Chennai-based institute to begin clinical trial on stem cell therapy for liver disease – The New Indian Express

Express News Service

CHENNAI: Doctors at the Stem Cell Research Centre, Government Stanley Medical College Hospital (GSMCH), are in the process of recruiting patients for conducting phase I and II clinical trials of Stem Cell Therapy for end-stage liver disease to assess its safety and efficacy.

The clinical trial comes as a significant move as presently, liver transplant is the only treatment available for end-stage liver disease, but scarcity of donor organs necessitates alternative modalities. The Stem Cell Research Centre in July 2020 received approval from the Central Drug Standard Control Organisation (CDCSO) to conduct clinical trials after animal trails showed promising results, said Dr S Jeswanth, Director, Institute of Surgical Gastroenterology and Principal Investigator, Stem Cell Research Centre, GSMCH.

Dr Secunda Rupert, Co-Investigator at Stem Cell Research Centre, GSMCH told TNIE that liver transplant is currently the only option for end-stage liver disease. Many patients are on the waiting list for liver transplant. So these stem cells can be used as a bridge till they get donor liver for transplant and in some cases, it can be a wholesome therapy. We have found that in acute liver disease, the results are good, the doctor added.

According to data from the Transplant Authority of Tamil Nadu (TRANSTAN), there are 418 patients waiting for liver transplant in the State alone. The CDSCO gave approval and also directed to conduct more animal studies. We will first conduct them and then will start the clinical trials. We are in the process of recruiting patients for the trial. We couldnt recruit patients then because of the pandemic, said Secunda. A total of 30 patients will be recruited for clinical trials, and among them 15 will be put on Stem Cell Therapy and 15 on standard treatment, added Secunda.

Mesenchymal adult stem cells will be extracted from bone marrow of the patients and these will be cultured in the lab before being injected back into the patient, Secunda added. During animal studies, when we caused liver injury in the animal and injected the stem cells, there was an improvement in the injury. It showed these Mesenchymal adult stem cells can alleviate liver injury, Secunda further said. Jeswanth said the trial will be funded by the Tamil Nadu Innovative Initiative scheme (TANII).

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Chennai-based institute to begin clinical trial on stem cell therapy for liver disease - The New Indian Express

"Stem cell-based therapeutics poised to become mainstream option – BSA bureau

In conversation with Dr Koji Tanabe, Founder and CEO, I Peace, Inc., The United States/Japan

To make the trial investments more meaningful and to avoid ambivalence in animal models, medical science is adopting novel in vitro models of specialised human pluripotent cell lines. Pluripotent stem cells(PSCs) have the agility to expand indefinitely and differentiate into almost any organ-specific cell type. iPSC-derived organs andorganoidsare currently being evaluated in multiple medical research arena like drug development, toxicity testing, drug screening, drug repurposing, regenerative therapies, transgenic studies, disease modeling and more across clinical developments. Innovative pharmacovigilance methodologies are preferring induced pluripotent stem cells (iPSCs) for pre-clinical and clinical investigational studies. Global Induced Pluripotent Stem Cell (iPSC) market is expected to reach $2.3 B by 2026. The iPSC market inAsia-Pacificis estimated to witness fast growth due to increasing R&D projects across countries likeAustralia,JapanandSingapore.

I Peace, Inc. a Palo Alto-based global biotech company with its manufacturing base in Japan, has succeeded in developing and mass-producing clinical grade iPS cells through its proprietary iPS cell manufacturing services. The human iPSC (hiPSC) lines at I Peace leverage differentiated cells across clinical research and medical applications. Biopsectrum Asia discovered more about Japan's stem cell manufacturing ecosystem with Dr Koji Tanabe, Founder and CEO, I Peace, Inc., (The United States/Japan). Tanabe earned his doctorate under Dr Shinya Yamanaka, a Kyoto University researcher who received the 2012 Nobel Prize in Physiology or Medicine for discovery of reprogramming adult somatic cells to pluripotent cells. I Peace is focusing on this Nobel Prize-winning iPSCs technology where Tanabe had played a key role in generating the worlds first successful human iPSCs as one of the team members and is currently industrialising it in the US and Japan.

How do you define Japans Stem cell manufacturing dynamics aligning with regional and APAC market potential?

We believe that human cells play a pivotal role in next-generation drug therapy. Clinical trials of iPSC applications are in full swing not only in Japan, but worldwide as well. In the US, the momentum of clinical trial research is astounding. Yet, mass production of GMP compliant cell products remains a challenge. Entry into this venture is no easy task. As a contract development and manufacturing organisation (CDMO), I Peace is geared to tackle that challenge and become the pioneer of mass production technology of clinical grade cell products.

Can you elaborate I Peaces cost-effective proprietary stem cell synthesis solution and its manufacturing scale?

The key advantage of iPSCs is the ability to create pluripotent cells from an individuals own cells. Furthermore, iPSCs can multiply indefinitely and evolve into any type of cell, making iPSCs an ideal tool for transplant and regenerative medicine and drug research. However, clinical applications of iPSCs to date, utilise heterogenic transplantation. It is because manufacturing of just one line of iPSCs requires a cost intensive clean room to be occupied for several months. Manufacturing process complexities also pose a barrier to cost reduction and mass production.

In contrast, I Peace has developed a proprietary, fully automated closed system for iPS manufacturing, enabling cost-effective production of multiple lines of iPSCs from multiple donors in a single room. Within a few years, we expect to manufacture several thousand lines of iPSCs simultaneously in a single room. With this technology, I Peace can efficiently generate an ample supply of various iPSCs for heterogenic transplant, while also fostering a society where everyone can bank their own iPSCs for potential medical use.

How does I-Peace better position its businesses objectives and go-to-market strategies?

I Peaces manufacturing facility and its processes have undergone rigorous audits and are certified to be in compliance with GMP guidelines of the US, Japan, and Europe. We have the capacity to manufacture clinical-grade iPSCs and iPSC-derived cells for clinical use in the global market. Our manufacturing staff have unparalleled expertise in the manufacturing of iPSCs, and their knowledge and experience make it possible to mass produce high quality clinical-grade iPSCs in the shortest possible time. Additionally, we streamlined the iPSC use licensing scheme to expedite collaborative ventures with downstream partners. We believe these strategies position I Peace as a global leader in iPSC technology.

How do you outline the concept of democratising access to iPSC manufacturing?

At I Peace, we envision a world in which everyone would possess their own iPSCs and if needed, receive autologous transplant medication using their own iPSC. We believe in the importance of raising awareness of Nobel Prize winning iPSC technology and we think much more needs to be done. We need to enlighten the public about iPSCs - what they are, how they are created, and how they play a role in next-generation medical therapies. We also need to underscore the benefits of early banking ones own iPSCs, such as autologous transplant and the fact that cells taken in the early stages of life are preferable over cells collected later in life.

To democratise iPSC access, it is also important to expedite application research. We work closely with downstream partners, and support their iPSC-derived drug therapy development efforts by providing iPSCs to meet their needs. We also collaborate with downstream partners in the development of promising therapies including the use of T-cells for cancer therapy, cardiomyocytes for the treatment of heart disease, and neurocytes for neurological disease.

What is your outlook around boosting public-private stakeholders initiatives to encourage awareness on stem-cell-based therapeutics?

iPSC research has advanced tremendously over the past 16 years, and even more so since Dr Shinya Yamanakas Nobel Prize award in 2012. The acceleration of applied research is paving the way for stem cell-based therapeutics to become a common treatment modality in the near future. As human cell manufacturing requires specialised professional skills and knowledge, it is important to promote functional specialisation. These specialisations include donor recruiting, cell manufacturing (where I Peace is the key player), and implementing cell transplant as a medical practice. We believe that creating a systematic industry structure will build awareness and further drive the growth of stem cell-based therapy.

Can you brief Japans licensing key notes to manufacture and process clinical-grade cells in the region?

Japan enacted three laws to promote the use of regenerative medicine as a national policy:

1) The Regenerative Medicine Promotion Act -- representing the country's determination to promote regenerative medicine;

2) The Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act); and

3) The Act on the Safety of Regenerative Medicine (RM Act). The U.S. also has various tracks such as the Regenerative Medicine Advanced Therapy (RMAT) Designation, Breakthrough Therapy designation, and Fast Track designation.

Of significance, the PMD Act enables a fast-track for regulatory approval of regenerative medicalproducts in Japan. In compliance with the RM Act, I Peace was audited by the PMDA and licensed by the Ministry of Health, Labour, and Welfare to manufacture specific cell products.

Because cell product manufacturing regulations are not standardised globally, cell therapy developers are forced to source GMP iPSCs for each market. I Peace however, has overcome this hurdle. We have built in compliance with global GMP regulations, including FDA's cGMP regulations per 21 CFR 210/211 in our operation. As a result, we can provide cells for global use in multiple markets, accelerating both product development and regulatory approval.

Hithaishi C Bhaskar

hithaishi.cb@mmactiv.com

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"Stem cell-based therapeutics poised to become mainstream option - BSA bureau

Longeveron Successfully Advancing its Cell-Based Therapy Studies in a Growing Industry Segment – Yahoo Finance

Research and development of stem cell-based therapies, where a patients own cells, or those from a donor, are used to fight injury and disease, is one of the fastest growing areas in the biotech space. Longeveron Inc. (NASDAQ: LGVN), a clinical-stage biotechnology company in the thick of clinical development, continues to advance its investigational therapeutic, Lomecel-B, for chronic, aging-related and life-threatening conditions.

The company recently announced the results of its randomized, blinded and placebo-controlled Phase 2 trial to evaluate the safety and efficacy of its proprietary Lomecel-B infusion in frail, older patients between 70 and 85 years old. The trial, which was partially funded by the National Institute on Aging, evaluated a single intravenous infusion of 4 different doses of Lomecel-B cell therapy compared to placebo on the change in the distance a person could walk in 6 minutes (a test known as the 6-minute walk test). Results showed that a single infusion of Lomecel-B resulted in an increase in walk distance of approximately 50 meters (164 feet) at 6 and 9 months after infusion, while the placebo-treated subjects showed minimal improvement at 6 months and a deterioration by 9 months.

Lomecel-B is a proprietary allogeneic product comprised of medicinal signaling cells (MSCs) from the bone marrow of adult donors, which are culture-expanded in Longeverons current good manufacturing practice cell-processing facility. According to trial results so far, Lomecel-B, and MSCs in general, may be injected or infused into an unrelated recipient without triggering a harmful reaction (rejection) due to the biochemical properties of these specialized cells. This is in part what makes this class of biologic so intriguing for use as a regenerative therapeutic.

A growing global trend is for biotech companies to direct their services to the cell and gene therapy industry and moving to expand into a new branch of the pharmaceutical contract development and manufacturing organization world.

Story continues

The U.S. Food and Drug Administration (FDA) has approved a small number of cell and gene therapy drugs. Still, a new product pipeline is fighting for the agencys attention with approximately 1,200 experimental therapies more than half in Phase 2 clinical trials. The annual sales growth estimates for cell therapies are projected to reach 15%.

Longeveron has also initiated a Phase 2 trial evaluating the safety and efficacy of Lomecel-B injection into the heart of children born with hypoplastic left heart syndrome (HLHS), a rare and often fatal congenital heart defect.

Longeveron believes that using the same cells that promote tissue repair, organ maintenance and immune system function can develop safe and effective therapies for some of the most challenging diseases and conditions associated with aging.

We continue to make steady progress advancing our Lomecel-B clinical research programs forward, Longeveron CEO Geoff Green said. We have encouraging top-line results from our Aging Frailty program, and anticipate initiating a Phase 2 trial in Alzheimers disease later this year.

Longeveron shared their review of the Aging Frailty trial data with independent frailty experts, with the objective of planning the next steps for the program. The company presented clinical data at the 2021 International Conference on Frailty & Sarcopenia Research on Sept. 29 during a round-table presentation.

Learn more about Longeveron at http://www.longeveron.com.

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Longeveron Successfully Advancing its Cell-Based Therapy Studies in a Growing Industry Segment - Yahoo Finance

Anja Health Disrupts Cord Blood Banking with Heartfelt Founding Story and Ground-Breaking Mission – Digital Journal

This umbilical cord blood bank encourages parents to get the best healthcare option for their children.

When Anja Health founder Kathryn Cross was 3 and her brother was 1, he was in a near-drowning accident. His physicians quickly diagnosed him with cerebral palsy, and her parents began searching for a treatment. When they discovered umbilical cord blood, the possibilities that the future held suddenly widened. Umbilical cord blood was increasingly being studied as a treatment for cerebral palsy via clinical trials. Its versatile stem cells were already FDA-approved to treat 85+ diseases, and approximately 1,300 ongoing clinical trials were examining other use cases. Research for cerebral palsy in particular was promising, but the Cross family was ultimately unable to find an umbilical cord blood stem cell match that could have acted as a treatment.

When the founder later lost her brother to cerebral palsy and pneumonia complications, she realized that there was not only a limited supply of life-changing stem cells, but there was also limited awareness. In that moment, Anja Health was born.

Anja Health is a preventative care brand that offers Anja Health Family Defense, Anja Health Family Defense Plus, and Anja Health Family Defense Bundle to collect stem cells from the umbilical cord blood, cord tissue, and placenta.

With stem cell treatments unique ability to grow and develop into almost any cell type in the body, it has earned a reputation for being one of the most sought-after medical solutions and is now at the forefront of a brighter future for medicine. With its proven track record of saving lives, many parents now consider collecting their babys umbilical cord blood to preserve it for future use.

Anja Health collects, cryopreserves, and safe-keeps samples in its New-Jersey-based AABB-accredited, FDA-approved partner facility. It also updates its clients (even after birth and collection) of the newest stem cell uses to illustrate how clients can use samples when a need arises.

Stem cell treatments from banked cord blood, tissue, and placenta stem cells can be wonderfully life-altering for those who suffer from different diseases, said Anja Health founder Kathryn Cross. Today, banking is not simply an insurance policy in the low-probability case that your child gets a disease. Rather, if someone has access to stem cells and they stay up to date with its use cases as they develop, they will use stem cells at some point in their life.

Visithttps://anjahealth.com/for more information about the company and its services.

About Anja Health

Anja Health is a preventative care brand that provides services for collecting and preserving stem cells. Anja aims to bring the revolutionary benefits of stem cell treatments to individuals, especially those who suffer from various diseases.

Media Contact Company Name: Anja Contact Person: Kathryn Cross Email: Send Email Country: United States Website: https://anjahealth.com/

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Anja Health Disrupts Cord Blood Banking with Heartfelt Founding Story and Ground-Breaking Mission - Digital Journal

Ready to Treat Over 80 Life-Threatening Diseases, Discover the Potential of Cord Blood during World Cord Blood Day 2021 – PRNewswire

TUCSON, Ariz., Oct. 5, 2021 /PRNewswire/ --On November 15th, 2021, healthcare professionals and the general public are invited to participate in World Cord Blood Day 2021 (www.WorldCordBloodDay.org) via a free online conference and live educational events being held around the globe. Registration is now open (free, public welcome).

Cord blood is the blood left in the umbilical cord and placenta following the birth of a child. It is rich in life-saving stem cells. While cord blood has been used for over 30 years, Covid-19 has renewed interest in this medical resource given its unique regenerative qualities and the fact that most cord blood currently stored was collected prior to the pandemic. These units are naturally Covid-free, an advantage over many other stem cell sources. Yet, cord blood is still thrown away as medical waste in the majority of births worldwide. Education is key to changing this practice and World Cord Blood Day 2021 will provide the perfect opportunity for OBGYNs, midwives, transplant doctors, nurses, parents and students to learn about this vital medical resource.

During World Cord Blood Day 2021, participants will learn how cord blood is used to treat over 80 life-threatening diseases such as leukemia and lymphoma, bone marrow failure, immune deficiency diseases and inherited blood disorders such as thalassemia and sickle cell disease. Leading transplant doctors and researchers will also highlight cord blood's role in the emerging fields of gene therapy and regenerative medicine to potentially treat cerebral palsy, autism, stroke and more.

Organized by Save the Cord Foundation, a 501c3 non-profit, World Cord Blood Day 2021 is officially sponsored by QuickSTAT Global Life Science Logistics, recognized leader in medical shipping and healthcare logistics. Inspiring Partners include Be the Match (NMDP), World Marrow Donor Association (WMDA-Netcord), AABB Center for Cellular Therapies, Cord Blood Association, and the Foundation for the Accreditation of Cellular Therapy (FACT).

"QuickSTAT, part of Kuehne+Nagel, is proud to sponsor the 5th annual World Cord Blood Day to help support and educate the healthcare community and expectant parents about the life-saving value of cord blood stem cells. We're excited to play a role in the research and development of cord blood derivative therapies by providing logistics supply chain solutions to cord blood, biotech and pharmaceutical companies worldwide," said Monroe Burgess, VP Life Science Commercial Marketing, QuickSTAT.

Visit http://www.WorldCordBloodDay.org to learn how you can participate. Show your support on social media: @CordBloodDay, #WorldCordBloodDay, #WCBD21

About Save the Cord Foundation Save the Cord Foundation (a 501c3 non-profit) was established to advance cord blood education providing non-commercial information to health professionals and the public regarding methods for saving cord blood, as well as current applications and the latest research. http://www.SaveTheCordFoundation.org.

About QuickSTAT Global Life Science Logistics Every day, QuickSTAT, a part of Kuehne+Nagel, safely and reliably moves thousands of critical shipments around the world. For over forty years, QuickSTAT has been entrusted with transporting human organs and tissue for transplant or research, blood, blood products, cord blood, bone marrow, medical devices, and personalized medicine, 24/7/365. QuickSTAT's specially trained experts work with hospitals, laboratories, blood banks and medical processing centers, and utilize the safest routes to ensure integrity, temperature control and chain of custody throughout the transportation process. Learn more at http://www.quickstat.aero.

Contact: Charis Ober (520) 419-0269 [emailprotected]

SOURCE Save the Cord Foundation

http://www.SaveTheCordFoundation.org

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Ready to Treat Over 80 Life-Threatening Diseases, Discover the Potential of Cord Blood during World Cord Blood Day 2021 - PRNewswire

Transforming Growth Factor Sales Gaining Traction & to reach US$ 709.9 Mn with Significant Development in Cell Therapy Research – PRNewswire

Cell therapy plays an important role in vascular and hematopoietic, neural, skeletal, pancreatic, periodontal, and mucosal tissue regeneration. Platelet-derived growth factors and bone morphogenetic factors are gaining high demand for diabetic neuropathic ulcers and periodontal defects, and tissue regeneration at sites of tibia fractures. Increasing demand for transforming growth factors in regenerative medicine is expected to propel market growth substantially over the coming years.

Stem cell research continues to expand due to high adoption of stem cell treatment. Therefore, bone morphogenetic proteins (BMPs) and TGF-beta proteins are gaining demand and supporting the clinical development of cellular therapies. Cell culture has helped the most in oncology research as cancer cells are more responsive to culture in vitro, which, in turn, is drive demand in research areas.

Increasing healthcare R&D expenditure further improves the chances of breakthrough treatment options. Rapidly growing healthcare expenditure is resulting in new molecule discovery, evaluation of various molecules for possible disease treatment, and adoption of innovative approaches in these studies.

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Key manufacturers of transforming growth factor are focusing on the development of technology to cater to specific research requirements.

The COVID-19 pandemic affected health services for other diseases such as hypertension, cancer, diabetes, and cardiovascular diseases. Selective procedures such as orthopedic joint replacement were impacted. Shifted focus of healthcare professionals from these diseases to address the COVID-19 crisis negatively impacted the overall healthcare industry.

However, the transforming growth factor space did not see any long-term adverse effect on its business. A short-term impact of COVID-19 has been seen on the market due to disruptions in the supply chain and research activities during lockdowns. The market is projected to experience smooth growth over the coming years.

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Key Takeaways from Market Stud

By grade, the GMP segment is fast-growing at CAGR of 9.3%, on the back of rise is demand for supreme quality growth factors across regions.

Based on product, bone morphogenetic proteins (BMPs) is leading with over 43% market share.

Oncology research is estimated to lead the market by application. This segment accounted for approximately 22% share of the market.

Pharmaceutical and biotechnology companies lead demand for transforming growth factors with a market share of 48%.

By region, North America is set dominate the global market with a value share of around 41%. Europe is slated to be the second-largest leading region with a value share of 32%.

"Increasing drug discovery and stem cell research is expected to drive market expansion of transforming growth factors over the next ten years," says an analyst of Persistence Market Research.

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Market Competition

Agreements, collaborations, and partnerships have emerged as the key growth strategy adopted by industry players. By focusing on these strategies, key stakeholders are expanding their geographic footprints and strengthening their existing product portfolios.

In February, 2019, Roche entered into a definitive merger agreement to acquire Spark Therapeutics.

In 2021, Bio-Techne Corporation) and Catamaran Bio expanded their collaboration for the development of cell engineering and cell process technologies for use by Catamaran in the manufacturing of CAR-NK cell therapy products.

What Does the Report Cover?

Persistence Market Research offers a unique perspective and actionable insights on the transforming growth factor market in its latest study, presenting historical demand assessment of 2016 2020 and projections for 2021 2031.

The research study is based on the product (activin, bone morphogenetic proteins (BMPs), TGF-beta proteins), grade (GMP grade, NON-GMP grade), application (oncology research, haematology research, wound healing research, dermatology research, cardiovascular disease & diabetes, cell therapy and ex vivo manufacturing, others), end user (pharmaceutical and biotechnology companies, research centres & academic institutes, CMOs and CDMOs), across seven key regions of the world.

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Persistence Market Research is always way ahead of its time. In other words, it tables market solutions by stepping into the companies'/clients' shoes much before they themselves have a sneak pick into the market. The pro-active approach followed by experts at Persistence Market Research helps companies/clients lay their hands on techno-commercial insights beforehand, so that the subsequent course of action could be simplified on their part.

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Transforming Growth Factor Sales Gaining Traction & to reach US$ 709.9 Mn with Significant Development in Cell Therapy Research - PRNewswire

StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa – WITN

StemExpress to use utilize the Thermo Fisher Accula rapid PCR testing system to provide event attendees with accurate results in 30 minutes.

Published: Oct. 5, 2021 at 3:33 PM EDT|Updated: 3 hours ago

SACRAMENTO, Calif., Oct. 5, 2021 /PRNewswire/ --StemExpress is proud to announce that they will be the official COVID-19 testing provider for 2021's Meeting on the Mesa, a hybrid event bringing together great minds in the cell and gene biotech sphere. It has partnered with Alliance for Regenerative Medicine to comply with the newly implemented California state COVID-19 vaccination and testing policy regarding gatherings with 1,000 or more attendees. This partnership will allow the vital in-person networking aspect of the event to commence while protecting the health and safety of participants and attendees.

In-person networking commences at the 2021 Cell and Gene Meeting on the Mesa with COVID-19 testing options provided by StemExpress.

As a leading global provider of human biospecimen products, StemExpress understands the incredible impact that Meeting on the Mesa has on the industry and has been a proud participant for many years. For over a decade, StemExpress has provided the cell and gene industry with vital research products and holds valued partnerships with many of this year's participants. As such, it understands the immense value that in-person networking provides and is excited to help bring this element back to the meeting safely and responsibly.

StemExpress has been a trusted provider of widescale COVID-19 testing solutions since early 2020 - providing testing for government agencies, public health departments, private sector organizations, and the public nationwide. For Meeting on the Mesa, StemExpress is offering convenient testing options for unvaccinated attendees and those traveling from outside of the country. Options will include take-home RT-PCR COVID Self-Testing Kits and on-site, rapid PCR testing for the duration of the event. The self-testing kit option allows attendees to test for COVID in the days leading up to the event for a seamless admission and the days following the event to confirm they haven't been exposed. The on-site rapid testing option utilizes the new Thermo Fisher Accula, offering in-person testing at the event with results in around 30 minutes. StemExpress is excited to bring these state-of-the-art COVID testing solutions to the frontlines of the Cell & Gene industry to allow for safe in-person connections.

The StemExpress partnership with Alliance for Regenerative Medicine seeks to empower the entire cell and gene industry with a long-awaited opportunity to return to traditional networking practices. It is well known that innovation doesn't exist in a vacuum - allowing great minds to come together is a sure way to spur scientific growth and advance cutting-edge research, giving hope for future cures.

Cell and Gene Meeting on the Mesa will take place October 12th, 2021, through October 14th, 2021, at Park Hyatt Aviara,7100 Aviara Resort Drive Carlsbad, CA 92011. To learn more about the event, please visit MeetingOnTheMesa.com.

For more information about COVID testing solutions for businesses and events, visit https://www.stemexpress.com/covid-19-testing/.

About StemExpress:

Founded in 2010 and headquartered in Sacramento, California, StemExpress is a leading global biospecimen provider of human primary cells, stem cells, bone marrow, cord blood, peripheral blood, and disease-state products. Its products are used for research and development, clinical trials, and commercial production of cell and gene therapies by academic, biotech, diagnostic, pharmaceutical, and contract research organizations (CRO's).

StemExpress has over a dozen global distribution partners and seven (7) brick-and-mortar cellular clinics in the United States, outfitted with GMP certified laboratories. StemExpress runs its own non-profit supporting STEM initiatives, college and high school internships, and women-led organizations. It is registered with the U.S. Food and Drug Administration (FDA) and is continuously expanding its network of healthcare partnerships, which currently includes over 50 hospitals in Europe and 3 US healthcare systems - encompassing 31 hospitals, 35 outpatient facilities, and over 200 individual practices and clinics.

StemExpress has been ranked by Inc. 500 as one of the fastest-growing companies in the U.S.

About the Alliance for Regenerative Medicine:

The Alliance for Regenerative Medicine (ARM) is the leading international advocacy organization dedicated to realizing the promise of regenerative medicines and advanced therapies. ARM promotes legislative, regulatory, reimbursement and manufacturing initiatives to advance this innovative and transformative sector, which includes cell therapies, gene therapies and tissue-based therapies. Early products to market have demonstrated profound, durable and potentially curative benefits that are already helping thousands of patients worldwide, many of whom have no other viable treatment options. Hundreds of additional product candidates contribute to a robust pipeline of potentially life-changing regenerative medicines and advanced therapies. In its 12-year history, ARM has become the voice of the sector, representing the interests of 400+ members worldwide, including small and large companies, academic research institutions, major medical centers and patient groups. To learn more about ARM or to become a member, visit http://www.alliancerm.org.

Media Contact: Anthony Tucker, atucker@stemexpress.com

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SOURCE StemExpress

The above press release was provided courtesy of PRNewswire. The views, opinions and statements in the press release are not endorsed by Gray Media Group nor do they necessarily state or reflect those of Gray Media Group, Inc.

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StemExpress Partners with the Alliance for Regenerative Medicine to Provide COVID-19 Testing for the Cell and Gene Meeting on the Mesa - WITN

Indianapolis mother gives 13-year-old son with sickle cell disease a 2nd chance at life – WTHR

Myles Glass has spent the past several years living life on the sidelines in a wheelchair, wishing for a better day. That day came in November 2020.

INDIANAPOLIS A 13-year-old boy living with sickle cell disease has been given a second chance at life, thanks to his mother.

Myles Glass has been through more in his young life than most adults. For the past few years, Glass has spent his days in and out of Riley Hospital for Children.

"[I] kind of have to look on the bright side of things. Being in the hospital, I meet new nurses and kids who go through what I go through. It's kind of hard to go through that at my age," Glass said.

He was diagnosed with sickle cell disease as a newborn. According to the Centers for Disease Control and Prevention, African Americans make up the largest number of people with the disease in the U.S.

Sickle cell disease is an inherited condition that impacts red blood cells and causes pain, infections and extreme fatigue. These symptoms keep Glass from doing things he loves.

"For him, it's kind of like we have to have him in a bubble," said his mother, Melissa Sanders.

Glass has spent the past several years living life on the sidelines in a wheelchair, wishing for a better day.

"[I would] hope that one day, I can do what kids do, like playing football and basketball," Glass said.

That day came in November 2020 when his mother donated bone marrow for a stem cell transplant, curing him of sickle cell disease.

"I was able to give him a second life with being a donor so that he can somewhat be a normal kid," Sanders said.

Riley Hospital for Children Dr. Seethal Jacob, who has been working with Glass and his family, said one baby every two minutes is born with sickle cell disease. She also said studies show there is a clear disparity for funding for this disease.

"There's been a lot of neglect when it comes to the disease itself. I think it's important to pay attention to the population it affects. I think that likely tells the story why sickle cell disease has been a neglected disease for so long," Jacob said.

Despite his challenges, Glass is staying positive and making strides in his physical therapy at Riley Hospital for Children.

"He's already been through harder things than most people will ever go through. I think anything else in life is going to be a piece of cake," said his physical therapist, Sarah Johnson.

"This gives me a glimpse of hope that even though you may have been diagnosed with this disease, it's not the end of the world," Sanders said.

For Glass, this is just the beginning. He hopes his story encourages other people living with sickle cell disease to keep moving forward.

"I know it's hard now, but you'll get through it. You'll be able to do what kids do your own age," Glass said.

Click here for more information on sickle cell disease and treatment options.

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Indianapolis mother gives 13-year-old son with sickle cell disease a 2nd chance at life - WTHR

Brazil investigates the use of stem cells in the treatment of covid-19 The Clare People – The Clare People

On Friday (1), the National Health Surveillance Agency (Anvisa) approved a clinical study for a treatment with stem cells, aimed at patients with viral pneumonia due to covid-. Tests against the SARS-CoV-2 coronavirus should take place in 4 Brazilian states, including Paran, Rio Grande do Sul, Bahia and Rio de Janeiro.

In the Phase1/2 research, the safety and efficacy of potential advanced cell therapy is evaluated solutions based on human cells or genes, such as stem cells. According to Anvisa, the initial study of the treatment is sponsored by the Paran Association of Culture (APC) of the Pontifical Catholic University of Paran (PUC/PR).

Research by PUC Paran tests the efficacy and safety of stem cells against covid-1024 (Image: Reproduction/Andrea Piacquadio/Pexels)

In the study of stem cells against covid-, researchers will be able to recruit up to 60 volunteers. To participate, the person must have a diagnosis of viral pneumonia caused by the Sars-CoV-2 coronavirus, confirmed by RT-PCR tests, in a moderate or severe situation. In addition, you will be required to sign a consent form.

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This is a phase 1/2a clinical trial with a mesenchymal stem cell-based product Allogeneic, with the main objective of evaluating the safety in the treatment of patients with pneumonia caused by SARS-CoV-2, informs Anvisa. In general, these cells are derived from the tissue of the umbilical cord (TCU) of newborns.

The following clinical centers participate in the study:

Hospital Espaol, in Salvador, Bahia;

Porto Alegre Hospital de Clnicas, in Porto Alegre, Rio Grande do Sul;

According to the safety data collected in the clinical trial, an independent committee will evaluate the continuity of the research. In addition, Anvisa highlighted that the aspects related to ethics in research with human beings were the evaluated and the trial was approved by the National Research Ethics Committee of the Ministry of Health (Conep/MS).

So far, Anvisa has not approved any treatment with stem cells for any of the phases of covid-1024. This is because no evidence has been presented to confirm the safety and efficacy, so far. In this sense, the use of such treatments can put people at serious risk and constitutes a sanitary and criminal offence.

For clinical use in the population, it is necessary that there is unequivocal proof of the safety, efficacy and quality of the products. During the development phase and through controlled research, the products are defined the clinical indications, the main adverse reactions observed, the special care with the patient during and after use, as well as the critical attributes of the products quality, completes the agency on the importance of regulation.

Source: Anvisa

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Brazil investigates the use of stem cells in the treatment of covid-19 The Clare People - The Clare People

US FDA Approves Kite’s Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | DNA RNA and…

Details Category: DNA RNA and Cells Published on Monday, 04 October 2021 20:29 Hits: 291

-- 65% of Patients Achieved Overall Complete Remission with Tecartus --

-- High Unmet Need: Fifty Percent of Adult Patients Will Relapse on Currently Available Treatments --

-- Approval Marks Kites Fourth Indication for its Cell Therapies and First in Leukemia --

SANTA MONICA, CA, USA I October 01, 2021 I Kite, a Gilead Company (Nasdaq: GILD), today announced the U.S. Food and Drug Administration (FDA) has granted approval for Tecartus (brexucabtagene autoleucel) for the treatment of adult patients (18 years and older) with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Following FDA Breakthrough Therapy Designation and a priority review, Tecartus is the first and only chimeric antigen receptor (CAR) T-cell therapy approved for adults (18 years and older) with ALL. There is a high unmet need, as half of this patient population will relapse, and median overall survival (OS) is only approximately eight months with current standard-of-care treatments. Patients can access Tecartus through 109 authorized treatment centers across the U.S.

Adults with ALL face a significantly poorer prognosis compared to children, and roughly half of all adults with B-ALL will relapse on currently available therapies, said Bijal Shah, MD, ZUMA-3 investigator and medical oncologist, Moffitt Cancer Center, Tampa, Florida. We now have a new meaningful advancement in treatment for these patients. A single infusion of Tecartus has demonstrated durable responses, suggesting the potential for long-term remission and a new approach to care.

The approval is based on results from ZUMA-3, a global, multicenter, single-arm, open-label study in which 65% of the evaluable patients (n=54) achieved complete remission (CR) or CR with incomplete hematological recovery (CRi) at a median actual follow-up of 12.3 months. The duration of CR was estimated to exceed 12 months for more than half the patients. Among efficacy-evaluable patients, median duration of remission (DOR) was 13.6 months. Among the patients treated with Tecartus at the target dose (n=78), Grade 3 or higher cytokine release syndrome (CRS) and neurologic events occurred in 26% and 35% of patients, respectively, and were generally well-managed.

Today marks Kites fourth FDA approved indication in cell therapy in under four years, demonstrating our commitment to advancing CAR T for patients across many different hematologic malignancies, said Christi Shaw, Chief Executive Officer of Kite. Tecartus has already transformed outcomes for adults living with mantle cell lymphoma, and we look forward to offering the hope for a cure to patients with ALL.

Adults with relapsed or refractory ALL often undergo multiple treatments including chemotherapy, targeted therapy and stem cell transplant. CAR T-cell therapy works differently, by harnessing a patients own immune system to fight cancer. With CAR T, the patients blood is drawn and the T cells are separated. Then the T cells are genetically engineered with a specific receptor that enables them to identify and attack cancer cells, and put back into the patients body.

Roughly half of all ALL cases actually occur in adults, and unlike pediatric ALL, adult ALL has historically had a poor prognosis, said Lee Greenberger, PhD, Chief Scientific Officer of The Leukemia & Lymphoma Society (LLS). Developing new therapies that would be life-changing for people with cancer has been a dream of LLS. We are proud to see the potential of CAR T realized for even more people with this approval for brexucabtagene autoleucel.

Tecartus is also currently under review in the European Union and United Kingdom for the treatment of adult patients with relapsed or refractory B-cell precursor ALL.

The Tecartus U.S. Prescribing Information has a BOXED WARNING for the risks of CRS and neurologic toxicities, and Tecartus is approved with a Risk Evaluation and Mitigation Strategy (REMS) due to these risks; see below for Important Safety Information.

Additional Information About ZUMA-3 Trial

Further efficacy results from the ZUMA-3 trial have been published and presented in scientific forums. Published Phase 1 data showed 32% of responders (n=22) were still in remission at the median follow-up of 22.1 months. In Phase 2 data presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, investigators reported that among treated patients (n=54), 31% of these patients were in ongoing response at a median follow-up of 16.4 months. 97% of responders had deep molecular remission, with undetectable minimal residual disease (MRD), and median OS among all responders has not yet been reached. A safety analysis, reported in the Lancet, showed among all patients who experienced a neurologic event, 94% of CRS events and 88% of neurologic events were resolved.

ZUMA-3 is an international multicenter, registrational Phase 1/2 study in adult patients (18 years old) with ALL whose disease is refractory to or has relapsed following first standard systemic therapy with remission of 12 months or less, after two or more lines of systemic therapy or at least 100 days after allogeneic stem cell transplantation. Seventy-one patients were enrolled (and leukapheresed) in the study, and the primary endpoint was overall complete remission rate (OCR, equaling complete remission plus complete remission with incomplete hematologic recovery) as determined by an independent review.

About ALL

ALL is an aggressive type of blood cancer that can also involve the lymph nodes, spleen, liver, central nervous system and other organs. Approximately 1,000 adults are treated annually for relapsed or refractory ALL. B-cell precursor ALL is the most common form, accounting for approximately 75% of cases, and treatment is typically associated with inferior outcomes compared with other types of ALL. Survival rates remain very poor in adult patients with relapsed or refractory ALL, with median OS at less than eight months.

About Tecartus

Tecartus is an autologous, anti-CD19 CAR T-cell therapy. Tecartus uses the XLP manufacturing process that includes T cell enrichment, a necessary step in certain B-cell malignancies in which circulating lymphoblasts are a common feature. Tecartus is also being evaluated in pediatric ALL, where its use is investigational, and its safety and efficacy have not been established.

About Kite

Kite, a Gilead Company, is a global biopharmaceutical company based in Santa Monica, California, with commercial manufacturing operations in North America and Europe. Kites singular focus is cell therapy to treat and potentially cure cancer. As the cell therapy leader, Kite has more approved CAR T indications to help more patients than any other company. For more information on Kite, please visit http://www.kitepharma.com.

About Gilead Sciences

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.

Tecartus Indication

Tecartus is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of:

This indication is approved under accelerated approval based on overall response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

SOURCE: Kite Pharma

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US FDA Approves Kite's Tecartus as the First and Only Car T for Adults With Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia | DNA RNA and...