, retired after 22 years and seven trips to the College World Series as the baseball coach at the University of North Carolina. The coronavirus, he told the school, made him realize it is time for me to be a full-time husband, father and grandfather and do other things with my life.

Updated Sept. 18, 2020

Heres whats happening as the world of sports slowly comes back to life:

Joe Bustos, 57, who won two Arizona state basketball championships in 23 seasons coaching at North High School in Phoenix, stepped down, expressing frustration with virtual teaching and concern after two Arizona teachers died over the summer of Covid-19, including a 61-year-old high school swimming coach.

Im just afraid; I dont want to be playing Russian roulette, Bustos said in an interview. I love coaching and teaching, but at the end of the day youve got to look out for yourself.

Peter Kingsley, 54, taught middle school for nearly three decades in Boulder, Colo., and coached football, basketball, wrestling and track. But he has epilepsy and a circulatory condition that leaves him predisposed to strokes. His wife urged him to retire because of the pandemic. And he was influenced by spending 22 days in hospice with his father, who died this summer of bone cancer.

I had a choice to make whether to potentially die or keep coaching and teaching, Kingsley said in a telephone interview. I just needed to stay safe.

Trosclairs decision to leave coaching in Louisiana came reluctantly, after battling a cancer that he had never heard of until he learned he had it.

In spring 2014, he began to experience dizzy spells and fatigue. His blood pressure rose and his kidneys began to fail. The diagnosis was multiple myeloma, which begins in the bone marrow and limits the bodys ability to fight off infections, weakens bones, reduces kidney function and lowers a persons red blood cell count.

Trosclair began chemotherapy and taking a corticosteroid called Decadron, which left him intensely focused, insatiably hungry and agitated from extreme insomnia followed by bouts of crashing. He recalls his oncologist at the M.D. Anderson Cancer Center in Houston saying that he might lose his job in such a severe state. He jokingly replied, They already think Im crazy, so theyll give me a pass.

He asked one of his assistant coaches to remain vigilant in case his temper flared. Some days he felt 20 years old, he told a Louisiana reporter. Other days he felt 100. Still, Trosclair coached every game in the 2014 football season. In early 2015, he underwent a stem cell transplant. His own blood-making stem cells were harvested, frozen, then reintroduced after chemotherapy to produce new, healthy blood cells. He spent six weeks in Houston for the treatment and recovery.

People in Eunice raised some money and it was a big help, Trosclair said.

Months later, though, a mix-up over blood thinners during the 2015 football season led to a blood clot in his left leg and forced him into intensive care at a hospital in Lafayette, La. His left foot swelled to three times its normal size. Three surgeries were required, causing him to miss his only game in 25 seasons. Trosclair spoke to his team beforehand by phone, saying, I love you. Go out and play.

Irma Trosclair, his wife and the superintendent of schools in Lafayette Parish, one of Louisianas largest school districts, still keeps a video of the bedside pep talk.

When I saw him doing that, with all those tubes he had going, I knew that coaching wasnt just work, she said. It was what was going to pull him through.

In 2018, Eunice High unexpectedly reached the Class 3A state championship game and prevailed, 59-47, with Trosclairs Wing-T offense, an intricate symphony of misdirection and strategic passing. After a quarter century at the school and five seasons of fighting cancer, he claimed his biggest football victory. Trosclair told a television interviewer, It was like the universe opened its doors and said, here you go, heres a gift for you.

The high school and its football team confirm that Eunice still measures up, even as its population and student enrollment continue to shrink and a third of its 9,800 residents live in poverty. It is the only traditional public high school in St. Landry Parish to carry an A-rating of academic performance from the state and has maintained its diversity a half century after desegregation.

When you think of Eunice High, you think of Coach Trosclair, said the principal, Mitch Fontenot. Everybody looks up to him. He has a real calming effect. Its a big loss.

Sixteen starters were to return for the 2020 season. Another deep playoff run seemed possible. But the coronavirus shuttered Louisiana schools in March and the state became a hot spot. Trosclair no longer felt he could protect himself and manage his team safely at the same time. Retirement began to seem inevitable.

On June 18, Trosclair saw Dr. Donna M. Weber, his oncologist at M.D. Anderson, who wrote in a letter that he was at particular risk of infection during the pandemic and that she advised him not to return to work.

Irma Trosclair said, He needed his doctor to tell him he absolutely had no other option. I think hes very much at peace with it.

There has been sobering validation of Trosclairs decision. The athletic director of an area high school also retired with multiple myeloma. The father of one of Trosclairs former players died of Covid-19. Trosclairs replacement at Eunice High, interim coach Andre Vige, 41, tested positive, along with two Eunice High players, one of whom was hospitalized. All have recovered. Two teenage brothers in the area, the youngest a football player, also contracted the virus. The elder brother died at age 19.

Its possible for young people to die, Trosclair said. Thats the scary thing.

He spent the summer playing golf, taking 6 a.m. walks around the Eunice High track and lifting weights at the school when no one was around. He takes Revlimid, a maintenance medication, three weeks of every four. And while fatigue and muscle spasms persist, acupuncture has helped relieve the burning feeling in his feet. His red blood cell count and other markers are encouraging. Still, he has avoided large gatherings.

When the Eunice city council honored him, his wife went in his place. His grandchildren have not visited since March. When his youngest son, Trenon, 26, got married in June, Trosclair sat in an isolated section of the church, then left through a side door and skipped the reception.

Im really sad right now, he texted his wife.

Louisianas delayed high school football season is set to begin on Oct. 1. Trosclair would like to remain involved with the team in some manner. He has studied plays at the dining room table with Trenon, the teams secondary coach. Perhaps he will help with game planning. He would like to attend games, if he can stand away from everyone, but his wife is skeptical. She has another idea.

Hopefully theyll let me keep my same parking spot, Irma Trosclair said. Then we can watch the whole game from my vehicle. Surely theyll grant that for Coach.

Gillian Brassil contributed reporting. Sheelagh McNeill and Susan Beachy contributed research.

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Silent spreaders of the coronavirus are the target of a new testing venture in San Antonio – San Antonio Express-News

By daniellenierenberg

After Graham Weston caught the coronavirus from his son, who hadnt shown any symptoms, the San Antonio tech entrepreneur realized that the role of silent spreaders demanded more attention.

He and other prominent philanthropic leaders in the city formed a new nonprofit with the express purpose of screening hundreds and eventually thousands of people to identify who is infected and asymptomatic and keep them from unknowingly spreading the virus.

The larger goal is even more ambitious: deliver an effective way of supporting societys recovery from the pandemic.

We can never really suppress the virus and give people the confidence to go back (to school or work) when we have silent spreaders walking through our population, said Weston, founder of the 80 | 20 Foundation and former CEO and chairman of Rackspace Technology.

The nonprofit, called Community Labs, has adopted a new approach to testing that focuses on micro populations in shared places, such as area schools and businesses.

It is using an existing test developed by Thermo Fisher Scientific. The polymerase chain reaction, or PCR, test relies on a sample taken from the front of the nostril easier on the person getting tested. Results will be available within 24 hours, far faster than many providers of coronavirus tests, the nonprofits leaders said Thursday during their announcement of the initiative.

The nonprofit will pilot the testing effort in the Somerset Independent School District. It has the capacity to process 600 tests a day and aims to scale up to 12,000 tests a day by November, with the goal of lowering the price to $35 per test.

Community Labs is working with BioBridge Global, which houses the nonprofit and conducts the testing in collaboration with UT Health San Antonio. BioBridge, which operates San Antonios blood bank, owns its own lab off Interstate 10 near Vance Jackson on the West Side.

Experts estimate that up to half of people who contract the coronavirus may display no symptoms, said bank executive J. Bruce Bugg Jr., chairman and trustee of the Tobin Endowment and co-founder of Community Labs. While hospitals have widely screened patients for the coronavirus when they are scheduled for surgery, federal and local health officials have largely prioritized testing people with symptoms.

On ExpressNews.com: New nonprofit aims to improve COVID-19 testing

Its an approach that has persisted since early in the pandemic, when testing for the coronavirus was severely limited by regulatory, processing and supply chain bottlenecks. Health departments, including the San Antonio Metropolitan Health District, initially focused their efforts on people who were severely ill, those with classic symptoms and front-line workers.

Metro Health briefly tested asymptomatic people in the community earlier this year but halted the effort when a surge of cases over the summer caused demand for testing to skyrocket.

While testing those with symptoms may help diagnose people with COVID-19, it does little to halt chains of transmission that stem from asymptomatic carriers. To fill that testing gap, Community Labs is taking the exact opposite approach, Bugg said.

He said the goal is to create a strong testing model that screens for asymptomatic carriers and that can be replicated and applied in cities across the state.

Community Labs approach hinges on quick turnaround times, which are not typical with the traditional testing. Waiting a week for results would render the value of testing asymptomatic people moot, Weston said, as they wont know to isolate themselves and already could have spread the virus to others by the time they learn they are infected.

Dr. Rachel Beddard, chief medical officer of BioBridge, said the company already conducts fast, high-volume testing for communicable diseases on blood products collected by the South Texas Blood and Tissue Center and on tissue, bone marrow and stem cells gathered by GenCure, another subsidiary.

Earlier this year, federal regulators granted an emergency use authorization for the coronavirus test that BioBridge is using.

On ExpressNews.com: San Antonio students are back in classrooms very different classrooms

Somerset ISD, a seven-school system in rural Southwest Bexar County, was selected as a demonstration site after its superintendent, Saul Hinojosa, agreed to participate.

With about 40 percent of all students having returned to school for in-person learning, the district will begin testing students and staff Wednesday, starting with students involved in extracurricular activities, all high school staff and all nurses and police officers. Only students whose parents sign a consent form will be tested at school, Hinojosa said.

The goal is to test as many students as possible so they, their parents and staff feel comfortable returning to school. If everything goes according to plan and enough students agree to get tested, Hinojosa said, the entire district could be back learning face to face earlier than expected.

We need students in the classroom because thats where they learn best, and we hope that this strategy will lessen the concern on parents, along with the anxiety, to where they feel confident that the school campus is a safe environment for the kids, he said.

Unlike the deep nasal swabs that have been used to collect samples for many coronavirus tests, the test used by Community Labs uses a sample thats simpler and far less invasive to collect. Participants rub a small Q-tip inside each nostril for five seconds before dropping it into a test tube.

Community Labs was co-founded by Weston, Bugg and J. Tullos Wells, managing director of the Kronkosky Charitable Foundation. Weston is serving as chairman, while Bugg and Wells are vice chairmen.

The Kronkosky and 80 | 20 foundations and the Tobin Endowment have contributed a combined $2.5 million to start the nonprofit.

Lauren Caruba covers health care and medicine in the San Antonio and Bexar County area. To read more from Lauren, become a subscriber. lcaruba@express-news.net | Twitter: @LaurenCaruba

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Block party planned to raise awareness of sickle cell disease – Greenville Journal

By daniellenierenberg

Life expectancy for people with sickle cell disease appears to be declining, and the same systemic racism being protested around the nation could be at least partly responsible, a local expert says.

If you compare other orphan diseases, like cystic fibrosis or hemophilia, which have less cases than sickle cell, and then compare funding and research, its a night-and-day difference, said Dr. Alan R. Anderson, director of Prisma Health Upstates Comprehensive Sickle Cell Disease Program.

The U.S. Food and Drug Administration defines an orphan disease as a condition that affects fewer than 200,000 people nationwide.

That directly goes along with this same prejudice, racial disparities that we see in our political-social landscape, he said. Its about time we recognize this is a serious problem.

Anderson points to a National Institutes of Health study that concluded that life expectancy dropped from 42 for men and 48 for women in the early 1990s to 42 for women and 38 for men in 2005 even as life expectancy increased for people with other chronic conditions.

And a Sept. 1 New England Journal of Medicine article reports that while cystic fibrosis affects a third fewer than sickle cell, it receives seven to 11 times the funding. The authors added that the development of disease-modifying therapies has stagnated because of inadequate research funding, attributable at least in part to structural racism.

Sickle cell disease (SCD) is a genetic disorder of the red blood cells that primarily affects African Americans, though people from Hispanic, southern European, Middle Eastern, southern Asia, or Asian Indian backgrounds can also get the disease. Both parents must carry the genes for their child to get the disease.

While healthy cells are round, in people with SCD they resemble a sickle, or C shape, and are also hard and sticky, clogging the flow of blood through the vessels, according to the U.S. Centers for Disease Control and Prevention. Symptoms include pain, infections and stroke, and typically begin when a child is around 5 months old.

Treatments include medicines that can reduce complications and extend life, the agency reports, but the only cure is a risky bone marrow or stem cell transplant from a close match, like a brother or sister.

The state Department of Health and Environmental Control says that despite improvements in treatments, SCD remains a life-limiting disease with multi-organ complications that reduces the quality of life of impacted individuals especially as the person ages.

DHEC also reports that SCD has suffered from decades of poor disease awareness and lack of funding compared to other inherited disorders.

Historically, Anderson said, while children are cared for via Medicaid, adults often lack insurance so they have no medical home. And along with the funding disparity, there is a lack of training for medical professionals about SCD.

This is not rocket science, he said. If you focus on sickle cell disease like you do on diabetes and other chronic diseases, we will see reductions in acute care needs that will ultimately manifest in life expectancy.

DHEC has an SCD plan that calls for improving access to care, sustainable funding and increasing the educational awareness of medical professionals about SCD.

Its going to take more research and more advocacy and, I believe, policy changes, said the Rev. Sean Dogan of Long Branch Baptist Church in Greenville. We need that same momentum for SCD as well.

Anderson said that Prismas program has stepped up preventive health strategies and treatments for people of all ages while reducing ER visits and hospitalizations by about 50%, which will hopefully increase life expectancy.

Last year, it launched Camp Crescent to provide SCD patients and their families a respite from the disease. But the pandemic prevented that this year.

So organizers are holding a block party from 4-6 p.m. on Sept. 19 where people can safely gather for some fun and to raise awareness, said Dogan.

Its going to be an exciting event to raise awareness [and] celebrate those who have SCD and their caregivers, he said. The more awareness the community has, the more support it will give. And our community is a very generous community.

Modeled on the drive-by birthday parties so popular during the pandemic, it will feature patients and their families driving by the entrance of Prismas Cancer Center on Faris Road, he said. There, theyll find encouragement, well wishes and fun activities like quizzes with prizes, he said.

Meanwhile, on Sunday, blood drives to benefit patients will be held in the area, including one at Long Branch from 10 a.m. to 2 p.m., he said.

To learn more about the event, go to http://events.r20.constantcontact.com/register/event?oeidk=a07eh9btc8wd9af19f2&llr=76g5y7tab or https://www.ghschildrens.org/programs/camp-crescent/.

While the exact number of people with SCD is unknown, its estimated they number about 100,000 nationwide.

South Carolina doesnt track SCD numbers, but between 1991 and 2017, 1,884 infants were born with it, DHEC said. Another 56,607 were born with sickle cell trait, which means they dont have symptoms but can pass the gene on to their children.

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Convergence: EMA close to finalizing guidance for advanced therapies – Regulatory Focus

By daniellenierenberg

The European Medicines Agency is on the verge of releasing revised guidance for advanced therapy medicinal products containing genetically modified cells, which includes chimeric antigen receptor (CAR)-T cell therapies.

The Guideline on quality, non-clinical and clinical aspects of medicinal products containing genetically modified cells was originally issued in 2012 but underwent revision and consultation from July 2018-July 2019. The revised version is expected to be adopted in October and published in November, according to Ana Hidalgo-Simon, MD, PhD, head of advanced therapies at EMA. She previewed the major changes at RAPS Convergence 2020.

There were an enormous number of comments on the document, Hidalgo-Simon said.The agency is also working on a Q&A document on principles of good manufacturing practices (GMP) for Advanced Therapy Medicinal Products (ATMP) starting material. There will likely be consultation on the document in 2021, she said. (RELATED: Regulation of advanced therapy medicinal products in the EU, Regulatory Focus, 16 July 2020.)

Major changesEMA chose to update the guidance to reflect the increase in clinical experience with these therapies, particularly chimeric antigen receptor-T (CAR-T) cells; to cover new categories of products, such as induced pluripotent stem (iPS) cells; and to allow for consideration of new tools for genetic modification of cells, such as genome editing technologies, she said.

The main quality updates are related to starting materials, the manufacturing process, and characterization and release. For example, the starting materials guidance will now include genome editing tools, while the manufacturing process includes a new section on comparability. The characterization and release portion of the guidance includes specific advice for CAR-T cells.

Additionally, the guidance calls for dose-finding studies to explore safety, toxicity, and anti-tumor activity at different dose levels, to define the threshold dose required for anti-tumor effect, and to define the recommended dose or range for Phase 2 studies. She said sponsors need to show a solid rationale for the criteria being used to find the dose.

The guidance also calls for Phase 3 confirmatory trials to follow a randomized controlled design, comparing the CAR-T cell therapy to a reference regimen, unless otherwise scientifically justified. Single-arm studies will continue to be allowed, but they will be the exception, Dr. Hidalgo-Simon said.

Be very careful with the design of the trials, she advised. The assumptions need to be really, very well backed.

When it comes to safety, the guidance calls for a 15-year follow period. While sponsors wont have all the answers at the time of submission, Hidalgo-Simon said they should have a plan that includes monitoring during the post-authorization period.

Hidalgo-Simon also advised sponsors to think beyond the approval process and consider what evidence will be needed to convince other stakeholders -- from patients to payers -- about the safety and efficacy of the therapy.

Avoiding development pitfallsRichard Dennett, PhD, the senior director of chemistry, manufacturing and controls regulatory affairs at PPD, also participated in the RAPS Convergence 2020 session on advanced therapies. He reviewed development points where companies can run into trouble with advanced therapies, particularly CAR-T cell products.Dennett recommended that product sponsors keep the end in mind when developing advanced therapies by focusing on the target product profile at the beginning of development. That profile includes the indication for which approval will be sought and the incidence of that indication; other considerations include mode of action, demographics, how much of the product needs to be produced, and market access and reimbursement considerations.

He also outlined several areas where developers should focus to create a watertight regulatory package, including sufficient product characterization, potency assay, impurities, formulation, stability, lack of sufficient development batches, and validation strategy.

Dennett urged developers to dive into the growing number of regulatory guidance documents for advanced therapies. In addition to the European guidance documents, developers should consultthe US Food and Drug Administrations Chemistry, Manufacturing, and Control (CMC) Information for Human Gene Therapy Investigational New Drug Applications (INDs), which was released in January 2020. (RELATED: Advanced therapies: Trip hazards on the development pathway, Regulatory Focus, 02 August 2020)

Live and breathe the guidances that are out there, Dennett advised. They allow us to understand what expectations we need to meet.

The key to success in advancing CAR-T cell therapies is the mitigation of risk, Dennett said: The biggest risk is the one that you havent thought of.RAPS 2020 Convergence

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Cord Stem Cell Banking Market Analysis 2020 With COVID 19 Impact Analysis| Leading Players, Business Prospects, In-depth Analysis Research Report…

By daniellenierenberg

Global stem cell banking market is set to witness a substantial CAGR of 11.03% in the forecast period of 2019- 2026. The report contains data of the base year 2018 and historic year 2017. The increased market growth can be identified by the increasing procedures of hematopoietic stem cell transplantation (HSCT), emerging technologies for stem cell processing, storage and preservation. Increasing birth rates, awareness of stem cell therapies and higher treatment done viva stem cell technology.

Get Sample Report + All Related Graphs & Charts (with COVID 19 Analysis) @https://www.databridgemarketresearch.com/request-a-sample/?dbmr=global-stem-cell-banking-market&pm

Competitive Analysis:

Global stem cell banking market is highly fragmented and the major players have used various strategies such as new product launches, expansions, agreements, joint ventures, partnerships, acquisitions, and others to increase their footprints in this market. The report includes market shares of inflammatory disease drug delivery market for Global, Europe, North America, Asia-Pacific, South America and Middle East & Africa.

Key Market Competitors:

Few of the major competitors currently working in global inflammatory disease drug delivery market are: NSPERITE N.V, Caladrius, ViaCord, CBR Systems, Inc, SMART CELLS PLUS, LifeCell International, Global Cord Blood Corporation, Cryo-Cell International, Inc., StemCyte India Therapeutics Pvt. Ltd, Cordvida, ViaCord, Cryoviva India, Vita34 AG, CryoHoldco, PromoCell GmbH, Celgene Corporation, BIOTIME, Inc., BrainStorm Cell Therapeutics and others

Market Definition:Global Stem Cell Banking Market

Stem cells are cells which have self-renewing abilities and segregation into numerous cell lineages. Stem cells are found in all human beings from an early stage to the end stage. The stem cell banking process includes the storage of stem cells from different sources and they are being used for research and clinical purposes. The goal of stem cell banking is that if any persons tissue is badly damaged the stem cell therapy is the cure for that. Skin transplants, brain cell transplantations are some of the treatments which are cured by stem cell technique.

Cord Stem Cell Banking MarketDevelopment and Acquisitions in 2019

In September 2019, a notable acquisition was witnessed between CBR and Natera. This merger will develop the new chances of growth in the cord stem blood banking by empowering the Nateras Evercord branch for storing and preserving cord blood. The advancement will focus upon research and development of the therapeutic outcomes, biogenetics experiment, and their commercialization among the global pharma and health sector.

Cord Stem Cell Banking MarketScope

Cord Stem Cell Banking Marketis segmented on the basis of countries into U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

All country based analysis of the cord stem cell banking marketis further analyzed based on maximum granularity into further segmentation. On the basis of storage type, the market is segmented into private banking, public banking. On the basis of product type, the market is bifurcated into cord blood, cord blood & cord tissue. On the basis of services type, the market is segmented into collection & transportation, processing, analysis, storage. On the basis of source, market is bifurcated into umbilical cord blood, bone marrow, peripheral blood stem, menstrual blood. On the basis of indication, the market is fragmented into cerebral palsy, thalassemia, leukemia, diabetes, autism.

Cord stem cell trading is nothing but the banking of the vinculum plasma cell enclosed in the placenta and umbilical muscle of an infant. This ligament plasma comprises the stem blocks which can be employed in the forthcoming time to tackle illnesses such as autoimmune diseases, leukemia, inherited metabolic disorders, and thalassemia and many others.

Market Drivers

Increasing rate of diseases such as cancers, skin diseases and othersPublic awareness associated to the therapeutic prospective of stem cellsGrowing number of hematopoietic stem cell transplantations (HSCTs)Increasing birth rate worldwide

Market Restraint

High operating cost for the therapy is one reason which hinders the marketIntense competition among the stem cell companiesSometimes the changes are made from government such as legal regulations

Key Pointers Covered in the Cord Stem CellBanking MarketIndustry Trends and Forecast to 2026

Market SizeMarket New Sales VolumesMarket Replacement Sales VolumesMarket Installed BaseMarket By BrandsMarket Procedure VolumesMarket Product Price AnalysisMarket Healthcare OutcomesMarket Cost of Care AnalysisMarket Regulatory Framework and ChangesMarket Prices and Reimbursement AnalysisMarket Shares in Different RegionsRecent Developments for Market CompetitorsMarket Upcoming ApplicationsMarket Innovators Study

Key Developments in the Market:

In August, 2019, Bayer bought BlueRock for USD 600 million to become the leader in stem cell therapies. Bayer is paying USD 600 million for getting full control of cell therapy developer BlueRock Therapeutics, promising new medical area to revive its drug development pipeline and evolving engineered cell therapies in the fields of immunology, cardiology and neurology, using a registered induced pluripotent stem cell (iPSC) platform.In August 2018, LifeCell acquired Fetomed Laboratories, a provider of clinical diagnostics services. The acquisition is for enhancement in mother & baby diagnostic services that strongly complements stem cell banking business. This acquisition was funded by the internal accruals which is aimed to be the Indias largest mother & baby preventive healthcare organization.

For More Insights Get FREE Detailed TOC @https://www.databridgemarketresearch.com/toc/?dbmr=global-stem-cell-banking-market&pm

Research objectives

To perceive the most influencing pivoting and hindering forces in Cord Stem Cell Banking Market and its footprint in the international market.Learn about the market policies that are being endorsed by ruling respective organizations.To gain a perceptive survey of the market and have an extensive interpretation of the Cord Stem Cell Banking Market and its materialistic landscape.To understand the structure of Cord Stem Cell Banking Market by identifying its various sub segments.Focuses on the key global Cord Stem Cell Banking Market players, to define, describe and analyze the sales volume, value, market share, market competition landscape, SWOT analysis and development plans in next few years.To analyze competitive developments such as expansions, agreements, new product launches, and acquisitions in the market.To share detailed information about the key factors influencing the growth of the market (growth potential, opportunities, drivers, industry-specific challenges and risks).To project the consumption of Cord Stem Cell Banking Market submarkets, with respect to key regions (along with their respective key countries).To strategically profile the key players and comprehensively analyze their growth strategiesTo analyze the Cord Stem Cell Banking Market with respect to individual growth trends, future prospects, and their contribution to the total market.

Customization of the Report:

All segmentation provided above in this report is represented at country levelAll products covered in the market, product volume and average selling prices will be included as customizable options which may incur no or minimal additional cost (depends on customization)

Contact:

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Email @[emailprotected]

About Data Bridge Market Research:

An absolute way to forecast what future holds is to comprehend the trend today!Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.

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Here’s what to know about Sickle Cell Disease in kids – Loma Linda University Health

By daniellenierenberg

With September being Sickle Cell Disease Awareness Month, Loma Linda University Childrens Health wants to help educate the community about SCD one of the most common yet overlooked genetic disorders in the world.

Each year, approximately 1,000 babies in the U.S. and 500,000 worldwide are born with the disease, according to the Sickle Cell Disease Association of America.

Akshat Jain, MD, MPH, a global sickle cell disease expert at Childrens Hospital, is passionate about establishing awareness and proper care for children suffering from SCD and Sickle Cell Trait, especially the diverse patient population in San Bernardino County.

There are many barriers to receiving care for those with SCD in our community, Jain says. One barrier specifically is lack of awareness surrounding the disease coupled with lack of awareness surrounding the treatment options available at Childrens Hospital.

In sickle cell disease, a persons red blood cells have an irregular cell shape, Jain says. Instead of round discs, theyre in a crescent or sickle shape.

Due to their shape, texture and inflexibility, the cells become clumped together. This grouping causes a blockage in a childs blood vessels, hindering blood-flow. This blockage may cause varying levels of pain and potentially organ damage long-term.

Jain says some of the signs and symptoms of SCD include:

Jain says that many children with SCD develop symptoms in their first year of life. SCD is commonly diagnosed during newborn screening tests, which check for the abnormal hemoglobin found in SCD. Additionally, if both parents of a child are known carriers of a SCD trait, their child will have a 25% chance of having the disease, Jain says.

Some of the emergent issues needing immediate medical care in kids with SCD disease include:

Treatments for SCD include pain medicines for pain management, adequate hydration, blood transfusions, vaccines and antibiotics, and some medicines. Currently, stem cell transplant from bone marrow is the recognized cure for SCD.

Childrens Hospital, with Jain working as a lead on the team, performed the institutions first stem cell transplant in 2019, curing a then 11-year-old girl who had suffered from SCD since birth. Since then, the team has successfully performed the transplant on several pediatric patients.

Patients with SCD at Childrens Hospital are placed into a treatment and care program where Jain and his team offer non-traditional services such as individualized patient treatment plans and direct access to the care team in case of an emergent event. Additionally, the program is working toward offering curative gene therapy for both sickle cell and hemophilia patients.

The bottom line is children and families suffering from this disease need to know that theyre not alone, Jain says. Here at Childrens Hospital, we are here to manage and fight this disease alongside of you.

Learn more about our treatments for sickle cell disease at our Specialty Team Centers.

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Species-specific pace of development is associated with differences in protein stability – Science Magazine

By daniellenierenberg

Setting the tempo for development

Many animals display similarities in their organization (body axis, organ systems, and so on). However, they can display vastly different life spans and thus must accommodate different developmental time scales. Two studies now compare human and mouse development (see the Perspective by Iwata and Vanderhaeghen). Matsuda et al. studied the mechanism by which the human segmentation clock displays an oscillation period of 5 to 6 hours, whereas the mouse period is 2 to 3 hours. They found that biochemical reactions, including protein degradation and delays in gene expression processes, were slower in human cells compared with their mouse counterparts. Rayon et al. looked at the developmental tempo of mouse and human embryonic stem cells as they differentiate to motor neurons in vitro. Neither the sensitivity of cells to signals nor the sequence of gene-regulatory elements could explain the differing pace of differentiation. Instead, a twofold increase in protein stability and cell cycle duration in human cells compared with mouse cells was correlated with the twofold slower rate of human differentiation. These studies show that global biochemical rates play a major role in setting the pace of development.

Science, this issue p. 1450, p. eaba7667; see also p. 1431

What determines the pace of embryonic development? Although the molecular and cellular mechanisms of many developmental processes are evolutionarily conserved, the pace at which these operate varies considerably between species. The tempo of embryonic development controls the rate of individual differentiation processes and determines the overall duration of development. Despite its importance, however, the mechanisms that control developmental tempo remain elusive.

Comparing highly conserved and well-characterized developmental processes in different species permits a search for mechanisms that explain differences in tempo. The specification of neuronal subtype identity in the vertebrate spinal cord is a prominent example, lasting less than a day in zebrafish, 3 to 4 days in mouse, and around 2 weeks in human. The development of the spinal cord involves a well-defined gene regulatory program comprising a series of stereotypic changes in gene expression, regulated by extrinsic signaling as cells differentiate from neural progenitors to postmitotic neurons. The regulatory program and resulting neuronal cell types are highly similar in different vertebrates, despite the difference in tempo between species. We therefore set out to characterize the pace of differentiation of one specific neuronal subtypemotor neuronsin human and mouse and to identify molecular differences that explain differences in pace. To this end, we took advantage of the in vitro recapitulation of in vivo developmental programs using the directed differentiation of human and mouse embryonic stem cells.

We found that all stages of the developmental progression from neural progenitor to motor neuron were proportionally prolonged in human compared with mouse, resulting in human motor neuron differentiation taking about 2.5 times longer than mouse. Differences in tempo were not due to differences in the sensitivity of cells to signals, nor could they be attributed to differences in the sequence of the key genes or their regulatory elements. Instead, the data revealed that changes in protein stability correlated with developmental tempo, such that slower temporal progression in human corresponded to increased protein stability. An in silico model indicated that increased protein stability could account for the slower tempo of development in human compared with mouse.

The results suggest that differences in protein turnover play a role in interspecies differences in the pace of motor neuron differentiation. The identification of a molecular mechanism that can explain differences in the pace of embryonic development between species focuses attention on the role of protein stability in tempo control. This suggests a parsimonious explanation for the substantial variation in the tempo of development between species and indicates how the overall dynamics of developmental processes can be influenced by kinetic properties of gene regulation. What determines species-specific rates of protein turnover remains to be determined, but the availability of in vitro systems that mimic in vivo developmental tempo opens up the possibility of exploring this issue.

Different animal species develop at different tempos, and equivalent developmental stages can be matched between mouse and human at different developmental time points. Neural progenitors in the spinal cord progress through the same succession of gene expression to generate motor neurons in mouse and human, and this serves as a model to study tempo differences. The in vitro directed differentiation of mouse embryonic stem cells to motor neurons advances at greater than twice the speed of human embryonic stem cell differentiation. The equivalent progression of development at different rates is shown for the transcription factors PAX6 (green), OLIG2 (red), and NKX2.2 (blue). E, embryonic day; W, embryonic week; CS, Carnegie stage. Scale bars are 50 m.

Although many molecular mechanisms controlling developmental processes are evolutionarily conserved, the speed at which the embryo develops can vary substantially between species. For example, the same genetic program, comprising sequential changes in transcriptional states, governs the differentiation of motor neurons in mouse and human, but the tempo at which it operates differs between species. Using in vitro directed differentiation of embryonic stem cells to motor neurons, we show that the program runs more than twice as fast in mouse as in human. This is not due to differences in signaling, nor the genomic sequence of genes or their regulatory elements. Instead, there is an approximately two-fold increase in protein stability and cell cycle duration in human cells compared with mouse cells. This can account for the slower pace of human development and suggests that differences in protein turnover play a role in interspecies differences in developmental tempo.

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Researchers Discover a Way To Create Induced Tropoblast Stem Cells – Technology Networks

By daniellenierenberg

An international collaboration involving Monash University and Duke-NUS researchers have made an unexpected world-first stem cell discovery that may lead to new treatments for placenta complications during pregnancy.

While it is widely known that adult skin cells can be reprogrammed into cells similar to human embryonic stem cells that can then be used to develop tissue from human organs - known as induced pluripotent stem cells (iPSCs) - the same process could not create placenta tissue.

iPSCs opened up the potential for personalised cell therapies and new opportunities for regenerative medicine, safe drug testing and toxicity assessments, however little was known about exactly how they were made.

An international team led by ARC Future Fellow Professor Jose Polo from Monash University's Biomedicine Discovery Institute and the Australian Research Medicine Institute, together with Assistant Professor Owen Rackham from Duke-NUS in Singapore, examined the molecular changes the adult skin cells went through to become iPSCs. It was during the study of this process that they discovered a new way to create induced trophoblast stem cells (iTSCs) that can be used to make placenta cells.

This exciting discovery, also involving the expertise of three first authors, Dr. Xiaodong Liu, Dr. John Ouyang and Dr. Fernando Rossello, will enable further research into new treatments for placenta complications and the measurement of drug toxicity to placenta cells, which has implications during pregnancy.

"This is really important because iPSCs cannot give rise to placenta, thus all the advances in disease modelling and cell therapy that iPSCs have brought about did not translate to the placenta," Professor Polo said.

"When I started my PhD five years ago our goal was to understand the nuts and bolts of how iPSCs are made, however along the way we also discovered how to make iTSCs," said Dr Liu.

"This discovery will provide the capacity to model human placenta in vitro and enable a pathway to future cell therapies," commented Dr Ouyang.

"This study demonstrates how by successfully combining both cutting edge experimental and computational tools, basic science leads to unexpected discoveries that can be transformative," Professor Rackham said.

Professors Polo and Rackham said many other groups from Australian and international universities contributed to the study over the years, making it a truly international endeavour.

Reference:Liu, X., Ouyang, J.F., Rossello, F.J. et al. Reprogramming roadmap reveals route to human induced trophoblast stem cells. Nature (2020). https://doi.org/10.1038/s41586-020-2734-6

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Researchers Discover a Way To Create Induced Tropoblast Stem Cells - Technology Networks

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Curi Bio Announces Mantarray Platform for Analysis of 3D Engineered Muscle Tissues for Discovery of New Therapeutics – BioSpace

By daniellenierenberg

Sept. 15, 2020 16:00 UTC

Curis Platforms are Accelerating Drug Discovery with Human-Relevant 3D Engineered Muscle Tissue Analysis

SEATTLE--(BUSINESS WIRE)-- Curi Bio, a leading developer of human stem cell-based platforms for drug discovery, today announced the Mantarray platform for human-relevant 3D engineered muscle tissue (EMT) analysis. Curis Mantarray platform enables the discovery, safety, and efficacy testing of new therapeutics by providing parallel analysis of 3D EMTs with adult human-like functional profiles. By providing drug developers human-relevant tissue-specific biosystems in the preclinical stage of drug development, Curi aims to help pharmaceutical partners develop safer and more effective therapeutics in less time, at lower cost. Curi Bio is currently partnering with several leading pharmaceutical companies to accelerate the development of the Mantarray platform and to apply it to drug discovery and development projects.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200915005905/en/

A 3D engineered muscle tissue in Curis Mantarray platform. (Graphic: Business Wire)

Cardiovascular diseases often involve a gradual loss of cardiac contractile strength and function, ultimately leading to heart failure. Cardiomyocytes derived from human induced pluripotent stem cells (iPSC-CMs) offer a promising route to model the contractile deficiencies seen in the hearts of patients with cardiovascular diseases. However, 2D cell models lack the physiologically relevant structure and function of 3D models. As a result, 3D engineered muscle tissues have been growing in use in the drug development industry. Yet existing 3D EMT solutions are complex and low throughput, often relying on laborious serial optical imaging of each tissue to measure contractility.

Curi will make the Mantarray platform available to pharmaceutical and research customers as a standalone bioscience instrument together with multiwell consumable plates for casting and assaying EMTs. Curi will also offer service contracts and partnerships leveraging the Mantarray technology for applications in drug discovery, disease modeling, and safety and efficacy screening. Curis Mantarray platform leverages a proprietary, label-free, non-optical, electromagnetic measurement system for direct contractility assessment of up to 24 parallel iPSC-derived 3D engineered muscle tissues simultaneously. With the Mantarray platform, scientists can achieve clinically relevant functional measurements of human iPSC-derived engineered muscle tissue contractility, with a throughput and reproducibility compatible with higher-throughput screening workflows. Mantarray brings clinically relevant functional data into the earliest stages of preclinical testing of new medicines.

Leveraging human iPSC-derived cells, Mantarray 3D tissues can be used to create high-fidelity models of human diseases. For example, Mantarray 3D EMTs can be gene-edited with a CRISPR/Cas9 system to model human diseases such as Duchenne muscular dystrophy and various cardiomyopathies. Multi-modal Mantarray data show enhanced disease stratification providing researchers with more physiological data for the discovery and validation of new therapeutics.

The Mantarray platform also provides a breakthrough cardiotoxicity safety and efficacy testing platform with novel magnetic detection of drug-induced contractile changes. The magnetic detection approach can measure both acute and chronic drug responses. Drugs can be measured on the order of seconds to minutes with enough sensitivity to measure dose-response-like behavior. Alternatively, longer-term chronic experiments can be performed over the course of days. Applications include acute and chronic structural cardiotoxicity evaluation.

At Curi Bio, our goal is to provide researchers with innovative human-relevant cells, systems, and data to accelerate the discovery of new medicines, said Curi CEO Michael Cho. By providing drug developers unprecedented access to clinically-relevant preclinical models that more closely recapitulate human cardiac and skeletal muscle tissue, Curi is closing the gap between preclinical results and clinical impact.

Dr. Nicholas Geisse, Chief Science Officer of Curi Bio, will present Curis Mantarray platform and Curis recently announced ComboMat platform in a presentation at the Discovery on Target 2020 Virtual Conference.

Event: Discovery on Target 2020Date: Thursday, September 17, 2020Time: 11:15 AM EDTSession: Disease ModelingTitle: Structural Maturation in the Development of hiPSC-Cardiomyocyte Models for Preclinical Safety, Efficacy, and Discovery

Curis Mantarray platform integrates proprietary methods and IP exclusively licensed to Curi Bio by the University of Washington.

To learn more about how the Mantarray platform can improve the predictive power of 3D EMTs, or about Curis other human-relevant preclinical platform technologies and services, please reach out at http://www.curibio.com/contact.

About Curi Bio

Curi Bios preclinical discovery platform combines human stem cells, systems, and data to accelerate the discovery of new medicines. The Curi Engine is a seamless, bioengineered platform that integrates human iPSC-derived cell models, tissue-specific biosystems, and AI/ML-enabled phenotypic screening data. Curis suite of human stem cell-based products and services enable scientists to build more mature and predictive human iPSC-derived tissueswith a focus on cardiac, musculoskeletal, and neuromuscular modelsfor the discovery, safety testing, and efficacy testing of new drugs in development. By offering drug developers an integrated preclinical platform comprising highly predictive human stem cell models to generate clinically-relevant data, Curi is closing the gap between preclinical data and human results, accelerating the discovery and development of safer, more effective medicines.

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Curi Bio Announces Mantarray Platform for Analysis of 3D Engineered Muscle Tissues for Discovery of New Therapeutics - BioSpace

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