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GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in Liver Diseases

Lille, France; Cambridge, MA; September 19, 2022 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases, today announced it has entered into an exclusivity agreement with a view to acquire all the share capital and voting rights of Versantis, a private Swiss-based clinical stage biotechnology company focused on addressing the growing unmet medical needs in liver diseases.

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GENFIT to Acquire Clinical-stage Biopharmaceutical Company Versantis, expanding its Portfolio in Liver Diseases

Stem Cell Therapy for Eye Disease: What You Need to Know

Avoid Unlicensed Clinics Offering Unapproved Stem Cell Therapy

Stem cell therapies are getting headlines for their potential to cure diseases, including those that affect vision. But an important message is missing: the therapies are not yet proven to be safe and effective for your eyes.

Stem cell treatments appear to offer hope to people with few options to recover vision. This includes people with forms of age-related macular degeneration (AMD), retinitis pigmentosa (RP), and Stargardt disease. Some clinics across the United States offer "stem-cell therapy" to people outside of clinical trials. But the Food and Drug Administration (FDA) has not approved the treatments they offer. These treatments often use unproven products that may be ineffective or dangerous. These products may carry serious risks, including tumor growth.

It is important that you know that there are no stem cell products approved by the FDA for eye disease right now. If you want stem cell therapy, look for a clinical trial and discuss the matter with your ophthalmologist. A clinic should not expect you to pay thousands of dollars for an unproven, unapproved therapy. Your health insurance will not cover the cost of an unapproved treatment.

Before agreeing to a stem cell treatment, ask yourself:

It is frustrating and frightening to face the loss of vision while waiting for potential treatments. However, choosing to pursue an unproven treatment in an unlicensed clinic is an unacceptable risk to your vision and your overall health.

The American Academy of Ophthalmology wants to reduce or eliminate unlicensed stem cell clinics in the United States. In June 2016, the Academy asked the FDA to tighten regulations and increase investigations into stem cell treatments given outside of clinical trials.

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Stem Cell Therapy for Eye Disease: What You Need to Know

How Does Stem Cell Therapy Work and What Are the Risks? | ISCRM

Human stem cells are essential for the growth and maintenance of our organs, bones, and systems. They are also amazing tools of discovery for scientists at the Institute for Stem Cell and Regenerative Medicine and researchers around the world studying how to stop diseases. However, predatory businesses across the country are misusing the term stem cells to market unapproved, unproven, and unsafe procedures that are often expensive and largely ineffective. Its important to understand what stem cell therapy really means.

Lets start by creating two categories of stem cell therapies approved (by the FDA) and unapproved. Whether a stem cell therapy is approved or unapproved has critical implications for the science, effectiveness, and safety of the procedure.

(In addition to blood stem cell transplants), the FDA lists a limited number of additional approved products on its website.)

More recently, hundreds of businesses around the country referring to themselves as clinics have begun marketing various versions of stem cell therapy that promise to help patients with serious conditions like Parkinsons disease and more common ailments like joint pain. In reality, most of these types of stem cell therapy do not use stem cells at all. Rather, they remove tissues that presumably contains adult stem cells from one body part and inject those cells into another part of the body.

Furthermore, there is no proof that any stem cell therapy offered by stem cell clinics is effective or safe. Unlike FDA-approved procedures, which are subject to years of rigorous trials, unapproved treatments marketed directly to patients are developed and performed with little oversight. While stem cell clinics often tout testimonials from satisfied customers, there has never been a large-scale clinical trial to demonstrate that the perceived benefits of a stem cell therapy arent the result of a placebo effect. In recent years, the FDA has begun to expand regulations and enforcement of these clinics.

Thanks to decades of data, we know much more about the effectiveness of blood stem cell transplants. We also know they are not instant cures. While the procedure itself only lasts a few hours, recovery can take weeks. During this period, patients are monitored closely by physicians and nurses for side effects and for evidence of recovery.

There are side effects associated with approved and unapproved stem cell therapies. The possible side effects of blood stem cell transplants are detailed on the Cancer.org website. Patients considering an unapproved stem cell therapy should be aware that these procedures carry serious risks and that these risks may not be managed by a qualified care team. Injecting even a persons own tissue in a different body part has resulted in severe illness and, in some cases, blindness.

Therapies offered by stem cell clinics come with financial risk as well. Because these procedures are generally not covered by insurance, people seeking treatment are required to pay large out-of-pocket fees with no guarantee of improved health.

In their advertising, stem cell clinics promise unsubstantiated relief or even cures for everything from knee pain to Parkinsons disease, often taking advantage of vulnerable individuals who may feel they have nowhere else to turn. In reality, there is no strong evidence to back up claims that any stem cell therapy works let alone has lasting benefits.

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How Does Stem Cell Therapy Work and What Are the Risks? | ISCRM

CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte – PR Newswire

SINGAPORE, Sept. 16, 2022 /PRNewswire/ --CellResearch Corporation, a Singapore-based biopharmaceutical company today announced it has successfully closed the first Phase I study in CorLiCyte, a stem cell therapy derived from umbilical cord lining stem cells, with research partners at the University of Colorado, Anschutz Medical Campus and ClinImmune Cell and Gene Therapy.

CorLiCyte is in development for the treatment of a number of serious conditions, with a first target indication of treating diabetic foot ulcer (DFU). In the study protocol nine patients with chronic DFU were treated with CorLiCyte twice weekly for 8 weeks. None of the patients participating in the study experienced any treatment-related adverse events and all subjects saw a reduction in wound size during the treatment period.

"These results are encouraging and can be used to support further research with CorLiCyte in future studies, with the potential to address unmet medical needs in treatment of patients with chronic DFUs." said Cecilia Low-Wang, the lead investigator at the University of Colorado, Anschutz Medical Campus.

About CorLiCyte

CorLiCyte is a live mesenchymal stem cell therapy derived from human umbilical cord lining stem cells, with a proprietary optimised expression of cytokines, growth and cellular factors for the treatment of a number of serious health conditions. In addition to DFU, CRC is pursuing a range of potential indications at pre-clinical stage such as osteoarthritis, venous leg ulcers, chronic inflammatory and autoimmune conditions.

About CellResearch Corporation

CellResearch Corporation (CRC) was founded in 2002 as a contract research provider focusing on skin cells. In 2004, the company made the discovery that the umbilical cord lining of mammals was an abundant source of both mesenchymal and epithelial stem cells. Today, the company owns this technology through a family of patents and holds the rights to commercialise this technology in most major markets globally.

CellResearch Consumer Health (Formerly known as CALECIM Cosmeceuticals) is a wholly owned subsidiary of CRC and produces an innovative range of skin and hair care products using cord lining stem cell media to power its products. It is used in medical hair and aesthetic clinics for in-office treatments and as part of an at-home anti-aging skincare regime. It is distributed globally through over 600 aesthetic physicians and online via its own website. It has a key distribution partnership with Menarini Group across South East Asia.

CRC partner, Cordlife offers parents the opportunity to bank their child's umbilical cord tissue alongside their cord blood. Cordlife has what is believed to be the largest licensed bank of umbilical cord tissue globally. As cell therapies move into the clinic, Cordlife will have the ability to expand stem cells from a banked umbilical cord for autologous and donor-related uses.

Contact:

Business Development and Investor Relations: Xavier Simpson Tel: +65 8815 6139 Email: [emailprotected]

http://www.cellresearchcorp.com http://www.calecimprofessional.com

SOURCE CellResearch Corporation

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CellResearch Corporation (CRC) announces positive results of Phase I study for CorLiCyte - PR Newswire

Predicting the Treatment Evolution of Hemophilia B – Managed Healthcare Executive

Steven Pipe, MD, describes his hopes for Hemophilia B treatment in the future.

EP. 1 : An Overview of Hemophilia B

EP. 2 : The Economic Burden of Hemophilia B From a Payer Perspective

EP. 3 : Defining the Impact of Gene Therapy

EP. 4 : Managing Hemophilia B Using Gene Therapy

EP. 5 : Predicting the Treatment Evolution of Hemophilia B

Steven Pipe, MD: The current platform looks promising for durable correction in factor 9 levels that are sufficient to prevent most bleeding events and improve health-related quality of life, with a substantial elimination of the economic and personal treatment burden associated with factor 9 prophylaxis. However, with the eligibility limitations we've also indicated, the biggest one, for me, is that this is only for adults. By adulthood, a substantial portion of patients already have established joint disease. We would have a much bigger impact from gene therapy if we could do an earlier intervention in the pediatric age group. Unfortunately, with the way the AAV mechanism occurs by targeting the liver, the DNAthat's the transientis delivered into the nucleus and remains episomal, which means it's primarily outside of the genome. When dividing liver cells, the transgene doesn't get propagated to the daughter cells. What that would mean is, if we did AV in a pediatric age group with a growing, dividing liver, the effect of the gene therapy will be deluded over time. We need different approaches for gene therapy to impact the pediatric age group.

Some of the things I've seen that show promise are non-viral approaches. By using a non-viral approach, you have the option to re-treat patients. That is not an option for patients who get current AV therapy because once you've delivered the AV once, the immunological consequences of that would preclude getting another AV dose sometime later. Right now, we're asking patients to make a once-in-a-lifetime treatment decision to receive gene therapy, but other approaches could also involve gene editing. When you do gene editing, you're either inserting the transgenes somewhere in the genome or modifying the factor 9 gene in such a way that you can restore factor 9 expression. Because you're editing directly in the genome, that would be propagated to daughter cells in a dividing liver. I'm already seeing some new protocols come to the forefront [that will be implemented] in the clinic soon. If these show their utility in adult patients, we'll see that these offered to younger and younger patients and, hopefully, the pediatric age groups where we can completely abrogate the development of joint disease.

The other thing I'm excited about is the evolving treatment landscape as applied to hemophilia B, not just invested in gene therapy approaches. There are several innovative treatment platforms that have been tested over the last few years. The ones I'm particularly excited about are non-factor placement therapies. These are cross-platform therapeutics that can work for hemophilia A or B regardless of whether the patient has had any prior inhibitor development to the factor 8 or factor 9 proteins. These primarily target the natural anticoagulants of the hemostatic process. They rebalance hemostasis without replacing the factor 9 molecule. Data that was presented at this most recent ISTH Congress [International Society of Thrombosis and Haemostasis] in July of this year showed encouraging results that can be applied to patients with hemophilia B. These are treatments that can be delivered subcutaneously. They have a lower intensity. Some of them are given either weekly, monthly, or once every other montha low burden of treatment. They [provide] effective prophylaxis that, in some studies, is superior to traditional factor 9 replacement therapy. I'm excited about the evolving treatment landscape. Hemophilia B gene therapy [carries] great promise, but these other novel therapeutics are hopefully going to be available to us in the clinics quite soon.

Transcript edited for clarity.

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Predicting the Treatment Evolution of Hemophilia B - Managed Healthcare Executive

$150 Million Gift Takes Stem Cell Research to New Heights – University of California San Diego

From left, T. Denny Sanford, Catriona Jamieson, MD, PhD, and Chancellor Pradeep K. Khosla celebrate the establishment of the UC San Diego Sanford Stem Cell Institute, made possible by a historic gift from Sanford.

Noted businessman and philanthropist T. Denny Sanford has committed $150 million in new funding to expand and, in some ways, quite literally launch stem cell research and regenerative medicine at University of California San Diego into new spaces and endeavors.

The gift will fund the new UC San Diego Sanford Stem Cell Institute and builds upon a $100 million gift in 2013 from Sanford that boldly established UC San Diego as a leader in developing and delivering the therapeutic promise of human stem cells special cells with the ability to develop into many different cell types and which, when modified and repurposed, have the potential to treat, remedy or cure a vast array of conditions and diseases.

Dennys previous generosity spurred discoveries in stem cell research and medicine at UC San Diego that are already benefiting countless patients around the world, said Chancellor Pradeep K. Khosla. His most recent gift adds to our portfolio of stem cell research conducted in Earths orbit that will help us better understand the progression of cancer cells and aging.

Sanfords gift to establish the Sanford Stem Cell Institute is the largest single gift to UC San Diego. This investment enables the team to dream beyond what is possible, said Sanford. The sky is no longer the limit.

In addition to his investment to create the Sanford Stem Cell Clinical Center at UC San Diego Health in 2013, Sanford established the T. Denny Sanford Institute for Empathy and Compassion in 2019, which focuses on research into the neurological basis of compassion, with application toward developing compassion and empathy-focused training for future generations of medical professionals. He also recently made a $5 million gift to support the Epstein Family Alzheimers Research Collaboration, a partnership between UC San Diego and the University of Southern California to spark new collaborative efforts to discover effective therapies for Alzheimers disease.

Sanford was also honorary co-chair of the Campaign for UC San Diego, which concluded in June 2022 having raised more than $3 billion exceeding its initial $2 billion goal. He was honored as a recipient of the 2014 Chancellors Medal, one of the universitys highest honors, in recognition of his exceptional service in support of the campus mission.

Stem cell research will be conducted in a laboratory bay located aboard the International Space Station, pictured here, in low-Earth orbit. Credit: NASA

The new UC San Diego Sanford Stem Cell Institute, under the direction of Catriona Jamieson, MD, PhD, Koman Family Presidential Endowed Chair in Cancer Research in the UC San Diego School of Medicine, will continue three existing stem cell programs at UC San Diego with three new programs.

The new programs to be established with Sanfords gift include:

Existing stem cell programs at UC San Diego in the Sanford Stem Cell Institute include:

We are thrilled to announce the establishment of the UC San Diego Sanford Stem Cell Institute with Denny Sanfords generous support, said Jamieson. This will allow us to keep pace with the growing need for regenerative and stem-cell based therapies and accelerate translational stem cell research and discoveries that will transform human health for years to come.

With three new programs established as part of the Sanford Stem Cell Institute, a key focus of the institute will be leveraging space as a new frontier for stem cell science. Exposure to radiation and microgravity in low-Earth orbit can simulate and speed up aging in stem cells, as well as their transformation into cancer cells. Space-related research may have applications that create better treatments for various cancers and diseases on earth, including blood cancers, as well as neurodegenerative diseases such as Alzheimers and Parkinsons.

To fuel sustained research and education in this promising area, Sanfords gift will establish the Sanford Stem Cell Institute STELLAR Endowed Chair in Regenerative Medicine, the Sanford Stem Cell Institute Endowed STELLAR Exploration Faculty Scholars and Fellows Fund, and the Sanford Stem Cell Institute STELLAR Exploration Discovery Fund.

UC San Diego already has expanded its research capacity in stem cell science to space efforts that will be further amplified with the recent gift.

In late 2021, UC San Diego worked with NASA, Space Tango and the JM Foundation to launch stem cells into space aboard a SpaceX Falcon 9 rocket to study stress-induced aging and how stem cells and their progeny transform into pre-cancer and cancer stem cells associated with leukemia and other blood cancers.

Allyson Muotri, PhD, with human organoid samples

In 2019, Alysson Muotri, PhD, professor of pediatrics and cellular and molecular medicine, and colleagues sent a payload of stem cell-derived human brain organoids to the International Space Station (ISS) orbiting almost 250 miles above Earth to study how these masses of cells organize into the beginnings of a functional brain in microgravity. The first-ever project of its type was dedicated to Sanford, a longtime supporter of Muotris work and others.

When I was designing these experiments, I realized how innovative and cutting edge they were, said Muotri. I thought Denny would be proud of this project, and that I should dedicate this first mission to him. Denny has been a cheerleader for the stem cell community. He is pushing all of us to speed discovery and translate it to help millions of people who suffer from different conditions that could be treated with stem cell-based therapies.

Since its inception in 2013, the Sanford Stem Cell Clinical Center at UC San Diego has yielded a three-fold return on investment by obtaining more than $312 million in funding, including $253.6 million in grants, $15.8 million in clinical trial contracts, $2.7 million in Advanced Cell Therapy Lab (ACTL) service charges and more than $40.2 million in philanthropy all with the goal of discovering new treatments to benefit patients.

Key successes include new pharmaceutical treatments Fedratinib, which was approved by the FDA for the treatment of myelofibrosis in 2019, and Glasdegib, FDA approved for acute myeloid leukemia in 2018.

Meanwhile, clinical trials are ongoing for Cirmtuzumab, a monoclonal antibody-based drug developed by Thomas Kipps, MD, PhD, Distinguished Professor of Medicine and deputy director of research at Moores Cancer Center at UC San Diego Health, and colleagues. Cirmtuzumab targets cancer stem cells and is being tested, alone and in combination with other drugs, to treat chronic lymphocytic leukemia and other blood cancers.

Stem cell research at UC San Diego has been a substantial beneficiary of the California Institute for Regenerative Medicine (CIRM), the states stem cell agency, created in 2004 with the approval of Proposition 71. UC San Diego researchers have garnered 116 awards totaling more than $227 million. Cirmtuzumab is named as a nod to CIRM and its support. In 2020, California voters passed Proposition 14 to continue CIRM operations and funding.

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$150 Million Gift Takes Stem Cell Research to New Heights - University of California San Diego

Clinical translation of stem cell therapy for spinal cord injury still premature: results from a single-arm meta-analysis based on 62 clinical trials…

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Clinical translation of stem cell therapy for spinal cord injury still premature: results from a single-arm meta-analysis based on 62 clinical trials...

IMAC Holdings, Inc. Announces Completion of Third Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the…

IMAC Holdings, Inc.

BRENTWOOD, Tenn., Sept. 09, 2022 (GLOBE NEWSWIRE) -- IMAC Holdings, Inc. (Nasdaq: BACK) (IMAC or the Company), today announces it has completed the third cohort of its Phase 1 clinical trial for its investigational compound utilizing umbilical cord-derived allogenic mesenchymal stem cells for the treatment of bradykinesia due to Parkinsons disease.

The third cohort consists of five patients with bradykinesia due to Parkinsons disease receiving an intravenous infusion of a high concentration stem cell treatment. The third and final cohort of the Phase 1 clinical trial was completed on Tuesday, September 6, 2022.

About IMACs Phase 1 Clinical Trial

The Phase 1 clinical trial, consisting of a 15-patient dose escalation safety and tolerability study, is being conducted at three of IMACs clinical centers in Chesterfield, Missouri, Paducah, Kentucky, and Brentwood, Tennessee. The trial is divided into three groups: 1) five patients with bradykinesia due to Parkinsons disease received a low concentration dose, intravenous infusion of stem cells, 2) five received a medium concentration intravenous dose, 3) and five received a high concentration intravenous dose. All groups will be subsequently tracked for 12 months. IMACs medical doctors and physical therapists at the clinical sites have been trained to administer the treatment and manage the therapy. Ricardo Knight, M.D., M.B.A., who is medical director of the IMAC Regeneration Center of Chicago, is the trials principal investigator.

The Institute of Regenerative and Cellular Medicine serves as the trials independent investigational review board, while Regenerative Outcomes provides management of the study. Further details of the trial can be found at clinicaltrials.gov.

About Bradykinesia Due to Parkinsons Disease

In addition to unusually slow movements and reflexes, bradykinesia may lead to limited ability to lift arms and legs, reduced facial expressions, rigid muscle tone, a shuffling walk, and difficulty with repetitive motion tasks, self-care, and daily activities. Parkinsons disease is the typical culprit of bradykinesia, and as it progresses through its stages, a persons ability to move and respond declines.

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According to Zion Market Research, the global Parkinsons disease therapeutics market was $2.61 billion in 2018 and is expected to grow to $5.28 billion by 2025. The Parkinsons Disease Foundation estimates that nearly 10 million people are suffering from Parkinsons disease, and almost 60,000 new cases are reported annually in the U.S.

About IMAC Holdings, Inc.

IMAC Holdingsowns and manages health and wellness centers that deliver sports medicine, orthopedic care, and restorative joint and tissue therapies for movement restricting pain and neurodegenerative diseases.IMACis comprised of three business segments: outpatient medical centers, The Back Space, and a clinical research division. With treatments to address both young and aging populations,IMAC Holdingsowns or manages outpatient medical clinics that deliver regenerative rehabilitation services as a minimally invasive approach to acute and chronic musculoskeletal and neurological health problems. IMACs The Back Company retail spinal health and wellness treatment centers deliver chiropractic care within Walmart locations. IMACs research division is currently conducting a Phase I clinical trial evaluating a mesenchymal stem cell therapy candidate for bradykinesia due to Parkinsons disease. For more information visitwww.imacholdings.com.

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Safe Harbor Statement

This press release contains forward-looking statements. These forward-looking statements, and terms such as anticipate, expect, believe, may, will, should or other comparable terms, are based largely on IMAC's expectations and are subject to a number of risks and uncertainties, certain of which are beyond IMAC's control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, risks and uncertainties associated with its ability to raise additional funding, its ability to maintain and grow its business, variability of operating results, its ability to maintain and enhance its brand, its development and introduction of new products and services, the successful integration of acquired companies, technologies and assets, marketing and other business development initiatives, competition in the industry, general government regulation, economic conditions, dependence on key personnel, the ability to attract, hire and retain personnel who possess the skills and experience necessary to meet customers requirements, and its ability to protect its intellectual property. IMAC encourages you to review other factors that may affect its future results in its registration statement and in its other filings with the Securities and Exchange Commission. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this press release will in fact occur.

IMAC Press Contact:

Laura Fristoe

lfristoe@imacrc.com

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IMAC Holdings, Inc. Announces Completion of Third Cohort of its Phase 1 Clinical Study of Umbilical Cord-Derived Mesenchymal Stem Cells for the...

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Top 3 grants in regenerative medicine: July 2022 - RegMedNet