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BioRestorative Therapies Inc (OTCMKTS: BRTXQ) (BRTX) is soaring up the charts after it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. BRTXQ came to the attention of many penny stock speculators after the Company partnered on a new bankruptcy reorganization plan with one of its creditors Auctus Capital in which it would emerge from bankruptcy with the commons intact, ready to begin phase 2 trials and get BioRestorative back on a national stock exchange.

BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders.

BioRestorative Therapies Inc (OTCMKTS: BRTX) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders: Disc/Spine Program (brtxDISC): Its lead cell therapy candidate, BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders.

The BRTX-100 production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure, BRTX-100 is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. The Company has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs.

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Metabolic Program (ThermoStem): the Company is developing a cell-based therapy to target obesity and metabolic disorders using brown adipose (fat) derived stem cells to generate brown adipose tissue (BAT). BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in the body may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.

BioRestorative owns a valuable intelectual property portfolio including unique international Stem Cell patents as well as 8 patents issued, in the United States and other countries, for the Companys brown fat technology related to BioRestoratives metabolic program (ThermoStem Program).

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BioRestorative Therapies is making a powerful move up the charts after it was it was revealed at 12.04 pm Wednesday afternoon the Company was emerging from bankruptcy. This comes after the Company successfully entered into a reorganization plan with one of its creditors Auctus Capital after its March Bankruptcy filing in which the Company would emerge from bankruptcy with the commons intact, ready to begin their phase 2 trials and get BioRestorative back on a national stock exchange. BioRestorative Therapies has received authorization from the Food and Drug Administration to commence a Phase 2 clinical trial using BRTX-100 to treat persistent lower back pain due to painful degenerative discs. BRTX-100, is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. It is the Companys intend that the product be used for the non-surgical treatment of painful lumbosacral disc disorders. We will be updating on BioRestorative when more details emerge so make sure you are subscribed to Microcapdaily so you know whats going on with BioRestorative.

Disclosure: we hold no position in BRTX either long or short and we have not been compensated for this article.

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BRTX-100; the Story of BioRestorative Therapies Inc (OTCMKTS: BRTX) - MicroCap Daily

Bone Marrow Stem Cells Comments Off on BRTX-100; the Story of BioRestorative Therapies Inc (OTCMKTS: BRTX) – MicroCap Daily | November 20th, 2020

For the first time, researchers at the Center for Cell-Based Therapy (CTC) in Ribeiro Preto, Brazil, have identified a non-hereditary mutation in blood cells from a patient with GATA2 deficiency.

GATA2 deficiency is a rare autosomal disease caused by inherited mutations in the gene that encodes GATA-binding protein 2 (GATA2), which regulates the expression of genes that play a role in developmental processes and cell renewal.

An article on the study is publishedin the journalBlood.

The non-hereditary mutation may have acted as a natural gene therapy which prevented the disease from damaging the process of blood cell renewal. This meant that the patient did not develop such typical clinical manifestations as bone marrow failure, hearing loss, and lymphedema.

The researchers say that the findings pave the way for the use of gene therapy and changes to the process of checking family medical history and medical records for families with the hereditary disorder.

Luiz Fernando Bazzo Catto, first author of the article, said: When a germline [inherited] mutation in GATA2 is detected, the patients family has to be investigated because there may be silent cases.

The discovery was made when two sons were receiving medical treatment at the blood centre of the hospital run by FMRP-USP, both of which, in post-mortem DNA sequencing, showed germline mutations and GATA2 deficiency diagnosis. The researchers used next generation sequencing to estimate the proportion of normal blood cells in the fathers bone marrow, preventing clinical manifestations of GATA2 deficiency, and of cells similar to his childrens showing that 93% of his leukocytes had the mutation that protects from the clinical manifestations of GATA2 deficiency.

Following the sequencing of the fathers T-lymphocytes, the researchers found that the mutation occurred early in their lives and in the development of hematopoietic stem cells, which have the potential to form blood.

They also measured the activity of the blood cells, to see if they could maintain the activity of inducing normal cell production for a long time, by measuring the telomeres of his peripheral blood leukocytes. Telomeres are repetitive sequences of non-coding DNA at the tip of chromosomes that protect them from damage. Each time cells divide, their telomeres become shorter. They eventually become so short that division is no longer possible, and the cells die or become senescent.

The telomeres analysed by the researchers were long, indicating that the cells can remain active for a long time.

The researchers hypothesised that the existence of the somatic mutation in the fathers blood cells, and its restoration of the blood cell renewal process, may have contributed to the non-manifestation of extra-haematological symptoms of GATA2 deficiency such as deafness, lymphedema, and thrombosis.

Professor Rodrigo Calado, a corresponding author of the article, said: A sort of natural gene therapy occurred in this patient. Its as if he embodied an experiment and a medium-term prospect of analogous gene therapy treatment in patients with GATA2 deficiency.

The findings help us understand better how stem cells can recover by repairing an initial genetic defect.

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Non-hereditary mutation acts as natural gene therapy for GATA2 deficiency - Health Europa

Bone Marrow Stem Cells Comments Off on Non-hereditary mutation acts as natural gene therapy for GATA2 deficiency – Health Europa | November 18th, 2020

Chamber Member Update

Boca Raton, FL, November 17 Every three minutes a person in the United States is diagnosed with a blood disease such as leukemia, immunodeficiencies and sickle cell. To deliver cutting-edge, lifesaving therapy services for stem cell transplantations and improve patient outcomes, the Gift of Life Marrow Registry has announced the newly opened the Gift of Life Center for Cell and Gene Therapy.

Located at Gift of Lifesheadquarters in Boca Raton, Fla., theCenter will provide transplant physicians, researchers, and cell and gene therapy developers with the donor cell products they need to help more patients than ever before. One of the Centers signature services will be a biobank of off-the-shelf, on-demand cell therapy products available for transplantation, as well as those for engineering and ethical research. The inventory will be comprised of products collected from super donors with high frequency genetic characteristics sourced from the Gift of Life Marrow Registry. These cells will be tested, processed and cryopreserved by the Centers cellular therapy laboratory.

Another specialty service is the Centers innovation program, which will collaborate with world-renowned South Florida research institutions to improve transplant outcomes, develop processes for cell expansion and much more.

While many advancements have been made in stem cell treatments for those with blood diseases, there are still critical barriers that can impeded success, said Gift of Life CEO and Founder Jay Feinberg.

The only registry in the world started and run by a transplant survivor, Gift of Life has pioneered key innovations in the stem cell transplantation and donation process. Last April, the organization become the first registry to operate an in-house stem cell collection center that has not only helped to bring stem cell donors to collection faster, but also greatly improves the experience for donors. Gift of life is also the first registry to use buccal cheek swabs at recruitment drives instead of blood draws and the first to do mobile registration, including the creation of a smart phone app to register individuals quickly and effectively.

Gift of Lifes overarching mission isto democratize celltherapy and ensure that every patient has an equal opportunity to receive the treatment that can save their lives, said Feinberg. Doing so requires innovation, passion and an entrepreneurial approach to the challenges at hand and we are excited to draw upon our 30 years of expertise as we embark on this next phase of our work.

About Gift of Life Marrow RegistryGift of Life Marrow Registry is a 501(c)(3) nonprofit organization headquartered in Boca Raton, Fla. The organization, established in 1991, is dedicated to saving lives by facilitating bone marrow and blood stem cell transplants for patients with leukemia, lymphoma, and other blood-related diseases. To learn more about Gift of Life Marrow Registry, visitwww.giftoflife.org.

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gift of life marrow registry announces new center for cell and gene therapy - The Boca Raton Tribune

Bone Marrow Stem Cells Comments Off on gift of life marrow registry announces new center for cell and gene therapy – The Boca Raton Tribune | November 18th, 2020

A succinct analysis of market size, regional growth and revenue projections for the coming years is presented in GlobalStem Cells Marketreport. The study further sheds light on major issues and the new growth strategies implemented by manufacturers that are part ofcompetitive landscape of the studied market.Thereport offers key trends, investment opportunities and drivers in Global Stem Cells Marketwith the latest market intelligence by adopting primary and secondary research methods. It also includes strategies adopted in the context of acquisitions and mergers, and business footprint extensions.

In order to provide more exactmarket forecast, the report comprises a complete research study and analysis ofCOVID-19 impact on the Global Stem Cells market. It also considers the strategies that can be adopted to deal with the situation.

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Competitive Landscape and Stem Cells Market Share Analysis:

The competitive landscape of the Stem Cells market provides data about the players operating in the studied market. The report includes a detailed analysis and statistics onprice, revenue and market share of the playersfor the period 2020-2025. The major players covered are as follows:

Thermo Fisher Scientific Inc.

Cellular Engineering Technologies Inc

Qiagen N.V

Sigma Aldrich Corporation

Becton, Dickinson and Company

Miltenyi Biotec

International Stem Cell Corporation

Stem Cell Technologies Inc.

Pluristem Therapeutics Inc

Medtronic, Inc

Zimmer Holdings, Inc.

Bio Time Inc

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Orthofix, Inc.

Osiris Therapeutics Inc

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Adult Stem Cells

Neural Stem Cells

Hematopoietic Stem Cells

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Apheresis

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Biotechnology Industry

Research Institutes

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Allogeneic Stem Cell Therapy

Auto logic Stem Cell Therapy

Syngeneic Stem Cell Therapy

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Private

By Region:

North America (U.S. & Canada)

Europe (Germany, United Kingdom, France, Italy, Spain, Russia, and Rest of Europe)

Asia Pacific (China, India, Japan, South Korea, Indonesia, Taiwan, Australia, New Zealand, and Rest of Asia Pacific)

Latin America (Brazil, Mexico, and Rest of Latin America)

Middle East & Africa (GCC, North Africa, South Africa, and Rest of Middle East & Africa)

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Some Important Highlights from the Report include:

Market CAGR during the 2020-2025 forecast period.

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Precise forecasts for future developments in the Stem Cells industry and shifts in consumer behavior.

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The Following are the Key Features of Global Stem Cells Market Report:

Market Overview, Industry Development, Market Maturity, PESTLE Analysis, Value Chain Analysis

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Stem Cells Market Detailed Analysis by On-going Trends, Prominent Size, Share, Sales and Forecast to 2025 - PRnews Leader

Bone Marrow Stem Cells Comments Off on Stem Cells Market Detailed Analysis by On-going Trends, Prominent Size, Share, Sales and Forecast to 2025 – PRnews Leader | November 18th, 2020

Experts diagnose someone with a blood cancerapproximately every three minutes in the United States. Every year, new blood cancer reports account for10 percent of new diagnoses of cancer.

There are typically three separate types of blood cancers, according toExpress.co.uk. These include leukemia, lymphoma, and myeloma. Signs and symptoms vary based on the form of blood cancer an individual has.

Major factors in leukemia survival rates include early diagnosis and management. Read on to find out more about some of the signs of early blood cancer that you can never miss.

(Photo : Dan Kitwood/Getty Images/Cancer Research UK)CAMBRIDGE, UNITED KINGDOM - DECEMBER 09: A fridge of chemical solutions which contain nutrients that are needed to 'feed' cells and keep them alive for laboratory experiments, at the Cancer Research UK Cambridge Institute on December 9, 2014 in Cambridge, England. Cancer Research UK is the world's leading cancer charity dedicated to saving lives through research. Its vision is to bring forward the day when all cancers are cured. They have saved millions of lives by discovering new ways to prevent, diagnose and treat cancer, and as such the survival rate in the UK has doubled in the last 40 years. Cancer Research UK funds over 4,000 scientists, doctors and nurses across the UK, more than 33,000 patients who join clinical trials each year and a further 40,000 volunteers that give their time to support the work.

According toHematology.org, most blood cancers begin in the bone marrow - where blood is made. These cancers disrupt the development and work of your blood. The stem cells transform into three types of blood cells-white, red, or platelets in the bone marrow.

When anyone has blood cancer, and irregular blood cell's development influences the regular output of blood cells. These cancer cells inhibit the regular functions of your blood such as preventing excessive bleeding or combating diseases. There are three major types of tumors in the blood: leukemia, lymphoma, and myeloma.

Leukemia is a disease that induces the massive development of irregular white blood cells in your blood marrow. This stops bacteria from being combated by the body. These cells often hinder platelets and red blood cells from being formed by the bone marrow.

Plasma cell cancer is myeloma. The antibodies in your body are produced by these white blood cells to combat and resist illnesses and diseases. This cancer can disrupt the immune system of your body and render you susceptible to infection.

Lymphoma hinders the lymphatic function that generates immune cells and removes the body from surplus fluids. Abnormal lymphocytes, along with other cells, can accumulate and gather in the lymph nodes. The body's immune system is weakened by these cancerous cells.

Blood cancer signs differ, like leukemia. Here are certain signs of blood cancer that you can look out for. Many of these signs may sound like the flu and maybe simple to ignore.

If the body produces leukemia, blood cells are destroyed by the disease, so it is impossible for your body to produce safe blood cells. You can experience anemia, and light skin is one of the major signs of anemia. Also, your hands can feel cold to the touch.

A typical symptom in certain diseases is exhaustion. You can see the doctor if you feel more worn out than usual and note a drastic difference in your energy.

Your blood cells aid the functioning of the immune system. The body's immune system does not normally work when certain cells are unhealthy, leading you to get sick more frequently. Frequent fevers and pneumonia are some of the most prominent first signs of leukemia.

You can also keep an eye on any shortness of breath if you are feeling energy depleted. You can take care if you feel short of breath any more quickly during physical exercise.

You can bleed more than usual because the body does not produce enough platelets. You might even more often get a bloody nose. Other modifications connected to your blood that you can look out for include:

No one is sure of what induces leukemia or other cancers of the blood, and there is no means of stopping it. Many factors in the environment, including smoking, pollution, and radiation, may lead to this disease's growth. The past of the family may also play a part in your chance of leukemia.

ALSO READ: Coronavirus Survivors Twice as Likely to Develop Mental Disorders - Study

Check out more news and information on Medicine and Healthon Science Times.

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Blood Cancer: Science Reveal Five Easily Missed Signs of Leukemia - Science Times

Bone Marrow Stem Cells Comments Off on Blood Cancer: Science Reveal Five Easily Missed Signs of Leukemia – Science Times | November 18th, 2020

This article was originally published here

Stem Cells Transl Med. 2020 Nov 14. doi: 10.1002/sctm.20-0385. Online ahead of print.

ABSTRACT

Anti-inflammatory and immune-modulatory therapies have been proposed for the treatment of COVID-19 and its most serious complications. Among others, the use of mesenchymal stromal cells (MSCs) is under investigation given their well-documented anti-inflammatory and immunomodulatory properties. However, some critical issues regarding the possibility that MSCs could be infected by the virus have been raised. Angiotensin-converting enzyme 2 (ACE2) and type II transmembrane serine protease (TMPRSS2) are the main host cell factors for the Severe Acute Respiratory Syndrome-Coronavirus 2 (SARS-CoV-2) entry but so far it is unclear if human MSCs express or do not these two proteins. To elucidate these important aspects, we evaluated if human MSCs from both fetal and adult tissues constitutively express ACE2 and TMPRSS2 and, most importantly, if they can be infected by SARS-CoV-2. We evaluated human MSCs derived from amnios, cord blood, cord tissue, adipose tissue and bone marrow. ACE2 and TMPRSS2 were expressed by the SARS-CoV-2-permissive human pulmonary Calu-3 cell line but not by all the MSCs tested. MSCs were then exposed to SARS-CoV-2 wild strain without evidence of cytopathic effect. Moreover, we also excluded that the MSCs could be infected without showing lytic effects since their conditioned medium after SARS-CoV-2 exposure did not contain viral particles. Our data, demonstrating that MSCs derived from different human tissues are not permissive to SARS-CoV-2 infection, support the safety of MSCs as potential therapy for COVID-19. AlphaMed Press 2020 SIGNIFICANCE STATEMENT: Human mesenchymal stromal cells (hMSCs) are currently under investigation for the treatment of COVID-19. However, the potential safety profile of hMSCs in this context has never been defined since none has described if they express ACE2 and TMPRSS2, the main host cell factors for SARS-CoV-2 entry, and if they can be infected by SARS-CoV-2. We provide the first evidence that ACE2 and TMPRSS2 are not expressed in hMSCs derived from both adult and fetal human tissues and, most importantly, that hMSCs are not permissive to SARS-CoV-2 infection. These results support the safety of MSCs as potential therapy for COVID-19.

PMID:33188579 | DOI:10.1002/sctm.20-0385

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Human mesenchymal stromal cells do not express ACE2 and TMPRSS2 and are not permissive to SARS-CoV-2 infection - DocWire News

Bone Marrow Stem Cells Comments Off on Human mesenchymal stromal cells do not express ACE2 and TMPRSS2 and are not permissive to SARS-CoV-2 infection – DocWire News | November 18th, 2020

During a 2018 home game against Washington State University, David Shaw, Stanford's football coach, ambled slowly along the sideline, his joints aching.

Wanting to focus on the players and the game, he kept the reason for his lethargy to himself. But two years later, this past Saturday, the sports world learned the full story.

A College GameDay feature on ESPN revealed that the morning before the game, Shaw had been given stem-cell-inducing medication at Stanford Hospital. It was a first step in donating the cells to his brother, Eric Shaw, who was fighting a rare form of lymphoma.

In the opening of the six-minute video, Shaw says he thought, "'God, I hope this works, 'cause if it doesn't, I'm going to lose my brother.'"

Eric Shaw began noticing strange dark patches on his skin in 2011, the year his older brother became Stanford's head football coach. They were everywhere, from head to foot. Later, small tumors popped up all over his body.

"I would have itching attacks where I would end up actually tearing my skin," he says in the video. "I would still scratch at night and end up with bloody arms and legs."

Eric Shaw transferred his medical care to the Stanford Cancer Center in 2013. There, physicians told the financial services marketing professional that he needed to start radiation treatment immediately. It worked, but only briefly: Six months later, the cancer returned.

He was diagnosed with mycosis fungoides, a T cell lymphoma that affects fewer than four in a million people in the United States.

Shaw's physicians began discussing bone marrow transplant. David Shaw was tested as a donor, but he scored only 5 on a 10-point match scale. A worldwide search found closer matches, and Eric Shaw underwent radiation and chemotherapy to prepare for the transplant.

One attempt failed, then another.

"You think you've kind of pulled at the last thread, and there are no more threads, and all I could tell him was that I loved him and that I was there for him," David Shaw says in the video.

But the Stanford physicians had one last weapon: a haploidentical transplant. The recently developed technique uses stem cells, typically from a family member, that are less than a perfect match.

David Shaw underwent a five-day-long process at Stanford Hospital to donate the cells. He received medication that caused him to produce an abundance of stem cells, then gave blood from which the cells were extracted. Those cells were then transplanted into his brother.

This time, it worked.

After 52 days at Stanford Hospital, Eric Shaw finally went home on Nov. 25, 2018. The video shows him being wheeled out as medical staff members cheer him on.

Youn Kim, MD, who treated Eric and heads Stanford's multidisciplinary Cutaneous Lymphoma Clinic/Program, told ESPN: "If he didn't go for this risk, he wouldn't be here...He wouldn't be living."

As the article notes, Stanford physicians Wen-Kai Weng, MD, PhD, and Michael Khodadoust, MD, PhD, also were on the team treating Eric Shaw.

Today, nearly two years later, he remains cancer-free.

"Seven years of battling this disease, and it was over," he says in the video, tears running down his face. "A miracle."

David Shaw shares his brother's joy. As he told ESPN: "Every time I see him, I just smile, you know? Because he gets to be here."

Images of Eric Shaw, left, taken earlier this month, and his brother David Shaw, courtesy of the Shaw family, and Stanford Athletics

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Stanford coach's quest to save his brother: 'God, I hope this works' - Scope

Bone Marrow Stem Cells Comments Off on Stanford coach’s quest to save his brother: ‘God, I hope this works’ – Scope | November 16th, 2020

MILAN, Italy and NEW YORK, Nov. 16, 2020 (GLOBE NEWSWIRE) -- Genenta Science, a clinical-stage biotechnology company pioneering the development of hematopoietic stem progenitor cell immuno-gene therapy for cancer (Temferon), presents new preliminaryclinical data from a Phase I/IIa study of Temferon in patients affected by glioblastoma multiforme (GBM) at the 2020 Society for Neuro-Oncology (SNO) Annual Meeting, taking place November 19-22 in Austin, TX.

To date, ten patients were enrolled and eight were treated. Temferon was well tolerated, as suggested by the rapid hematological recovery and engraftment of modified cells observed in all the treated patients. No dose limiting toxicities were identified.

T-cell immunorepertoire changes were observed after treatment with evidence for clonal expansion, including tumor associated clones, suggesting a possible reset of T-cell responses, which are known to play a key role in the tumor-induced tolerance.

Interferon-alpha (IFN-) response was identified across a number of tumor infiltrating myeloid cells while a low concentration of IFN- was detected in the plasma and cerebrospinal fluid (CSF) of patients. This provides evidence that the Temferon built-in control mechanism is working to reduce the risk of IFN- off-target effects preserving the desired in situ biological effects.

Pierluigi Paracchi, Chairman and Chief Executive Officer at Genenta Science, said: These preliminary results are exciting indications of the feasibility, safety and local biological activity of our approach. The data are encouraging and in line with our pre-clinical results, with preliminary evidence of changes in the immune system and that Temferon is well tolerated without systemic toxicities.

Temferon-derived differentiated cells, as determined by vector copy number (VCN) in peripheral blood and bone marrow, were evident within 14 days of treatment and persist in peripheral blood in the long term (up to one year). Preliminary data on tumor specimens at second surgery confirmed the presence of TEMs and suggested that a higher IFN response gene signature may occur after treatment in stable lesions, compared to lesions that progress.

About Genenta Science

Genenta (www.genenta.com) is a clinical-stage biotechnology company pioneering the development of a proprietary hematopoietic stem cell gene therapy for cancer. Temferon is based on ex-vivo gene transfer into autologous hematopoietic stem/progenitor cells (HSPCs) to deliver immunomodulatory molecules directly via tumor-infiltrating monocytes/macrophages (Tie2 Expressing Monocytes - TEMs). TemferonTM, which is under investigation in a Phase I/IIa clinical trial in newly diagnosed Glioblastoma Multiforme patients, is not restricted to pre-selected tumor antigens nor type and may reach solid tumors, one of the main unresolved challenge in immuno-oncology. Based in Milan, Italy, and New York, USA, Genenta has raised more than 33.6 million (~$40 million) in three separate rounds of financing.

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Genenta's Temferon: Evidence of Controlled and Targeted Interferon Expression in Preliminary Phase I/II Clinical Data in Glioblastoma MultiformeData...

Bone Marrow Stem Cells Comments Off on Genenta’s Temferon: Evidence of Controlled and Targeted Interferon Expression in Preliminary Phase I/II Clinical Data in Glioblastoma MultiformeData… | November 16th, 2020

Paula Grisanti, Opinion contributor Published 6:20 a.m. ET Nov. 9, 2020

This year, Nov.17 has been designated World Cord Blood Day, an annual event to raise awareness for the life-saving benefits of cord blood transplants while educating parents, health professionals and the general public about the need to preserve these precious cells.

Cord blood transplants are being used to treat more than 80 different diseases and conditions including blood cancers like leukemia and lymphoma, neuroblastoma (the most common cancer in infants), bone-marrow failure disorders, inherited blood disorders and rare immune system disorders. They are also showing new promise for conditions that have never had treatment options, like autism and brain injury.

The first cord blood stem cell transplant, an international effort between physicians in the U.S. and Europe, was performed in France in 1988. Stem cells collected from a newborns umbilical cord blood were used to save the life of her brother, a 5-year-old with Fanconi Anemia. Since then, there have been more than 40,000 cord blood transplants performed worldwide.

Now standard of care for cancers of the blood and a host of other life-threatening diseases, blood forming stem cells for transplantation can be collected from bone marrow, circulating bloodor a newborn babys umbilical cord blood. Some experts believe cord blood contains nearly 10 times the number of stem cells found in bone marrow.

Because umbilical cord stem cells are less mature than adult bone marrow stem cells, they are also less likely to be rejected and can be used when there isnt a perfect match.

Between these threeoptions, the easiest collection by far is from umbilical cord and placental tissue after a baby is born and the umbilical cord has been cut, at no risk to mother or child, in a process that typically takes 5 to 10 minutes. The cells are then frozen in liquid nitrogen and can be stored indefinitely in private or public cord blood banks.

To store your babys cord blood for use by your child and your family only, you make arrangements with a private cord blood bank ahead of delivery to collect and store the cells; the cost to you includes a collection fee of $1,500 to $2,000 and an annual storage fee of $100 to $125.

If you cant afford or dont wish to save your babys cord blood stem cells, you can donate them to a public cord blood bank at no cost to you or your family.

Its the equivalent of registering these potentially life-saving cells with the national bone marrow registry; they will be available to the families of other children who need to find a bone marrow match after a devastating diagnosis. Without information and education, however, 95% of all cord blood is discarded as medical waste.

Right now, there is no public cord banking option in Kentucky, although public cord blood banking is highly recommended by both the American Academy of Pediatrics (AAP) and the American Medical Association (AMA). There are fewer than 25 public or hybrid cord blood banks in the U.S., many limited to a specific geographic area. None of them include Kentucky.

The chances of finding a bone marrow match in your family are only about 25%, making the bone marrow and umbilical cord blood registries a lifeline in desperate situations. Odds are worse for African Americans and other ethnic minorities who are underrepresented on the registry and ethnicity matters in a bone marrow transplant.

Donating cord blood cells to a public bank adds to the library of cells that may save someones life and increases the chance of a match for all of us. Who benefits most? Children, patients with rare human leukocyte antigen (HLA) types and ethnic minorities.

We need to do two things: Make public cord blood banking an option in the commonwealth of Kentucky, and then encourage conversations between health care providers and expectant parents about preserving these life-saving cells.

There are 28 states with legislation that ask or mandates physicians to talk to expectant parents about cord blood banking. Kentucky is not one of them, but most of our surrounding states have such legislation in place.

Through a long-standing relationship between the National Stem Cell Foundationand world-renowned cord blood expert Dr. Joanne Kurtzberg, we have a path forward for training hospitals and collecting cells for storage at the Carolinas Cord Blood Bank (CCBB), one of the largest public cord blood banks in the world. Dr. Kurtzberg directs both the Pediatric Blood and Marrow Transplant (PBMT) program at Duke University and the CCBB.

She performed the worlds first unrelated cord blood transplant in 1993, paving the way for this now routine source of donor cells for children who need a bone marrow transplant and dont have a matched donor. She established the CCBB in 1998.

Paula Grisanti is CEO of the National Stem Cell Foundation.(Photo: provided)

While weve initiated discussions between Louisville hospital systems and the CCBB, we need to begin the process of education for parents, nursing and medical school students, residents, midwives, practicing OB-GYNs and the general public.

What a waste to discard these life-saving cells the future of current and developing therapies for disabling and life-threatening diseases depends on our ability to make sure that doesnt happen.

Dr. Paula Grisanti is CEO and a founding member of the National Stem Cell Foundation, headquartered in Louisville, Kentucky. She holds a D.M.D. and MBA from the University of Louisville and has been actively involved in new venture start-ups for most of her career.

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It's time for Kentucky to talk to expectant parents about benefits of cord blood banking - Courier Journal

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NEW YORK, Nov. 11, 2020 /PRNewswire/ --Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) ("Actinium") today announced that it will host a CD33 program update featuring two key opinion leaders (KOLs) today, November 11th at 4:15 PM ET. The event will feature KOLs Dr. Ehab Atallah from the Medical College of Wisconsin, the senior investigator of the Actimab-A CLAG-M combination trial and Dr. Gary Schiller from the University of California Los Angeles Health, the principal investigator for the Actimab-A venetoclax combination trial as well as members of Actinium's management team. Both KOL's will review data that was included in abstracts accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting. They will also provide their perspectives on the treatment landscape and medical need each trial potentially addresses.

Actimab-A AML Combinations Update Call DetailsWebcast link:https://ir.actiniumpharma.com/presentations-webinarsDate: November 11, 2020Time: 4:15 PM ET

Dr. Ehab Atallah, MD, is a Professor of Medicine and Section Head of Hematological Malignancies at the Medical College of Wisconsin Division of Hematology and Oncology, specializing in leukemia and myelodysplastic syndromes at Froedtert Hospital. Dr Atallah, as senior investigator, will review the Phase 1 data from the Actimab-A CLAG-M combination trial in relapsed or refractory acute myeloid leukemia (R/R AML) that demonstrated 100% remission in the third and planned final dose cohort. Further, 83% of patients (10/12) who received 3 or fewer prior lines of treatment achieved CR or CRi. Notably, 70% of CR/CRi patients (7/10) were MRD negative indicating a deep remission with no detectable disease. Dr. Atallah will also discuss the trial data in the context of data available for other treatment options, including recently approved and novel agents in development, in the fit R/R AML population.

Dr. Gary Schiller, MD, is the Director of Bone Marrow/Stem Cell Transplantation and Professor of Hematology-Oncology at UCLA. Dr. Schiller, a well-published clinical investigator in acute and chronic leukemias and other hematologic malignancies, is the principal investigator on the Phase 1/2 clinical trial of Actimab-A and venetoclax. Dr. Schiller will discuss the lack of viable treatment options for R/R AML and the available opportunity for combination regimens such as Actimab-A plus venetoclax. Last week, the company announced that first-in-human data in this combination trial had been accepted for poster presentation at ASH in December. The trial is in the dose escalation phase with proof of concept data expected in 2021.

CD33 Program ASH Abstract Links

Oral Presentation Title: A Phase I Study of Lintuzumab Ac225 in Combination with CLAG-M Chemotherapy in Relapsed/Refractory AMLPublication Number: 165Link: https://ash.confex.com/ash/2020/webprogram/Paper137218.html

Poster Title: Lintuzumab-225Ac in Combination with Venetoclax in Relapsed/Refractory AML: Early Results of a Phase I/II StudyPublication Number: 2875Link: https://ash.confex.com/ash/2020/webprogram/Paper141132.html

About Actinium's CD33 Program

Actinium's CD33 program is evaluating the clinical utility of Actimab-A, an ARC comprised of the anti-CD33 mAb lintuzumab linked to the potent alpha-emitting radioisotope Actinium-225 or Ac-225. CD33 is expressed in the majority of patients with AML and myelodysplastic syndrome, or MDS, as well as patients with multiple myeloma. The CD33 development program is driven by data from over one hundred and twenty-five treated patients, including a Phase 1/2 trial where Actimab-A produced a remission rate as high as 69% as a single agent. This clinical data is shaping a two-pronged approach for the CD33 program, where at low doses the Company is exploring its use for therapeutic purposes in combination with other modalities and at high doses for use for targeted conditioning prior to bone marrow transplant.Actinium currently has multiple clinical trials ongoing including the Phase 1 Actimab-A CLAG-M and Phase 1/2 Actimab-A venetoclax combination trials and is exploring additional CD33 ARC combinations with other therapeutic modalities such as chemotherapy, targeted agents or immunotherapy.

About Actinium Pharmaceuticals, Inc. (NYSE: ATNM)

Actinium Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company developing ARCs or Antibody Radiation-Conjugates, which combine the targeting ability of antibodies with the cell killing ability of radiation. Actinium's lead application for our ARCs is targeted conditioning, which is intended to selectively deplete a patient's disease or cancer cells and certain immune cells prior to a BMT or Bone Marrow Transplant, Gene Therapy or Adoptive Cell Therapy (ACT) such as CAR-T to enable engraftment of these transplanted cells with minimal toxicities. With our ARC approach, we seek to improve patient outcomes and access to these potentially curative treatments by eliminating or reducing the non-targeted chemotherapy that is used for conditioning in standard practice currently. Our lead product candidate, I-131 apamistamab (Iomab-B) is being studied in the ongoing pivotal Phase 3 Study of Iomab-B in Elderly Relapsed or Refractory Acute Myeloid Leukemia (SIERRA) trial for BMT conditioning. The SIERRA trial is over seventy-five percent enrolled and positive single-agent, feasibility and safety data has been highlighted at ASH, TCT, ASCO and SOHO annual meetings. More information on this Phase 3 clinical trial can be found at sierratrial.com. I-131 apamistamab will also be studied as a targeted conditioning agent in a Phase 1 study with a CD19 CAR T-cell Therapy and Phase 1/2 anti-HIV stem cell gene therapy with UC Davis. In addition, we are developing a multi-disease, multi-target pipeline of clinical-stage ARCs targeting the antigens CD45 and CD33 for targeted conditioning and as a therapeutic either in combination with other therapeutic modalities or as a single agent for patients with a broad range of hematologic malignancies including acute myeloid leukemia, myelodysplastic syndrome and multiple myeloma. Ongoing combination trials include our CD33 alpha ARC, Actimab-A, in combination with the salvage chemotherapy CLAG-M and the Bcl-2 targeted therapy venetoclax. Underpinning our clinical programs is our proprietary AWE (Antibody Warhead Enabling) technology platform. This is where our intellectual property portfolio of over 100 patents, know-how, collective research and expertise in the field are being leveraged to construct and study novel ARCs and ARC combinations to bolster our pipeline for strategic purposes. Our AWE technology platform is currently being utilized in a collaborative research partnership with Astellas Pharma, Inc. Website: https://www.actiniumpharma.com/

Forward-Looking Statements for Actinium Pharmaceuticals, Inc.

This press release may contain projections or other "forward-looking statements" within the meaning of the "safe-harbor" provisions of the private securities litigation reform act of 1995 regarding future events or the future financial performance of the Company which the Company undertakes no obligation to update. These statements are based on management's current expectations and are subject to risks and uncertainties that may cause actual results to differ materially from the anticipated or estimated future results, including the risks and uncertainties associated with preliminary study results varying from final results, estimates of potential markets for drugs under development, clinical trials, actions by the FDA and other governmental agencies, regulatory clearances, responses to regulatory matters, the market demand for and acceptance of Actinium's products and services, performance of clinical research organizations and other risks detailed from time to time in Actinium's filings with the Securities and Exchange Commission (the "SEC"), including without limitation its most recent annual report on form 10-K, subsequent quarterly reports on Forms 10-Q and Forms 8-K, each as amended and supplemented from time to time.

Contacts:

Investors:Clayton RobertsonActinium Pharmaceuticals, Inc.crobertson@actiniumpharma.com

Hans VitzthumLifeSci Advisors, LLCHans@LifeSciAdvisors.com(617) 430-7578

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Actinium to Host KOL Call on November 11th Featuring Actimab-A AML Combination Trials - Salamanca Press

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

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

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

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

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

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Bone Marrow Processing System Market Industry Outlook, Growth Prospects and Key Opportunities - The Daily Philadelphian

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SAN DIEGO, Nov. 11, 2020 /PRNewswire/ -- Angiocrine Bioscience Inc., a clinical-stage biopharmaceutical company today announced that the U.S. Food and Drug Administration (FDA) granted the Regenerative Medicine Advanced Therapy (RMAT) designation for AB-205, for "the treatment of organ vascular niche injuries to prevent or reduce severe regimen-related toxicities (SRRT) in patients with Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL) undergoing high-dose therapy (HDT) and autologous hematopoietic stem cell transplantation".Based on its Phase 2 trial results, Angiocrine expects to initiate a single pivotal registration Phase 3 trial in 2021 involving leading cancer centers in North America and Europe.

Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205

"The RMAT designation speaks to the clinical meaningfulness and the promising efficacy data and safety profile of AB-205 based on our Phase 1b/2 study.This is an important step in accelerating the development of AB-205 towards its first market approval," commented Paul Finnegan, MD, Angiocrine's CEO."We appreciate the thorough assessment provided by the FDA reviewers and the support from our partner, the California Institute for Regenerative Medicine."Angiocrine was awarded a $6 million grant from CIRM in 2019 for the clinical development of AB-205.

About Regenerative Medicine Advanced Therapy (RMAT) DesignationEstablished under the 21st Century Cures Act, the RMAT designation was established to facilitate development and expedite review of cell therapies and regenerative medicines intended to treat serious or life-threatening diseases or conditions. Advantages include the benefits of the FDA's Fast Track and Breakthrough Therapy Designation programs, such as early interactions with the FDA to discuss potential surrogate or intermediate endpoints to support accelerated approval.

About HDT-AHCT High-dose therapy and autologous hematopoietic cell transplantation (HDT-AHCT) is considered a standard-of-care therapy for patients with aggressive systemic Hodgkin lymphoma (HL) and non-Hodgkin lymphoma (NHL).Although efficacious and considered a potential cure, HDT-AHCT is associated with severe regimen-related toxicities (SRRT) that increase patient morbidity and risk for mortality, especially in the aging population. Effective prevention of SRRT may lead to more patients being eligible for a potential cure through HDT and stem cell transplantation.

About SRRT Consequences of Diffuse Injury to the Organ Vascular NichesThe human body is capable of renewing, healing and restoring organs.For example, the human oral-GI tract renews its lining every 3 to 7 days. Both the organ renewal and healing processes are dependent on organ stem cell vascular niches made up of stem cells, endothelial cells (cells that line blood vessels) and supportive cells.When tissues are injured, the vascular niche endothelial cells direct the stem cells, via angiocrine factor expression, to repair and restore the damaged tissue. This restorative capacity is most active during childhood and youth but starts to diminish with increasing age.HDT provided to eradicate cancer cells also cause diffuse, collateral damage to vascular niches of multiple healthy organs. In particular, the organs with the highest cell turnover (ones with most active vascular niches) are severely affected.Specifically, the oral-GI tract, dependent on constant renewal of its mucosal lining, starts to break down upon vascular niche injury.The mucosal breakdown can cause severe nausea, vomiting and diarrhea. In addition, the bacteria in the gut may escape into the circulation, resulting in patients becoming ill with endotoxemia, bacteremia or potentially lethal sepsis.HDT-related vascular niche damage can also occur in other organs resulting in severe or life-threatening complications involving the lung, heart, kidney, or the liver.Collectively, these complications are known as severe regimen-related toxicities or SRRT.SRRT can occur as frequently as 50% in lymphoma HDT-AHCT patients, with increased rate and severity in older patients.

About AB205AB-205 is a first-in-class engineered cell therapy consisting of proprietary 'universal' E-CEL (human engineered cord endothelial) cells.The AB-205 cells are intravenously administered after the completion of HDT on the same day as when the patient's own (autologous) blood stem cells are infused. AB-205 acts promptly to repair injured vascular niches of organs damaged by HDT.By repairing the vascular niches, AB-205 restores the natural process of tissue renewal, vital for organs such as oral-GI tract and the bone marrow. Successful and prompt organ restoration can prevent or reduce SRRT, an outcome that is beneficial to quality of life and cost reductive to the healthcare system.

About CIRMThe California Institute for Regenerative Medicine (CIRM) was established in November, 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure provided $3 billion in funding for California universities and research institutions.With over 300 active stem cell programs in their portfolio, CIRM is the world's largest institution dedicated to stem cell research. For more information, visit http://www.cirm.ca.gov.

About Angiocrine Bioscience Inc.Angiocrine Bioscience is a clinical-stage biotechnology company developing a new and unique approach to treating serious medical conditions associated with the loss of the natural healing and regenerative capacity of the body.Based on its novel and proprietary E-CEL platform, Angiocrine is developing multiple therapies to address unmet medical needs in hematologic, musculoskeletal, gastrointestinal, soft-tissue, and degenerative/aging-related diseases.A Phase 3 registration trial is being planned for the intravenous formulation of AB-205 for the prevention of severe complications in lymphoma patients undergoing curative HDT-AHCT.This AB-205 indication is covered by the Orphan Drug Designation recently granted by the US FDA.In addition, Angiocrine is conducting clinical trials of local AB-205 injections for the treatment of: (1) rotator cuff tear in conjunction with arthroscopic repair; and, (2) non-healing perianal fistulas in post-radiation cancer patients.

For additional information, please contact:

Angiocrine Bioscience, Inc.John R. Jaskowiak(877) 784-8496IR@angiocrinebio.com

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Angiocrine Bioscience Announces FDA Regenerative Medicine Advanced Therapy (RMAT) Designation Granted to AB-205 (Universal E-CEL Cell Therapy) to...

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REGINA -- Saskatchewans hockey community is mourning the loss of Rick Schwartz, who died suddenly in his Regina home on Monday evening from a heart attack at age 59.

To the public, Schwartz is known as the father of a Stanley Cup champion. His son, Jaden, is a member of the St. Louis Blues who won the cup in 2019.

Schwartz is also known for the dedication that he and his wife, Carol, have for the Mandi Schwartz Foundation. It is named after their daughter who lost a public battle to cancer in 2011. The foundation has focused on advocating for bone marrow drives and donations.

However, to those closest to Schwartz, hes being remembered as a man who put family and community before anything.

FAMILYS FIRST

Ramona and Patrick Vigneron, who are long-time close family friends of the Schwartzes, say theyll remember Ricks jokes, smile and laughter the most.

And just how much he absolutely loves his family, Ramona said. He always said familys first.

Schwartz had three children: Jaden, Rylan and Mandi.

The two families would travel together, often to watch their children play hockey. Some of their trips took them to Colorado, North Dakota, St. Louis and Germany.

With the celebrations hed always include family and friends, Ramona said.

Whether it was during the kids minor hockey days in Wilcox or watching a Stanley Cup Championship, Schwartz always provided a fun time for those around him.

One of the most entertaining things you could do is watch a hockey game with Rick with one of the kids playing, Patrick said.

It was great watching games with Ricky because he got pretty emotional as he watched the boys and Mandi play, Ramona said. It was really part of Rickys life, you could just see him come to life watching the kids play.

BONE MARROW DRIVES

In honour of Mandi, the Schwartz family launched a foundation that is often involved in bone marrow drives in hopes of helping people who need a donor find their perfect match.

Rick was determined to make sure Mandis foundation continued on with the stem cells, and match program was very important, Ramona said.

Bone marrow drives continue at Yale University, where Mandi played. The St. Louis Blues also held a drive in 2013. Four years later, an 18-year-old woman was able to find her perfect match from a man who was swabbed at that Blues game.

The Schwartz family hosted both the donor and the recipient, both from the United States, in 2019 for the annual Run for Mandi in Saskatchewan.

ATHOL MURRAY COLLEGE OF NOTRE DAME

Rick and Carols three children all attended Athol Murray College of Notre Dame in their childhood and teenage years.

They participated in multiple sports, but hockey was the biggest. Its been about a decade since any of the kids played there, but the Schwartzes have always stayed involved in the community.

The great thing about Rick was that he loves hockey, Rob Palmarin, the president of Athol Murray College of Notre Dame, said. Hed still come out to our arena and would visit with our coaches who were the coaches of his sons and daughter, and our hockey staff. He was a frequent visitor to our arena so he was just one of the family.

After Mandis passing in 2011, the Schwartz family helped to honour her at the school.

The Schwartz family has set up an endowment fund and that supports a number of our female athletes, particularly hockey players, on an annual basis, Palmarin said. That came out of the tragedy of Mandi Schwartz dying of cancer in 2011. So its been almost a decade of them working to keep her memory alive.

Palmarin said Rick and Carol were role models of parents who had children playing hockey.

One of the mottos painted in the rink at Notre Dame reads Never Lose Heart.

That motto is painted up there not only as an inspiration to our student athletes when they practice and play, but its also an inspirational motto for all of us to remember the Notre Dame Hounds family, both living and deceased, Palmarin said. Rick is now going to be part of that.

RECENT MEMORIES

Most recently, Schwartz worked with the Saskatchewan Safety Council. Patrick worked there with him for the past five years.

Weve got a couple of projects on the board right now and Im not sure where theyre going to end up, but well try to make them work for him, Patrick said.

Ramona said right now, the Schwartz family is cherishing the time they were able to spend together over the summer.

One of the blessings of COVID-19 was that Rylan came home from Germany and then Jaden came home from St. Louis and they were with their parents for literally four months, Ramona said. Carol kept repeating these last few days it has been awesome how much time Rick got to spend with his sons for the last four months.

She said the memories of playing golf and cards will long be remembered by the family.

The death is a shock. Theres a lot of people who have been affected by Ricky and just how passionate he is, Ramona said. He has a heart of gold.

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'A heart of gold': Rick Schwartz remembered for his commitment to family, community - CTV News

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TAIPEI, Nov. 9, 2020 /PRNewswire/ -- TaiGen Biotechnology Company, Limited ("TaiGen") announced today that they have signed an exclusive agreement with GPCR Therapeutics, Inc. ("GPCR"), a leading Korean biotechnology company, for the continued development of Burixafor worldwide and the commercialization of Taigexyn (nemonoxacin) in South Korea.

Burixafor is a highly potent CXCR4 inhibitor currently under clinical development. It can be used as a stem cell mobilizer for hematopoietic stem cell transplantation and a chemosensitizer in hematological and solid tumors. It can also be used for stem cell collection in healthy individuals for personalized regenerative medicine. Taigexyn is a novel safe and effective antibiotic for the treatment of bacterial infections including those caused by drug-resistant bacteria.

Under the terms of the agreement, GPCR Therapeutics will be wholly responsible for the development, registration, and commercialization of Taigexyn in S. Korea and Burixafor worldwide. Apart from upfront fees, TaiGen will receive shares of GPCR Therapeutics as well as future milestone and royalty payments.

GPCR Therapeutics is a world leader in the field of GPCR heteromer science and hasproprietary expertise and technology applicable to the development of this class of anti-cancer targets. CXCR4 antagonism is a well-accepted avenue towards cancer therapy and GPCR Therapeutics is well experienced and possesses the necessary know-how to develop Burixafor in the oncology field.

Dongseung Seen, CEO of GPCR Therapeutics, said, "This collaboration with TaiGen, which is a leading biotech company engaged in innovative molecular-based platforms with strong R&D capabilities, will lead to a long-term strategic and productive partnership. Further, it is our goal that our work together will position us to be a pre-eminent developer of anti-CXCR4 oncology drugs."

Kuo-Lung Huang, Chairman and Chief Executive Officer of Licensor, said, "This agreement and collaboration with GPCR is a tremendous progress in the continued development of Burixafor. Through the collaboration with GPCR Therapeutics, a novel and effective treatment for cancer patients possessing CXCR4 heteromers is on the horizon while a highly effective antibiotic will enter the S. Korea market to address their unmet medical needs in the near future."

About Burixafor

A stem cell mobilizer, Burixafor, is TaiGen's first fully in-house developed product, a First-in-Class drug with an IND under US FDA. With a variety of potential applications in a number of disease indications, if proven effective in clinical trials, Burixafor will be able to address several unmet medical needs. The molecule is a potent and selective chemokine receptor antagonist which can rapidly mobilize stem cells and progenitor cells from the bone marrow into peripheral circulation. Burixafor also has potential application in chemosensitization treatment of leukemia patients, delaying relapse after chemotherapy.

About Taigexyn

Taigexyn is a novel non-fluorinated quinolone available in both oral and intravenous formulations. The oral formulation of Taigexyn have received market approval in Taiwan and mainland China shown activity against drug-resistant bacteria such as methicillin-resistant Staphylococcus aureus (MRSA) and quinolone-resistant MRSA as well as quinolone-resistant Streptococcus pneumonia. TaiGen partnered with Zhejiang Medicaine Co., Holding Distribution, R-Pharm of Russia, Productos Cientficos S.A. de C.V., Luminarie Canada Inc. and GPCR Therapeutics, Inc. in 36 countries worldwide. In addition to the oral formulation, TaiGen granted NDA approval for intravenous formulation in Taiwan and is going to obtain the market approval in mainland China.

About GPCR Therapeutics, Inc.

Based in Seoul, S. Korea, GPCR Therapeutics is a biopharmaceutical company developing drugs based on the novel science of GPCR (G Protein-Coupled Receptor) heteromers. GPCR Therapeutics is specifically focused on the development of cancer therapeutics with a precision oncology approach.

About TaiGen Biotechnology

TaiGen Biotechnology is a leading research-based and market-driven biotechnology company in Taiwan with a wholly-owned subsidiary in Beijing, China. In addition to Taigexyn and Burixafor, TaiGen has two other in-house discovered NCEs: TG-1000, a novel pan-influenza antiviral effective against influenza-A, influenza-B, avian flu H7N7, and Tamiflu-resistant viruses, and Furaprevir, a HCV protease inhibitor for treatment of chronic hepatitis infection. TG-1000 is currently in Phase 1 clinical study in China and is granted IND approval by FDA in the U.S., and Furaprevir is currently in Phase 3 clinical development.

SOURCE TaiGen

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VANCOUVER, Washington, Nov. 11, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (CytoDyn or the Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today it completed an additional non-dilutive convertible debt offering with an institutional investor, which provides $25 million of immediately available capital. The note has a two-year maturity, bears interest at the rate of 10% per annum and is secured by all assets of the Company, excluding its intellectual property. The note may be converted at the option of the investor into shares of the Companys common stock at a conversion price of $10.00 per share.

Nader Pourhassan, Ph.D., President and Chief Executive Officer of CytoDyn, stated, We are very pleased with the institutions demonstration of confidence and their understanding of leronlimabs positioning on its regulatory trajectory. This infusion of capital will enable us to accelerate efforts to file BLAs in Canada and the U.K. for leronlimab as a combination therapy for HIV patients with one dose (one 350 mg subcutaneous injection) per week. We continue to expedite enrollment in CD12 (currently at 260 patients), in addition to now accelerating a COVID-19 trial for long-hauler patients, who have no alternative therapy and are rapidly emerging as a widespread health concern. We are well-positioned to supply $2 billion worth of leronlimab to treat COVID-19, if emergency use authorization is approved in the next 2-4 months based on anticipated successful CD12 results.

About Coronavirus Disease 2019 CytoDyn completed its Phase 2 clinical trial (CD10) for COVID-19, a double-blinded, randomized clinical trial for mild-to-moderate patients in the U.S. which produced statistically significant results for NEWS2. Enrollment continues in its Phase 2b/3 randomized clinical trial for the severe-to-critically ill COVID-19 population in several hospitals and clinics throughout the U.S., which are identified on the Companys website under the Clinical Trial Enrollment section of the homepage; an interim analysis on the first 195 patients was conducted mid-October and is expected to occur again after enrollment reaches 293 patients.

About Leronlimab (PRO 140) The FDA has granted a Fast Track designation to CytoDyn for two potential indications of leronlimab for critical illnesses. The first indication is a combination therapy with HAART for HIV-infected patients and the second is for metastatic triple-negative breast cancer. Leronlimab is an investigational humanized IgG4 mAb that blocks CCR5, a cellular receptor that is important in HIV infection, tumor metastases, and other diseases, including NASH.Leronlimab has completed nine clinical trials in over 800 people and met its primary endpoints in a pivotal Phase 3 trial (leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients).

In the setting of HIV/AIDS, leronlimab is a viral-entry inhibitor; it masks CCR5, thus protecting healthy T cells from viral infection by blocking the predominant HIV (R5) subtype from entering those cells. Leronlimab has been the subject of nine clinical trials, each of which demonstrated that leronlimab could significantly reduce or control HIV viral load in humans. The leronlimab antibody appears to be a powerful antiviral agent leading to potentially fewer side effects and less frequent dosing requirements compared with daily drug therapies currently in use.

In the setting of cancer, research has shown that CCR5 may play a role in tumor invasion, metastases, and tumor microenvironment control. Increased CCR5 expression is an indicator of disease status in several cancers. Published studies have shown that blocking CCR5 can reduce tumor metastases in laboratory and animal models of aggressive breast and prostate cancer. Leronlimab reduced human breast cancer metastasis by more than 98% in a murine xenograft model. CytoDyn is, therefore, conducting a Phase 1b/2 human clinical trial in metastatic triple-negative breast cancer and was granted Fast Track designation in May 2019.

The CCR5 receptor appears to play a central role in modulating immune cell trafficking to sites of inflammation. It may be crucial in the development of acute graft-versus-host disease (GvHD) and other inflammatory conditions. Clinical studies by others further support the concept that blocking CCR5 using a chemical inhibitor can reduce the clinical impact of acute GvHD without significantly affecting the engraftment of transplanted bone marrow stem cells.CytoDyn is currently conducting a Phase 2 clinical study with leronlimab to support further the concept that the CCR5 receptor on engrafted cells is critical for the development of acute GvHD, blocking the CCR5 receptor from recognizing specific immune signaling molecules is a viable approach to mitigating acute GvHD. The FDA has granted orphan drug designation to leronlimab for the prevention of GvHD.

About CytoDyn CytoDyn is a late-stage biotechnology company developing innovative treatments for multiple therapeutic indications based on leronlimab, a novel humanized monoclonal antibody targeting the CCR5 receptor. CCR5 appears to play a critical role in the ability of HIV to enter and infect healthy T-cells. The CCR5 receptor also appears to be implicated in tumor metastasis and immune-mediated illnesses, such as GvHD and NASH.

CytoDyn has successfully completed a Phase 3 pivotal trial with leronlimab in combination with standard antiretroviral therapies in HIV-infected treatment-experienced patients. The FDA met telephonically with Company key personnel and its clinical research organization and provided written responses to the Companys questions concerning its recent Biologics License Application (BLA) for this HIV combination therapy in order to expedite the resubmission of its BLA filing for this indication.

CytoDyn has completed a Phase 3 investigative trial with leronlimab as a once-weekly monotherapy for HIV-infected patients. CytoDyn plans to initiate a registration-directed study of leronlimab monotherapy indication. If successful, it could support a label extension. Clinical results to date from multiple trials have shown that leronlimab can significantly reduce viral burden in people infected with HIV. No drug-related serious site injection reactions reported in about 800 patients treated with leronlimab and no drug-related SAEs reported in patients treated with 700 mg dose of leronlimab. Moreover, a Phase 2b clinical trial demonstrated that leronlimab monotherapy can prevent viral escape in HIV-infected patients; some patients on leronlimab monotherapy have remained virally suppressed for more than six years.

CytoDyn is also conducting a Phase 2 trial to evaluate leronlimab for the prevention of GvHD and a Phase 1b/2 clinical trial with leronlimab in metastatic triple-negative breast cancer. More information is at http://www.cytodyn.com.

Forward-Looking StatementsThis press release contains certain forward-looking statements that involve risks, uncertainties and assumptions that are difficult to predict. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as "believes," "hopes," "intends," "estimates," "expects," "projects," "plans," "anticipates" and variations thereof, or the use of future tense, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Forward-looking statements specifically include statements about leronlimab, its ability to have positive health outcomes, the possible results of clinical trials, studies or other programs or ability to continue those programs, the ability to obtain regulatory approval for commercial sales, and the market for actual commercial sales. The Company's forward-looking statements are not guarantees of performance, and actual results could vary materially from those contained in or expressed by such statements due to risks and uncertainties including: (i) the sufficiency of the Company's cash position, (ii) the Company's ability to raise additional capital to fund its operations, (iii) the Company's ability to meet its debt obligations, if any, (iv) the Company's ability to enter into partnership or licensing arrangements with third parties, (v) the Company's ability to identify patients to enroll in its clinical trials in a timely fashion, (vi) the Company's ability to achieve approval of a marketable product, (vii) the design, implementation and conduct of the Company's clinical trials, (viii) the results of the Company's clinical trials, including the possibility of unfavorable clinical trial results, (ix) the market for, and marketability of, any product that is approved, (x) the existence or development of vaccines, drugs, or other treatments that are viewed by medical professionals or patients as superior to the Company's products, (xi) regulatory initiatives, compliance with governmental regulations and the regulatory approval process, (xii) general economic and business conditions, (xiii) changes in foreign, political, and social conditions, and (xiv) various other matters, many of which are beyond the Company's control. The Company urges investors to consider specifically the various risk factors identified in its most recent Form 10-K, and any risk factors or cautionary statements included in any subsequent Form 10-Q or Form 8-K, filed with the Securities and Exchange Commission. Except as required by law, the Company does not undertake any responsibility to update any forward-looking statements to take into account events or circumstances that occur after the date of this press release.

CONTACTSInvestors: Michael MulhollandOffice: 360.980.8524, ext. 102mmulholland@cytodyn.com

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CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help...

Bone Marrow Stem Cells Comments Off on CytoDyn Completes Second Non-dilutive $28.5 Million Convertible Note Financing with Conversion Rate at $10.00 Per Share Without Warrants to Help… | November 12th, 2020

WINNIPEG -- A baby boy in Winnipeg is in need of a bone marrow transplant to survive, but he has yet to find a donor.

Three-month-old Boston has a rare disease called hemophagocytic lymphohistiocytosis HLH, a rare auto-inflammatory condition with his immune system.

His mother Simone Jannetta, who is a nurse at Grace Hospital, said they need someone who is of mixed race to donate stem cells.

Thats the only way to cure this, she said.

In the meantime, hes just receiving chemotherapy and steroids to help keep him well until then."

Jannetta said the reason they are having difficulty finding a match is because they need someone half Filipino and half Caucasian, and there are not many mixed-race donors currently in the Canadian and worldwide stem cell registries.

A TOUGH ROAD FOR FAMILY DEALING WITH HEALTH ISSUES

This is not the first time the family has dealt with a child facing health issues over the last few years.

When Jannettas daughter and Bostons older sister Beatrix was seven-months-old she presented to the emergency department with a fever and low blood counts. After a bone marrow biopsy, they learned she had a rare condition called autoimmune neutropenia.

So her immune system is not well either, shes very susceptible to infection too, Jannetta said.

Weve had a lot of back and forth with the hospital through herits been a tough road for us.

Anyone in Canada who wants to register to see if they are a match for Boston can go to the Canadian Blood Services website and look up the stem cell registry.

Boston also has his own link where you can register. The Canadian Blood Services will then mail you a kit with a swab, which you can send back once completed.

Its that simple, Jannetta said.

Youre put on the registry and Boston can then match with somebody.

For anyone who is thinking about registering to become a stem cell donor, Jannetta wants them to know they could save somebodys life.

Its not hard, theres no obligation follow through even if you do register, she said.

Theres just such a small representation of ethnically-diverse people on the registry and I just feel like everybody deserves a chance.

- With files from CTVs Nicole Dube.

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Three-month-old Winnipeg boy in need of bone marrow transplant to survive - CTV News Winnipeg

Bone Marrow Stem Cells Comments Off on Three-month-old Winnipeg boy in need of bone marrow transplant to survive – CTV News Winnipeg | November 10th, 2020

Troy McKinley donated stem cells to help a stranger with blood cancer.

Think about your birthday wish this year? Did it involve saving someone's life?

A Reynoldsburg man's wish did.

Thirty-five-year-olf Troy McKinely wanted to make sure his birthday wish made a difference in someone else's life.

I wanted to do something big if possible. I've never donated blood before I don't even like needles, he said.

Two years ago, he decided he wanted to make his birthday more about gifts, and instead give the gift of life.

I thought it would be great to save a life so what can I do to help, he said

He found DKMS, the world's largest bone marrow and blood stem cell donor center.

The company sent him a swab kit and he waited to see if he would be a match. Two and a half years later, he was notified that his stem cells matched a patient who was diagnosed with blood cancer.

It was kind of like 'wow this is big. I don't know this person. I don't know anything about him or her.' It's kind of amazing feeling that it could be better for somebody else, he said.

McKinley said it only took a few hours to give the needed stem cells that doctors would later implant to the unknown patient.

I'm hoping that this gentleman I helped is feeling better for it and helped him in some way. Maybe it didn't give him everything back but he has some more time and we all want more time in the world so hopefully, it helped him, he said.

Time, we can all use more of it, but how many of us take the time to think about how we can give others more days on this earth.

It was a birthday wish McKinley says he'd do again knowing his kindness gave a stranger something more valuable than anything.

I think it's amazing to save someone's life. It's an incredible experience, he said.

About DKMS

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Reynoldsburg man makes unusual birthday wish: 'I wanted to save someone's life' - 10TV

Bone Marrow Stem Cells Comments Off on Reynoldsburg man makes unusual birthday wish: ‘I wanted to save someone’s life’ – 10TV | November 10th, 2020

A new study led by the University of Edinburgh and Queen Mary University of London has identified a protein that plays a crucial role in protecting the bodys blood stem cells from damage during infection, a finding that could lead to new ways to slow down the aging process.

Hematopoietic stem cells (HSCs) are found in bone marrow, and from there they produce other blood and immune cells. When an infection strikes the body, HSCs are known to ramp up production to fight it off but thats raised some questions for scientists in the past. In particular, how do they protect themselves from damage while working overtime?

We know that inflammatory pathways induced by infection force blood stem cells to rapidly produce immune cells to help combat infections, says Kamil Kranc, corresponding author of the study. However, these pathways can eventually exhaust stem cells or cause their premature aging, and it is important to understand how this can be stopped.

In the new study, the researchers identified a protein called YTHDF2 that seems to be responsible for this important job. When an infection arises, the HSCs produce far more immune cells, but at the same time that triggers inflammatory processes that can damage the stem cells. The study found that the YTHDF2 protein regulates genes that control those inflammatory processes, protecting the stem cells from premature aging.

To investigate the role of YTHDF2, the team engineered mice to be deficient in the protein, then administered a chemical that acts like a viral infection. Sure enough, the mices HSCs appeared to suffer chronic inflammation, altering the production of different blood cell types. Interestingly, the blood of these young animals began to resemble that of much older mice.

The new study seems to agree with previous reports that blood transfusions from young animals to older ones can improve the health of the recipient, and even slow the progression of diseases like Alzheimer's. As such, the team says that future work could investigate whether manipulating levels of YTHDF2 may be a potential anti-aging treatment.

The research was published in the Journal of Experimental Medicine.

Source: University of Edinburgh

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Protective protein could help keep blood young and healthy - New Atlas

Bone Marrow Stem Cells Comments Off on Protective protein could help keep blood young and healthy – New Atlas | November 10th, 2020

Some people live by the adage, if it aint broke, dont fix it. When Dr. Adewunmi (Ade) Nuga looks at the world she asks a different question: could we make this even better?

Dr. Nuga is now a primary care physician at Pacific Medical Centers (PacMed) Canyon Park, but before she went to medical school she earned a PhD in Microbiology and conducted medical research.

One of my research areas was retroviruses, which is the class of virus that HIV belongs to. I wanted to understand why patients with HIV cant stop taking the medications to treat it, even when theyve taken those medications for decades. Where is the virus hiding in the body?

Advances in medications mean patients with HIV can now expect to live an average lifespan, but that wasnt good enough for Dr. Nuga. She hopes her research into bone marrow stem cells will contribute to a cure.

Only two people in the world are confirmed to have been cured of HIV, and both of them received a stem cell transplant as part of their treatment, she says.

Coordinating your care

HIV treatment is not yet part of Dr. Nugas practice, but as a primary care physician she coordinates with specialists and ensures her patients receive comprehensive care for the best possible outcomes. Since people living with HIV can expect to live an average lifespan, they need to continue caring for other aspects of their health in addition to HIV care cancer screenings, mental health, and other ongoing primary care.

Think of Dr. Nuga as your health care quarterback: calling plays and adapting strategies on the fly to develop a treatment plan that works for you. That may mean adjusting doses to your weight and age, but it could also mean adjusting referrals to accommodate your culture, social class or even access to transportation.

I want to address the barriers to care and deliver healthcare to everyone that needs it, regardless of their status. The resources at PacMed are a big help I can coordinate with care managers and community health liaisons to make sure nobody falls through the cracks, she says.

Dr. Nuga loves taking care of patients of all ages, life stages and social situations, and she has a soft spot for children.

Theres a special privilege that comes with taking care of babies from the first day of life, she says, and she hopes to have more opportunities to practice pediatrics.

Another way Dr. Nuga hopes to improve healthcare? Wit better representation throughout the system so patients see themselves in health care professionals from patient care to management.

Im hoping to get involved with the Providence mentorship program, to help inspire the next generation. The number of physicians from some minority groups hasnt changed since 1978 its kind of astounding that over 40 years we havent been able to increase representation, she says. If we improve access to care we make the environment better for everyone.

Dr. Nugas pediatric and internal medicine practice is open to people of all ages, from newborns to geriatrics. Make an appointment with Dr. Nuga for you or your child by calling 425-412-7200 or booking online. Find Dr. Nuga at Pacific Medical Centers (PacMed) Canyon Park, 1909 214th St. SE, in Bothell.

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Her favorite part of research was the patients, so she switched to primary... - Bothell-Kenmore Reporter

Bone Marrow Stem Cells Comments Off on Her favorite part of research was the patients, so she switched to primary… – Bothell-Kenmore Reporter | November 10th, 2020

Cell harvesting usuallyfor use incanceror other treatment. Usually the cells are removed from the patients own bone marrow. Stem cells can be harvested from the blood or bone marrow. Umbilical cords have been saved as a future source of stem cells for the baby..cagr1 with growth trends, various stakeholders like investors, CEOs, traders, suppliers, Research & media, Global Manager, Director, President, SWOT analysis i.e. Strength, Weakness, Opportunities and Threat to the organization and others.

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Bone Marrow Stem Cells Comments Off on Cell Harvesting Market 2020 Growth Analysis, Share, and consumption by Regional data, Investigation and Growth, Demand by Regions, Types and Analysis… | November 10th, 2020