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Category Archives: Stem Cell Therapy

Diabetic foot treatment: Here’s all you need to know about stem cell therapy – Hindustan Times

Posted: July 11, 2022 at 2:05 am

Diabetes is nothing less than a pandemic as according to the World Health Organization, about 422 million people have diabetes worldwide. High blood sugar levels affect different organs and tissues of the body leading to a compromised quality of life for example, you might have experienced or heard of tingling sensation, numbness, or pain in the legs/feet of patients with diabetes which as per the health experts, occur due to nerve and blood circulation-related problems caused by the negative effects of high glucose levels on cells and tissues.

Foot-related problems occur commonly in patients with diabetes like if we hurt our toe/foot and have an open wound or cut, the nerve endings from the affected part send signals to the brain and cause pain. In case a person with uncontrolled and long-standing diabetes, the sensation of pain may not be transmitted properly due to nerve issues, leading to the patient ignoring the problem and in such cases, even a small cut can progress to a large size wound (as we know wound healing is affected in diabetic patients).

Infection can spread from the feet through the blood to other parts of the body as well and in the feet specifically, increased severity of the issue can lead to gangrene, ultimately necessitating amputation of the toes/foot. It is therefore important to look out for issues such as cuts, bruises, red spots, warm areas, swelling, blisters, corn, etc. in the feet to identify any issue at the earliest and initiate treatment.

From an advanced treatment perspective, Dr Pradeep Mahajan, Regenerative Medicine Researcher at Navi Mumbai's StemRx Bioscience Solutions Pvt Ltd, talked about regenerative medicine for diabetic foot in an interview with HT Lifestyle. He explained, Regenerative medicine is about using biological molecules to enhance the healing potential of the body. These molecules are cells, growth factors, exosomes, peptides, all of which function to enhance the function of other cells in the body, reduce inflammation, regulate the immune system, provide a constant pool of healthy cells, and clear tissue damage, among other functions.

He highlighted that the treatment for diabetic foot includes a combination of mesenchymal stem cells, growth factors that improve nerve health and blood vessel formation, oxygen therapy, as well as allied stimulation-based treatments. He said, We have seen successful outcomes in diabetic foot conditions following cell-based therapy. Patients experience relief from abnormal sensations in the feet, better wound healing and pain along with better control of diabetes.

Dr Mahajan added, When we target the pathology, we get more definitive treatment outcomes. Our patients with diabetic foot do not progress to develop gangrene. In fact, they even achieve better control of blood glucose levels, which prevents further complication and improves their quality of life. The key is a regenerative (not symptomatic) treatment along with lifestyle modifications.

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Global Stem Cell Manufacturing Market Value Projected To Reach USD 21.71 Billion By 2029, Registering A CAGR Of 9.1% – Digital Journal

Posted: July 11, 2022 at 2:05 am

Global Stem Cell ManufacturingMarket Is Expected To Reach USD 21.71 Billion By 2029 At A CAGR Of 9.1 percent.

Maximize Market Research has published a report on theGlobal Stem Cell Manufacturing Marketthat provides a detailed analysis for the forecast period of 2022 to 2029.

Global Stem Cell ManufacturingMarket Scope:

The report provides comprehensive market insights for industry stakeholders, including an explanation of complicated market data in simple language, the industrys history and present situation, as well as expected market size and trends. The research investigates all industry categories, with an emphasis on key companies such as market leaders, followers, and new entrants. The paper includes a full PESTLE analysis for each country. A thorough picture of the competitive landscape of major competitors in theGlobal Stem Cell Manufacturingmarket by goods and services, revenue, financial situation, portfolio, growth plans, and geographical presence makes the study an investors guide.

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Global Stem Cell Manufacturing Market Overview:

Observing stem cells evolve into cells in bones, the circulatory system, nerve cells, and other organs of the body may help scientists understand how illnesses and disorders occur. Stem cells can be programmed to generate particular cells that can be utilized in humans to grow and mend tissues that have been damaged or harmed by sickness. Stem cell therapy may assist people with spinal cord injuries, metabolic disorders, Parkinsons disease, amyotrophic lateral sclerosis, Alzheimers disease, cardiovascular disorders, brain hemorrhage, burns, malignancy, and rheumatoid arthritis. Stem cells can be used to create new tissue for transplant and genetic engineering. Doctors are always learning more about stem cells and how they might be used in transplant and cellular therapies.

Global Stem Cell ManufacturingMarketDynamics:

Stem cells are crucial in illness treatment and specialized research initiatives such as customized therapy and genetic testing. As public and commercial stakeholders throughout the world become more aware of stem cells therapeutic potential and the scarcity of therapeutic approaches for rare illnesses, they are increasingly focusing on the development of stem cell-based technology.

Specialized procedures are required for stem cell separation, refinement, and storage (such as expansion, differentiation, cell culture media preparation, and cryopreservation). Additionally, the production scale-up of stem cell lines and associated items is frequently accompanied by major technological challenges that impede the whole production process and result in large operational expenses. As a result, stem cell products are frequently more expensive than pharmaceutical medications and biopharmaceuticals.

Additionally, the growing popularity of tailored medications is driving the market growth. Scientists are researching novel procurement strategies that can be used to manufacture tailored medications. For example, iPSC treatments are created by taking a little amount of a patients plasma or skin cells and reprogramming them to make new cells and tissue for transplant. As a result, future tailored treatments can be produced using these cells.

Global Stem Cell ManufacturingMarketRegional Insights:

North America (particularly the United States) held the largest market share in 2021, owing to factors such as the availability of significant contenders active in creating stem cell treatments, enhanced medical facilities, significant R&D financial backing available, and favorable initiatives from healthcare organizations, as well as robust reimbursement. Because of government initiatives and serious scientific activity in the country, the United States leads the continentsGlobal Stem Cell Manufacturingmarket.

Healthcare organizations are promoting cellular therapies for rising ailments. Due to higher advancement of stem cell-based treatments, federal actions for creating regenerative medications, the creation of multiple stem cell banks, and the continents increasing clinical studies for genetic manipulation and medical technology, the APACGlobal Stem Cell Manufacturingmarket is expected to grow at the fastest rate during the forecast period.

Global Stem Cell ManufacturingMarketSegmentation:

By Product:

By Application:

By Technology:

By Therapy:

Global Stem Cell ManufacturingMarket Key Competitors:

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Global Stem Cell Manufacturing Market Value Projected To Reach USD 21.71 Billion By 2029, Registering A CAGR Of 9.1% - Digital Journal

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Every 5 minutes someone in India is diagnosed with blood cancer or a blood disorder: Patrick Paul, CEO, DKMS BMST Foundation India – The Financial…

Posted: July 11, 2022 at 2:05 am

India has a high prevalence of blood cancer and other blood-related disorders like Thalassemia or Aplastic Anemia. Despite a large number of cases, patients suffering from such conditions are forced to struggle with their treatments and therapies. DKMS BMST Foundation India, a non-profit Organisation, is dedicated to the fight against blood cancer and other blood disorders, such as thalassemia and aplastic anemia. It is a joint venture of two reputed Non-profit Organisations: BMST (Bangalore Medical Services Trust) and DKMS, one of the largest international blood stem cell donor centres in the world. Financial Express.com reached out to Patrick Paul, CEO, DKMS BMST Foundation India and he highlighted the status of blood disorders in India, challenges faced by the patients suffering from these diseases and role of DKMS BMST Foundation India in patient care in the country among others. Excerpts:

What are the various types of blood cancers that are prevalent in India?

Blood Cancer typically means malignancies of the blood, bone marrow or lymph nodes that affect normal blood cell production or function.

Of all types of Blood Cancers, here are the three most common types of blood cancer that affects the Indian population mentioned in order of the rate of incidence.

Lymphoma is the name for a group of blood cancers that develop in the lymphatic system. The two main types are Hodgkin lymphoma (generally starts in blood and bone marrow) and non-Hodgkin lymphoma (generally starts in lymph node and lymphatic tissue.)

Leukemia is a blood cancer that develops when normal blood cells change and grow uncontrollably. There are four main types named according to the cells affected (myeloblasts, lymphocytes) and whether the disease starts with mature or immature cells (chronic, acute).

Multiple myeloma starts in the bone marrow when plasma cells begin to grow uncontrollably. As the cells grow, they compromise the immune system and impair the production and function of white and red blood cells causing bone disease, organ damage and anemia among other conditions.

What are the challenges that a blood cancer patient faces in India? What needs to be done to help them in overcoming those hurdles?

Every 5 minutes someone in India is diagnosed with blood cancer or a blood disorder such as Thalassemia or Aplastic Anemia. Despite this huge cancer burden, In India, only 0.04% of the total population is registered as a potential blood stem cell donor. While blood cancer is life-threatening, a set of healthy blood stem cells from a matching donor can be life-saving. The demand and supply gap are increasing as people dont register themselves as potential blood stem cell donors due to lack of awareness.

Only about 30% of the patients in need of a stem cell transplant as lifesaving treatment can find a sibling match. The rest 70% depend on finding a matching unrelated donor which makes it vital for people to register themselves as potential donors and help save a life.

How does DKMS BMST Foundation India help patients with blood cancer? In recent years, what are the crucial milestones that the organization has achieved in the country?

DKMS-BMST helps blood cancer patients by:

Raising awareness and educating the general public about the importance of blood stem cell donation

Recruiting donors by encouraging people of diverse ethnicities to register as a potential blood stem cell donor. Recruitment is done through various registration drives at different colleges, corporates, and associations and through online portal.

Matching and collection of stem cells by facilitating search requests in collaboration with transplant centers, collection, processing and transport of stem cell product

Ensuring donor safety and following up post the procedure to monitor the well-being of the donors

Supporting patients and families with information and organization of registration events

Research to advance blood cancer treatment and improve the success rate of transplants

DKMS-BMST has organized over 1300 donor registration drives with focus on South India in the last one year across various organizations such as corporates, educational institutes, hospitals and defense forces to spread awareness about blood stem cell donation and enroll more potential donors. So far, DKMS-BMST have successfully registered over 70,000 potential blood stem cell donors.

While our donor recruitment team is responsible to register potential donors, our medical team works with transplant centers and collection centers. As soon as we receive a direct request from a transplant center for a patient from India or abroad, a worldwide search is started to determine whether there is a donor available. If there is a donor from DKMS-BMST, we contact this donor and initiate all the steps for a successful blood stem cell donation. So far, we have arranged 29 successful donations and were thus able to offer 29 patients a second chance at life.

Other than blood cancers, what are the other focal areas of DKMS BMST Foundation India?

DKMS BMST Foundation India is a non-profit organization dedicated to the fight against blood cancer and other blood disorders, such as thalassemia and aplastic anemia.

Our aim is to improve the situation of patients suffering from blood cancer and other blood disorders in India, by raising awareness about blood stem cell transplantation and registering potential blood stem cell donors. By doing this, DKMS-BMST provides patients in need of a blood stem cell transplant with a second chance at life.

How the ongoing COVID-19 pandemic has affected the treatment and diagnosis of hemoglobinopathy and other blood disorders?

Blood cancer and other blood disorder patients suffer from immune deficiency. Even regular respiratory viruses are a problem and the spread of coronavirus is a major risk for the patients. These patients are more sensitive to infection than any other group, because the treatment itself destroys their own immune system, and replaces it with the donors. Thus, the management of such high-risk patients have also become challenging in this situation. The Covid-19 pandemic had posed lot of challenges for patients with hematological-oncological conditions and in need of a blood stem cell transplant. In the context of unrelated blood stem cell transplants there is lots of logistic support needed. The lockdown situations used to impact the usual process for transporting blood stem cells across borders and countries. There was also a fear factor in the voluntary blood stem cell donors about blood stem cell donation during this time.

However, now the situation is getting better and we are registering potential donors through online and offline activities as well.

What are the common misconceptions that you come across related to blood cancers and other blood-related disorders in India?

A lack of understanding and multiple baseless misconceptions existing amongst people about the process, impacts the cause. People often mistake a blood stem cell transplant as a painful procedure. The blood stem cell donors need not undergo any surgical procedure as the stem cells are collected from the donors blood. The process followed is similar to donating blood platelets. It is high time that we all overcome these misconceptions and commit to being a lifesaver.

What are the challenges DKMS BMST Foundation India faces while recruiting Indian donors? What is the importance of recruiting young donors?

As the number of patients increase every year, the number of transplants increase proportionately. But the problem is, due to the lack of awareness and general misconception about stem cell transplants in India, there are only 0.04% of the population that are registered as potential blood stem cell donors. This makes it very difficult for a patient to be able to find an HLA (Human Leucocyte Antigen) matched donor. While misinformation and/or lack of information is the biggest challenge faced by all potential blood stem cell donors today, multiple myths associated with a stem cell donation pose a greater threat.

Some of the common myths include:

Myth: Donating blood stem cells means losing them forever.

Fact: When you donate your stem cells, you are only donating a fraction of your total stem cells.

All the cells will naturally be replenished within a few weeks

Myth: Donating stem cells is an invasive and painful process

Fact: Blood stem cells are collected through peripheral blood stem cell collection (PBSC) which is completely safe and a non-surgical procedure. The process is similar to blood platelet donation that takes approximately three to four hours to complete and the donor can leave the collection center the same day.

Myth: Blood Donation and a blood stem cell donation are same

Fact: Unlike blood collection for transfusion, blood stem cells are collected only when there is a match between the donor and patients Human leukocyte antigen (HLA) (tissue type).

So, you could be potentially be the only match and lifesaver for a person with blood cancer in need of a transplant. Blood stem cell donors donate only blood stem cells and the process is similar to a platelet donation.

Myth: Joining a blood stem cell registry is of no use. Most patients can find a stem cell donor within their own families.

Fact: Per statistics, only 30% of blood disorder patients in need of a stem cell transplant are able to find a sibling match. About 70 percent of patients need an unrelated donor.

What is the significance of Stem Cell Transplant as a treatment option?

Due to the advanced medical technologies and increased research, life-threatening diseases such as blood cancer can be treated through stem cell transplants. Stem cell transplantation is a procedure that restores blood-forming stem cells in people who have had theirs destroyed by the very high doses of chemotherapy or radiation therapy. Healthy blood stem cells from a matching donor is infused into the patient to help resume healthy blood production.

What are future plans for DKMS-BMST in India? In the coming years, what will be the status of India with respect to stem-cell therapies?

DKMS-BMST will continue working with its mission to help blood cancer and blood disorder patients by raising awareness, organizing donor registration events to recruit more potential blood stem cell donors of Indian origin, thus increasing the chances of finding matching donors for patient in need of a lifesaving stem cell transplant and facilitating successful blood stem cell donations. Since, ethnicity plays a crucial role in finding a matching donor, the ratio of potential blood stem cell donors from India needs to rise significantly.

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Every 5 minutes someone in India is diagnosed with blood cancer or a blood disorder: Patrick Paul, CEO, DKMS BMST Foundation India - The Financial...

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Growing Prevalence & Recurrence Of Rheumatoid Arthritis Is Expected To Growth Of The Rheumatoid Arthritis Stem Cell Therapy Market Designer Women…

Posted: July 11, 2022 at 2:05 am

The Global Rheumatoid Arthritis Stem Cell Therapy Market is replete with new growth opportunities and expansion avenues. There has been an increase in the use of products and services falling under the ambit of Rheumatoid Arthritis Stem Cell Therapy, giving a thrust to the growth of the global Rheumatoid Arthritis Stem Cell Therapy market. The unprecedented use of these products can be attributed to the increasing paying capacity of the masses.

Furthermore, in the absence of robust or utilitarian alternatives, the demand within the global Rheumatoid Arthritis Stem Cell Therapy market is projected to reach new heights of recognition. It is worthwhile to mention that the global Rheumatoid Arthritis Stem Cell Therapy market is treading along a lucrative pathway due to favorable government legislations.

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The COVID-19 pandemic has changed narratives related to growth and expansion across several key industries. Therefore, the Rheumatoid Arthritis Stem Cell Therapy market is also battling the cons of supply chain disruptions and procurement issues. Over the course of the next quarter, market players could be investing in new technologies to recover from the shocks of the pandemic.

The global market for rheumatoid arthritis stem cell therapy is highly fragmented. Examples of some of the key players operating in the global rheumatoid arthritis stem cell therapy market include Mesoblast Ltd., Roslin Cells, Regeneus Ltd, ReNeuron Group plc, International Stem Cell Corporation, TiGenix and others.

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Tentatively, the global rheumatoid arthritis stem cell therapy market can be segmented on the basis of treatment type, application, end-user, and geography.

Based on treatment type, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on application, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on the distribution channel, the global rheumatoid arthritis stem cell therapy market can be segmented into:

Based on geography, the global rheumatoid arthritis stem cell therapy market can be segmented into:

The study further identifies major manufacturing trends, technologies that will be commercialized

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Growing Prevalence & Recurrence Of Rheumatoid Arthritis Is Expected To Growth Of The Rheumatoid Arthritis Stem Cell Therapy Market Designer Women...

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New sickle cell disease gene therapies depend on getting the right mouse – EurekAlert

Posted: July 11, 2022 at 2:05 am

image:Human red blood cells with sickle cell disease view more

Credit: Image courtesy of the Weiss lab. For permission to reuse, please contact St. Jude Childrens Research Hospital.

Sickle cell disease is an extremely debilitating condition that affects up to 40% of the population in African countries, with patients suffering episodes of excruciating pain, organ damage and reduced life-expectancy. This disease is caused by a mutation in a gene that makes haemoglobin, the protein that carries oxygen in red blood cells, with the damaged haemoglobin distorting the shape of red blood cells, causing painful and potentially life-threatening blockages in blood vessels. However, scientists have realised that increasing the production of a healthy form of this protein (foetal haemoglobin, which is usually only produced when we are in the womb), could provide a revolutionary treatment for these patients. In their current Disease Models & Mechanisms article, Mitchell Weiss and colleagues from St. Jude Childrens Research Hospital, Memphis, USA, investigated a promising new treatment that is being developed in Weiss lab and works by editing genes to switch on the production of this healthy, foetal haemoglobin in adult red blood cells. When testing the treatment in mice, the researchers found that even though the lab mice had the symptoms of sickle cell disease, the foetal haemoglobin gene and surrounding DNA were not properly configured, making the revolutionary stem-cell treatment ineffective or even harmful in the animals and raising concerns for future research testing new gene-based therapies in these laboratory mice.

Before a new treatment can be tested on people, scientists test them on laboratory animals, so Weiss and colleagues tried their new gene therapy in two types of mice that carry the symptoms of sickle cell disease: so-called Berkeley and Townes mice. First, they removed stem cells cells in the bone marrow programmed to become red blood cells from the mice and used gene editing to modify part of the stem cells DNA to switch on the healthy foetal haemoglobin gene. The scientists then put these reprogrammed stem cells back into the mice and monitored the animals for 18 weeks to find out how the treatment affected them.

Surprisingly, 70% of the Berkeley mice died from the therapy and it only activated production of the healing foetal haemoglobin gene in 3.1% of mouses stem cells. In contrast, the experimental treatment activated the foetal haemoglobin gene in 57% of red blood cells in the Townes mice and did not affect the animals survival. However, the levels of foetal haemoglobin produced in the red blood cells of Townes mice were 7- to 10-times lower than seen when this approach is used in human cells grown in the laboratory and not high enough to reduce clinical signs of sickle cell disease.

Weiss and colleagues then wanted to find out why this new treatment was not successful in the Berkeley mice, which have been used for decades to test treatments for sickle cell disease. Dr Weiss says, We realized that we did not know enough about the genetic configurations of these mice. Therefore, the team sequenced the haemoglobin genes and surrounding DNA of the Berkeley mice and discovered that instead of having a single copy of the mutated human gene, the mice had 22 randomly arranged, broken-up copies of the mutated human sickle cell disease gene and 27 copies of the human foetal haemoglobin that the team had hoped to activate to cure the mice of the disease. This complex genetic make-up caused the fatal effects when the scientists tested the gene therapy in the Berkeley mice, as editing multiple copies of a gene can damage the DNA. This means that researchers cannot use these mice to test and optimise this gene-editing treatment.

In contrast, the Townes mice only had single copies of the mutated human haemoglobin gene and the gene that makes human foetal haemoglobin. However, these mice likely lacked crucial pieces of DNA that normally regulate the production of the foetal haemoglobin gene in humans. Therefore, they couldnt produce enough of this healthy protein to alleviate the mouse symptoms. Dr Weiss commented, Our findings will help scientists using the Berkeley and Townes mice decide which to use to address their specific research question relating to sickle cell disease or haemoglobin. Additionally, this work provides a reminder for scientists to carefully consider the genetics of the mice that they are using to study human diseases and find the right mouse for the job.

Disease Models & Mechanisms

Experimental study

Animals

Limitations of mouse models for sickle cell disease conferred by their human globin transgene configurations

6-Jul-2022

Dr Weiss is on advisory boards for Cellarity Inc., Novartis, Graphite Bio and Forma Therapeutics.The other authors declare no competing financial interests. Co-author Akshay Sharma is the site principal investigator of clinical trials for genome editing of sickle cell disease sponsored by Vertex Pharmaceuticals/CRISPR Therapeutics(NCT03745287)and Novartis(NCT04443907). The industry sponsors provide funding for the clinical trial, which includes salary support. Akshay Sharma hasreceived consultant fee from Spotlight Therapeutics, Medexus Inc. and Vertex Pharmaceuticals. He has also received research funding from CRISPR Therapeutics and honoraria from Vindico Medical Education.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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Market Share, Supply, Analysis and Forecast of Human Insulin Drugs and Delivery Devices to 2026 Designer Women – Designer Women

Posted: July 3, 2022 at 2:41 am

The GlobalHuman Insulin Delivery Drugs and DevicesMarket will grow from its initial estimated value of USD 33.78 billion in 2018 to an estimated value of USD 61.38 billion by 2026, registering a CAGR of 7.75 % over the forecast period 2019-2026.This increase in market value can be attributed to the increasing incidence of diabetes and diabetic patients around the world.The increased incidence of diabetes may be linked to the unhealthy lifestyle and diet of the larger percentage of the population.

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Segmentation: Global Human Insulin Drugs and Delivery Devices Market

For more insights into Market Analysis, view Research Report Summary athttps://www.databridgemarketresearch.com/reports/global-human-insulin-drugs-and-delivery-devices-market

Competitive Analysis: Global Human Insulin Drugs and Delivery Devices Market

The global human insulin delivery devices and drugs 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 presence in this market.The report includes Human Insulin Delivery Devices and Drugs market shares for Global, Europe, North America, Asia-Pacific, South America, Middle- East and Africa.

Key Market Competitors: Global Human Insulin Drugs and Devices Market

Some of the major competitors currently operating in the human insulin drugs and delivery devices market include Novo Nordisk A/S, Eli Lilly and Company, Sanofi, B. Braun Melsungen AG, BD, Biocon, Albireo Pharma Inc., Julphar, WOCKHARDT, CeQur SA, Ypsomed, AstraZeneca, Boehringer Ingelheim International GmbH, Johnson & Johnson Services Inc., Novartis AG, Takeda Pharmaceutical Company Limited, Bayer AG and Merck & Co. Inc.

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Global Allogeneic Stem Cell Therapy Market: Industry Trends and Forecast to 2027

https://www.databridgemarketresearch.com/reports/global-allogenic-stem-cell-therapy-market

Global Cancer Stem Cell Therapy Market: Industry Trends and Forecast to 2028

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Market Share, Supply, Analysis and Forecast of Human Insulin Drugs and Delivery Devices to 2026 Designer Women - Designer Women

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Gamida Cell Submits Biologics License Application for Omidubicel to the FDA – Pharmacy Times

Posted: June 22, 2022 at 2:43 am

The drug is being evaluated as the first potential allogeneic advanced cell therapy donor source for patients with blood cancers in need of a transplant.

Gamida Cell has completed the rolling biologics license application (BLA) submission to the FDA for omidubicel for the treatment of individuals with blood cancer who need an allogenic hematopoietic stem cell transplant, the company said in a statement.1

Omidubicel is an advanced cell therapy candidate that was developed as an allogeneic hematopoietic stem cell transplant for individuals with blood cancer. It is the first stem cell transplant donor source to receive breakthrough therapy designation from the FDA.1

Additionally, it has received orphan drug designation in the European Union and the United States.1

The BLA submission marks an important milestone for both Gamida and the transplant community, as omidubicel has the potential to be the first approved advanced cell therapy product for allogeneic stem cell transplantation, Julian Adams, PhD, CEO of Gamida Cell, said in the statement.1

Completion of this BLA submission is a key inflection point in our mission to deliver a new treatment option for patients with blood cancers. We look forward to working closely with the FDA to bring this potentially important therapy to patients, Adams said.1

The FDA has 60 days to determine whether the BLA for omidubicel is acceptable for filing.1

The BLA is supported by the results of a phase 3 study published in Blood, the journal of the American Society of Hematology. The study met its primary endpoint of the median time to neutrophil engraftment in individuals with hematologic malignancies undergoing allogeneic bone marrow transplant, with patients receiving omidubicel having a median time of 12 days compared with 22 days for the umbilical cord blood graft group.1

In the key secondary endpoints of the study, approximately 55% of individuals receiving omidubicel achieved platelet engraftment by day 42 compared with approximately 35% for the comparator.1

Additionally, the rate of infection was significantly reduced, with the cumulative incidence of first grade 2 or grade 3 bacterial or invasive fungal infection for individuals randomized to omidubicel being 37% compared with 57% for the comparator.1

Hospitalization in the first 100 days after transplant was significantly reduced with a median number of days alive and out of hospital for individuals randomized to omidubicel was 61 days compared with 48 days for the comparator.1

Furthermore, 1-year post-transplant data showed sustained clinical benefits with omidubicel as demonstrated by a significant reduction in infectious complications and reduced non-relapse mortality. There was no significant increase in increases in graft-versus-host-disease rates or the relapse rate.1

The results showed that transplantation after an individual received omidubicel had fewer bacterial and viral infections and less time in the hospital, investigators said.2

Omidubicel was generally well tolerated in the phase 3 study.1

Investigators reported that the incidence of treatment-emergent serious adverse events were similar in both arms, with approximately 40% in the omidubicel group and 41% for the comparator.2

References

1. Omidubicel has orphan drug designation and breakthrough therapy designation. Gamida Cell. News release. June 2, 2022. Accessed June 3, 2022. https://investors.gamida-cell.com/news-events/press-releases/news-release-details/gamida-cell-completes-rolling-biologics-license

2. Horwitz ME, Stiff PJ, Cutler C, Brunstein C, et al; Omidubicel vs standard myeloablative umbilical cord blood transplantation: results of a phase 3 randomized study. Blood. 2021;138(16):1429-1440. doi: 10.1182/blood.2021011719

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Global Rheumatoid Arthritis Stem Cell Therapy Market 2022 Swot Analysis by Top Key Vendors, Demand And Forecast Research to 2028 Designer Women -…

Posted: June 22, 2022 at 2:43 am

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Global Rheumatoid Arthritis Stem Cell Therapy Market 2022 Swot Analysis by Top Key Vendors, Demand And Forecast Research to 2028 Designer Women -...

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Stem Cell Therapy in Jacksonville at Pangenics Regenerative Center

Posted: June 13, 2022 at 2:31 am

When considering stem cell therapy, it is important to understand, that our bodies produce different types of stem cells, and that different stem cells replicate and differentiate to repair and replace damaged and dead cells in different areas of our body. It is also important to understand that there are different ways of harvesting or gathering stem cells, some more effective than others. And quantity matters.

At Pangenics, our physicians use a closed and sterile 38 step process to collect a patients own live fat derived mesenchymal adult stem cells. This process allows for the collection and preparation of up to 50 million verified live stem cells from only 2 ounces of body fat. These mesenchymal stem cells are multipotent stem cells that have the ability to self renew, (replicate) and differentiate into a variety of cell types including bone cells, cartilage cells, muscle cells and fat cells. As a result, they are the correct type of stem cells to serve as a therapy for joint and spine conditions and injuries, and certain plastic surgery procedures that involve fat transfers.

The chart below is from a patients stem cell therapy records which is placed on their charts. We use a NucleoCounter, (laboratory grade) Cell Counter in every stem cell therapy case to record the number of live mesenchymal stem cells harvested and used in their therapy. During this patients therapy, we successfully harvested over 17 million of the patients own live mesenchymal stem cells and immediately used them for their therapy. Our doctors injected a large number of stem cells into the treatment areas and administered the remaining stem cells via IV.

While stem cell therapy cannot help all conditions and injuries, it has helped the majority of our patients suffering with joint and back pain and in certain plastic surgery procedures that involve fat transfer. Contact us to schedule a courtesy consultation or for more information about stem cell therapy in Jacksonville, Florida at Pangenics Regenerative Center.

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Stem Cell Therapy in Jacksonville at Pangenics Regenerative Center

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Stem-Cell Based Therapy Shows Promise in Treating High-Risk Type 1 Diabetes – Newswise

Posted: June 13, 2022 at 2:31 am

Newswise An investigative stem cell-based therapy called PEC-Direct, designed to act as a replacement pancreas, has the potential to provide blood sugar control in patients with high-risk type 1 diabetes, suggests a clinical study presented Saturday, June 11 at ENDO 2022, the Endocrine Societys annual meeting in Atlanta, Ga.

The study found multiple patients using the new treatment had clinically relevant increases in C-peptide, a substance made in the pancreas along with insulin. C-peptide and insulin are released from the pancreas at the same time and in about equal amounts, so measuring C-peptide can show how much insulin the body is making.

This research represents the first instance in multiple patients of clinically relevant increases in C-peptide, indicative of insulin production, with a stem cell-based therapy delivered in a device, according to Manasi Sinha Jaiman, M.D., M.P.H., Chief Medical Officer of ViaCyte, Inc., in San Diego, Calif., the company that makes PEC-Direct.

Patients with type 1 diabetes eventually lose the ability to produce their own insulin to control blood sugar levels. Patients must frequently check those levels with finger sticks, inject multiple insulin shots or carry around bulky devices. The injection of insulin also carries the risk of accidentally lowering blood sugar to dangerous levels.

The PEC-Direct device is designed to provide a long-term, stable source of insulin to regulate glucose levels. The device comprises a pouch containing stem-cell derived pancreatic cells which mature into insulin-producing cells once implanted into the body to regulate glucose levels. The open device membrane allows blood vessels to grow into the device to contact the cells. To prevent an immune reaction, patients take immunosuppressive drugs.

The treatment is meant for patients with high-risk type 1 diabetes, who may be especially vulnerable to acute complications due to factors such as recurrent severe low blood sugar, or frequent and extreme blood sugar fluctuations that are difficult to control.

The study included 10 adults with type 1 diabetes who had received their diagnosis at least 5 years prior to the start of the study and were not able to tell when their blood sugar went too low (called hypoglycemia unawareness). Initial data from one patient showed clinically relevant levels of stimulated C-peptide and corresponding improvements in blood glucose control within six months after implantation of PEC-Direct. Since then, increased C-peptide levels were seen in multiple patients, along with decreases in HbA1C (a blood test that measures average blood sugar levels over the past three months) by as much as 1.5%, and decreases in the amount of insulin patients needed to administer by as much as 70%.

The results suggest stem cell-based replacement therapy has the potential to provide blood glucose control and could one day eliminate the need for injecting or dosing insulin externally, Jaiman said. The study provides further proof-of-concept that continued optimization of PEC-Direct has promise as a functional cure for type 1 diabetes.

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Endocrinologists are at the core of solving the most pressing health problems of our time, from diabetes and obesity to infertility, bone health, and hormone-related cancers. The Endocrine Society is the worlds oldest and largest organization of scientists devoted to hormone research and physicians who care for people with hormone-related conditions.

The Society has more than 18,000 members, including scientists, physicians, educators, nurses and students in 122 countries. To learn more about the Society and the field of endocrinology, visit our site atwww.endocrine.org. Follow us on Twitter at@TheEndoSocietyand@EndoMedia.

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Stem-Cell Based Therapy Shows Promise in Treating High-Risk Type 1 Diabetes - Newswise

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