FDA approves 2nd gene therapy cancer drug from Durham’s Precision Bio for clinical trial – WRAL Tech Wire

DURHAM Precision BioSciences, a genome-editing company based in Durham, has received authorization from the U.S. Food and Drug Administrationto advance its second genome-edited cancer therapy to clinical trials.

The FDA has accepted Precisions Investigational New Drug application for PBCAR20A to treat non-Hodgkin lymphoma (NHL), chronic lymphocytic leukemia (CCL), and small lymphocytic lymphoma (SSL).

Precisions technology is part of a new approach to fighting cancer using T cells a type of immune system cell that recognizes invading germs or cancer cells. T cells are engineered to carry a cancer bullet called a tumor-targetingchimericantigenreceptor (CAR). These engineered cells have the potential to save the lives of many patients unresponsive to traditional chemotherapy and radiation regimens.

Precision Biosciences

Autologous CAR T therapies currently on the market rely on patient-derived T cells, which are extracted and individually manufactured for each patient using that patients own cells. They require a complex and lengthy process.

Precisions allogeneic CAR T product candidates use T cells derived from qualified donors. The T cells are manufactured in large batches and are cryopreserved (safely preserved, intact, at extremely low temperatures) for shipment, storage and off-the-shelf use.

These allogeneic CAR T product candidates rely on Precisions ARCUS genome-editing platform to remove the T cell receptor to prevent graft versus host disease without the need for donor-patient matching. ARCUS editing also enables targeted insertion of the CAR gene into a single, specific location in the T cell genome for more controlled, consistent expression.

Pfizers 300 new jobs, $500M investment symbolize Triangles growth as gene therapy hub

The company said it will begin a Phase1/2a clinical trial later this year in non-Hodgkin lymphoma patients, including a subset of patients with a cancer called mantle cell lymphoma, for which Precision has received the FDAs Orphan Drug designation.

PBCAR20A is Precisions second off-the-shelf cell therapy. The company is also studying the precursor to PBCAR20A PBCAR0191 in adult patients who are not responding to other therapies. Technically, these are designated as patients with relapsed or refractory (R/R) NHL or R/R B-cell precursor acute lymphoblastic leukemia (B-ALL).

Both of Precisions treatments use the companys ARCUS genome editing technology to produce CAR T cells derived from healthy donors, rather than relying on cancer patients own blood. The development of these allogeneic CAR Ts is designed to overcome the manufacturing limitations of traditional autologous CAR T therapies, to target a broader range of malignancies, and to increase the number of patients who can potentially benefit.

FDA clearance to begin clinical trials with our anti-CD20 off-the-shelf therapy candidate is a significant milestone for Precision, said Matt Kane, the companys CEO and co-founder. Todays announcement demonstrates our ability to advance multiple product candidates in parallel into the clinic, leveraging the unique capabilities of our ARCUS genome editing platform, CAR T development approach and highly differentiated manufacturing process developed in-house.

Precision uses ARCUS to remove T cell receptors to prevent graft versus host disease, thus avoiding the need for donor-patient matching that is required in traditional tissue donation procedures. And the ARCUS technology also provides for the targeted insertion of the CAR gene into a single, specific location in the T cell genome for controlled, consistent expression. Precisions product candidates can be made in advance, manufactured in large batches and then cryopreserved for shipment, storage and off-the-shelf use.

AskBio gets $235 million in gene therapy support

PBCAR20A, if approved, will fill an important gap in current cancer treatments. In the United States, B-cell malignancies account for 85 percent of all non-Hodgkin lymphoma. And CLL and SLL represent 25 to 30 percent of leukemia cases. Precision said that, while front-line treatments benefit more than half of newly diagnosed NHL patients, at least a third of those achieve only partial remission or relapse after remission.And patients with CLL have limited success with autologous CAR T therapies. An allogeneic CAR T like PBCAR20A may overcome treatment resistance and offer the possibility of combination treatments.

It is our hope that PBCAR20A will provide a new allogeneic CAR T therapy option with the benefits of reliable, off-the-shelf access and optimized cellular activity to patients living with NHL or CLL/SLL, where a significant need for new treatment options remains, said David Thomson, Precisions chief development officer.

Precision Biosciences is a 2006 Duke University spin-out dedicated to improving life by using its ARCUS gene editing technology to treat human diseases and create healthy and sustainable food and agriculture solutions.

In 2018 the company created a new name and brand identity for its food and agriculture business,Elo Life Systems. The business is using Precisions ARCUS platform and other new technologies for applications in crop improvement, animal genetics, industrial biotechnology and sustainable agriculture.

(C) N.C. Biotech Center

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FDA approves 2nd gene therapy cancer drug from Durham's Precision Bio for clinical trial - WRAL Tech Wire

Michael Schumacher ‘Conscious’ After Undergoing Stem Cell Therapy in Paris – News18

The stricken seven-time Formula One world champion Michael Schumacher has undergone cell therapy surgery in Paris' Georges-Pompidou hospital and is now "conscious", according to French daily Le Parisien.

According to the daily, Schumacher was in the cardiovascular department overseen by surgeon Philippe Menasche, described as a 'pioneer in cell surgery against heart failure'.

The German received stem cells to obtain an anti-inflammatory effect throughout his system, Le Parisien suggested.

While there has been no official statement from Schumacher's entourage, Le Parisien quoted an unnamed nurse at the hospital regarding the Formule One legend's situation.

"Yes he is in my service," the nurse was quoted as saying. "And I can assure you that he is conscious."

The athlete was struck down by a skiing accident that snapped his helmet in December 2013 and little information on his condition has been made public since then.

He was placed in a medically-induced coma for six months after the fall and was moved from Grenoble hospital to Lausanne before being returned home in September 2014 where he receives private treatment.

It has been suggested by old friends he is unable to walk or properly communicate.

Schumacher won his first world title 25 years ago and had won his first Grand Prix back in 1992. His glory years were spent at Benetton and Ferrari, for whom he won the last of his 91 Grand Prix victories in China in 2006.

He came out of retirement in 2010 for a three-year stint with Mercedes. Fans revere the determined German and his name was chanted at the Monza circuit last weekend for Ferrari's most successful Formula One driver Schumacher, with his son Mick, who is part of the Ferrari Driver Academy, present.

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Michael Schumacher 'Conscious' After Undergoing Stem Cell Therapy in Paris - News18

Stem Cell Therapy for Lower Back Pain Moves Closer – Pain News Network

What does this mean? First and foremost, its great news for people suffering from back pain. This is a population that is woefully underserved by conventional medicine. Limited options include analgesics like opioids, which are increasingly difficult to obtain, and spinal surgery that is costly, often ineffective and can even exacerbate the problem. I have previously written about these issues here.

Clinicians around the country have been using stem cell therapy (SCT) for years to treat back pain and even difficult spinal conditions like arachnoiditis. However, these clinics have been operating under the scythe of potential persecution for using products not approved by the FDA.

Not only has this placed them squarely in the crosshairs of regulatory authorities which issue warning letters and file lawsuits, but it has also subjected them to internet censorship by Google and others.

The Mesoblast-Grunenthal partnership is indicative of the fact that major corporate investment in SCT is increasing -- and that can be a great thing for consumer choice. More and more biotech investors are recognizing that SCT is the future of medicine, especially when it comes to treating conditions caused by chronic inflammation. Forbes reports that the market size of the SCT industry was $8.65 billion in 2018, with a projected annual growth rate of 8.8%.

We saw recent evidence of this trend with Bayers acquisition of Bluerock Therapeutics and its stem cell treatments for Parkinsons disease and other chronic illnesses. And Boston-based Vertex Pharmaceuticals recently acquired Semma Therapeutics for $950 million in a bet that its SCT products could cure type 1 diabetes.

Why is the SCT market so robust? Transparency Market Research attributes it to a rise in consumer awareness. In other words, people are desperate for relief and looking for new treatments. Suffice it to say, any additional treatment option for those suffering from back pain is more than welcome.

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Stem Cell Therapy for Lower Back Pain Moves Closer - Pain News Network

ECTRIMS: Atara’s off-the-shelf T cells for EBV-driven MS show promise in small study – FierceBiotech

Epstein-Barr virus (EBV) is thought to play a role in the development of some diseases, including multiple sclerosis. San Francisco-based Atara Biotherapeutics has been developing a cell therapy for MS that targets the virus, and it has results from a phase 1 study that its executives believe provide strong justification for larger studies of the approach.

The therapy, called AT188, is made of T cells that target and attack EBV-infected B cells. In the phase 1 trial, all six of the patients who received the highest of the two doses reported showed at least a partial improvement in MS symptoms at six months, while four of the six patients on the smaller dose showed a clinical decline. The company discussed the results at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).

Epstein-Barr is known to increase the risk of MS, and the virus has been found in the brains of patients with the disease at higher rates than it has in healthy people.

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Atara is developing two T-cell therapies that target EBV: ATA190, which is autologous, or derived from individual patients own immune cells; and ATA188, which is allogeneic, meaning it can be premanufactured from unrelated donor cells. The company is launching a phase 2 study of ATA190 this year and said at ECTRIMS that it has completed enrollment in the phase 1 trial of ATA188.

RELATED: Anti-cancer immune cells protect against MS in mice

T-cell therapies have so far made the biggest impact in oncology, with the FDA approvals of two treatments for blood cancer, Novartis Kymriah and Gilead Sciences' Yescarta. Both products are personalized in a complex process that involves removing T cells from patients and engineering them to be able to recognize and attack their cancers. The success of those treatments has inspired research aimed at applying the technology to other diseasesand simplifying it by developing off-the-shelf cells.

The early ATA188 trial was primarily designed to establish a safe dose of the cells in MS, but Atara also measured efficacy based on seven criteria including fatigue, visual acuity and walking ability. Atara hopes to show that its T-cell therapies can improve upon existing MS drugs, which suppress the out-of-control B cells that cause the diseases disabling symptoms. Those drugs can slow the progression of MS, but they havent been shown to reverse its symptoms, Atara CEO Pascal Touchon said during a conference call with analysts after the presentation.

While the immunosuppressive approaches may help to address some of the molecular and cellular dysfunctions that give rise to MS symptoms, they might not directly target the underlying pathogenesis of the disease, Touchon said. Therefore is a need for new approaches that have the potential to stop or even reverse disease progression, he added. Touchon headed up Novartis' oncology efforts before jumping ship to become CEO of Atara in May.

During the call, one analyst asked whether there were any differences between the two patient groups that could explain the results, aside from the dosage of cells each received. There were no demographic differences or other factors that would have caused the patients on the higher dose to respond better, said AJ Joshi, M.D., chief medical officer of Atara.

Another analyst wondered whether ultimately the company would investigate even higher doses than whats planned for this phase 1 study. The trial would need to show a directly correlation between increasing the quantity of cells and an improvement in symptoms, Joshi said. Wed really want a good reason to move higher on the dosing.

When asked whether the company is using imaging technology to track the cells in the brain, Joshi said that would happen in larger, placebo-controlled studies. Atara plans to report detailed data from the phase 1 study next year and to identify the dose for a randomized, double-blind, placebo-controlled phase 1b study.

Amit Bar-Or, M.D., chief of the Perelman School of Medicine's MS division at the University of Pennsylvania, said in a statement that the early findings from Atara look promising. The outcome classification using multiple clinically recognized MS scales is an innovative approach, and I look forward to advancing the study alongside my colleagues for progressive MS patients who have limited treatment options and where continual clinical decline is expected.

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PPF Expands its Investment in the Healthcare Sector Through Acquisition of Significant Stake in T Cell Therapy Company Autolus Therapeutics – b3c…

PRAGUE, Czech Republic, September 16, 2019 / B3C newswire / -- PPF today announces the acquisition of a 19.2% stake in Autolus Therapeutics plc, a leader in next-generation T cell programming technologies. The shares were acquired in the market through NASDAQ.

Autolus Therapeutics plc (Autolus) is a leader in T cell programming technologies and is developing a pipeline of next generation T cell therapies targeting both hematological cancers and solid tumors. Focused on the development of precisely targeted, controlled and highly active CAR-T cell products, Autolus aims to provide T cell therapies with very favorable safety profile and enhanced clinical efficacy to better recognize cancer cells, break down their defense mechanisms, and attack and kill these cells. The lead program AUTO1 is expected to enter a pivotal phase II study in patients with adult relapsed or refractory acute B lymphocytic leukemia (adult ALL) later this year with an anticipated filing for marketing authorization in 2021.

With the investment into Autolus, PPF Group N.V. (PPF) significantly increased its commitment to the healthcare sector. Next to Autolus, PPFs majority-owned biotechnology company SOTIO a.s. (SOTIO) is aiming to become a fully-integrated oncology specialty pharma company. Together with SOTIO, PPF have built a biotechnology portfolio through in-house research and development, investments, acquisitions and in licensing of products with companies like NBE-Therapeutics, Cellestia Biotech, Cytune Pharma or Lead Discovery Center. SOTIO is developing its proprietary dendritic cell-based cell therapy platform DCVAC and has a significant manufacturing and regulatory expertise in the domain of cellular therapies. SOTIO also recently initiated a Phase I/Ib clinical trial with its interleukin-15 superagonist SO-C101.

We are very excited by our investment into Autolus. The data published by Autolus on their CAR-T programs is very promising and their long-term ambitions are a perfect match with PPFs strategy in healthcare, said Ladislav Bartonicek, shareholder of PPF responsible for the biotechnology sector. Our investment in Autolus confirms the long term commitment of PPF and SOTIO to build a strong biotechnology portfolio developing a broad range of its own oncology products and investing in various biotech companies with promising new therapies.

About PPF PPF invests in multiple market segments such as banking and financial services, telecommunications, real estate, mechanical engineering, biotechnology, and insurance. PPF Groups reach spans from Europe to the USA and across Asia, owning assets worth over EUR 45 billion (as at 31 December 2018).As at 31 December 2018, PPF Group employed 158,000 people globally, while its companies based in the Czech Republic employed almost 14,000.

About SOTIOSOTIO is an international biotechnology company leading the efforts of PPF Group to build a diverse biotechnology portfolio through its own research & development, collaborations, in-licensing, investments, mergers and acquisitions. The company is developing new medical therapies, focusing on the treatment of cancer and autoimmune diseases. The most advanced project is the SOTIO proprietary platform of active cellular immunotherapy (ACI) based on dendritic cells. SOTIO is conducting multiple Phase I to Phase III clinical trials verifying the safety and efficacy of its DCVAC products. SOTIO is also collaborating with NBE-Therapeutics on the development of novel antibody-drug conjugate products (ADC), with Cytune Pharma on developing novel IL15-based immunotherapies for the treatment of cancer and with LDC and the Max Planck Society on an oncology program addressing a novel target in tumor metabolism. SOTIO has facilities in Europe, the United States, China and Russia. SOTIO is a registered trademark of SOTIO a.s. in selected countries.

Contacts

Jitka TkadlecovSpokeswoman for PPF GroupT +420224174410M +420725 461 574This email address is being protected from spambots. You need JavaScript enabled to view it.www.ppf.eu

Richard KapsaHead of Communication for SOTIOT +420224174448M +420603 280 971This email address is being protected from spambots. You need JavaScript enabled to view it. http://www.sotio.com

Published by B3C newswire and shared through Newronic

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PPF Expands its Investment in the Healthcare Sector Through Acquisition of Significant Stake in T Cell Therapy Company Autolus Therapeutics - b3c...

Unproven stem cell treatments provide expensive last resort in families’ search for hope – ABC News

Updated September 18, 2019 06:37:06

It is a quiet Monday morning, and as people are returning to desks and lining up for coffee, Doreen Deede is zig-zagging between bars, collecting cans and bottles emptied over the weekend.

Cashing in refundable containers, hosting charity events, even selling donuts at a local market Ms Deede tried all options as she inched towards a fundraising goal of $35,000 to fund overseas medical treatment.

"For the past nine years I've been Emma's sole carer," she said.

"I call myself her fundraising manager because that's what I've been doing."

Emma, aged nine, suffered a brain injury at birth and has been living with cerebral palsy and dystonia a condition where her muscles contract uncontrollably.

Ms Deede's social life all but vanished as her daughter grew up and significant problems with her mobility, eating, and speech began to register.

"That's when I decided that I wanted to be a mum that gives everything to my daughter," she said.

"The choice included that I live for her, that I do everything in my power to give her all the chances that she can get to one day live independently."

This week, the small family will take another of those chances when they travel from Cairns to the United States for a stem cell treatment to be administered to Emma via two lumbar punctures.

Even with Ms Deede's exhaustive fundraising regime the procedure is so expensive she has had to take out a bank loan and then there is the fact that the procedure has not been clinically proven.

"Everyone that is a parent will know that you do everything for your child," Ms Deede said.

"I would feel guilty if I don't try."

In Australia, the only stem cell treatments classed by the Therapeutic Goods Administration as safe and effective have a narrow application. They generally involve the use of umbilical cord blood or bone marrow to treat disorders of the blood or immune system.

These treatments rely on the function of stem cells, which are unallocated, to replace cells that may be lost or damaged.

Also seizing on that potential has been a burgeoning market of private clinics offering solutions to disorders broadly ranging from neurological conditions to ageing.

As the deputy director of the University of Melbourne's Centre for Stem Cell Systems, part of Megan Munsie's job has been to help inquisitive families understand the sometimes significant gap between what these clinics offered and what was actually sold.

"One of my biggest challenges in this field is the fact that stem cells are somehow seen as magical," she said.

"It's an example of non-evidence-based practice that's gone mainstream."

Ten years ago, this practice sometimes termed stem cell tourism was confined to a handful of clinics in exotic locations.

Since then Dr Munsie has witnessed growth in the number of clinics offering these treatments around the world.

In some cases, they may have been supported only by effusive patient testimonies or materials that blurred the line between medical science and marketing sometimes at the expense of communicating that these procedures were invasive and potentially harmful.

"Our responsibility as a research community is to try to contextualise the science and paint a clearer picture about where exactly we are," Dr Munsie said.

"Unfortunately that means that most of those conversations start with a disclaimer that we don't have any proven treatments for that condition."

On the other side of the equation were families like Ms Deede's, buoyed by hope and leaving no stone unturned.

Success stories may add to the guilt some parents feel.

Even in Cairns, another local family has credited two rounds of treatment with helping their son, who also lives with cerebral palsy, learn to speak and improve his fine motor skills.

"What we do know is there's certainly a lot of promise in this area, but we do still need more data to answer some of the many questions that remain," said Megan Finch-Edmondson, a stem cell researcher with the Cerebral Palsy Alliance Research Institute.

"It's a very interesting and complex question."

Like Dr Munsie, Dr Finch-Edmondson has been in frequent contact with families keen to explore their options.

An Australian-first trial conducted by Melbourne's Murdoch Children's Research Institute has been investigating the use of umbilical cord blood to treat cerebral palsy.

Even though it was only a trial and the selection criteria was rigorous, the limited spaces were highly coveted.

"That is one of the reasons that we are so committed to trying to progress this research and conduct more rigorous clinical trials in Australia," Dr Finch-Edmondson said.

"We do need to operate within [rigorous regulatory guidelines] to get any new therapy, or treatment that's like a drug, approved for use in Australia.

"It does require those very rigorous trials that can show enough data to those regulatory bodies to warrant that this treatment should be available."

Until then, families hamstrung between a long regulatory process and the promises of unproven treatments may continue to take the leap.

"I'm doing it because I love my daughter and I want to give her the best life and the best chance of improvement," Ms Deede said.

"I don't want to be in a situation where I haven't done everything I could and in 10 years' time I might be thinking 'What if?'."

Topics:medical-sciences,health-policy,medical-procedures,healthcare-facilities,medical-research,cerebral-palsy,stem-cells,cairns-4870,university-of-melbourne-3010,melbourne-3000,united-states

First posted September 18, 2019 06:34:23

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Unproven stem cell treatments provide expensive last resort in families' search for hope - ABC News

American CryoStem Announces: FDA Accepted its Investigational New Drug Application for Post Concussion Syndrome – Yahoo Finance

ATCell Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Military and Athletes

EATONTOWN, NJ / ACCESSWIRE / September 18, 2019 / American CryoStem Corporation (OTC PINK:CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular products and technologies for the Regenerative and Personalized Medicine industries, announced today that it has submitted its first Investigational New Drug Application application for its ATCell product (the "Investigational Drug"), to the U.S. Food and Drug Administration (FDA).

The FDA's acceptance for review of American CryoStem's IND application is a significant milestone for the Company and represents a meaningful step forward in the treatment of patients suffering from Post Concussion Syndrome ("PCS"), and for the advancement of Regenerative Medicine. We are now one step closer to obtaining approval to treat patients with a cellular therapy derived from the patient's own adipose tissue. ATCell, autologous adipose-derived mesenchymal stem cells, is positioned to be a valid therapeutic modality to treat PCS, offering a cellular therapy option to patients not responding to the current standard of medical care.

ATCell is a stem cell product derived from the patient's adipose tissue with biomarker identification through flow cytometry consistently in excess of 97% and is genetically matched to its recipient. The Company's scalable, centralized laboratory model and patented Collect-Process-Store-Return to Point-of-Care Foundational Platform is a best in class end-to-end solution for cellular therapy development and treatment delivery. Through a single adipose-tissue harvest, the Company's laboratory model can create multiple cellular treatments to address various indications and deliver multiple treatments of the patients own genetically matched cells over time affording clinicians the opportunity to pre-plan treatments for their patients.

ATCell samples have been designed to be delivered to physicians, "on demand and ready to use" without complicated and time consuming preparation at the point-of care. Access to the Company's end-to-end, cGMP centralized laboratory processing model and standardized cell manufacturing platform allows physicians, researchers, and collaborators the opportunity to develop new cellular applications and products without the expense of operating a GNP laboratory. This methodology can reduce the development delays and requirements to re-discover and re-create the necessary processing technology (Collect-Process-Store) necessary for the development of new therapies for each specific medical indication.

The Company's Phase I Clinical Trial, upon FDA approval, will investigate ATCell to provide assessments of the safety and tolerability, and to collect clinical data regarding the alleviation of symptoms associated with Post-Concussion Syndrome (IDC-10-CM:F07.81).

Following initiation of the Trial, the Company intends to make ATCell available to collaborators and partners for the development of additional treatment protocols for neurological disorders, muscle-skeletal disease and injury, and tissue repair, among others. Strategically, by rapidly seeking and obtaining approved uses of ATCell, the Company can position itself to become a leader in the development and delivery of treatments into global cellular therapy markets.

Using ATCell, with its high cellular purity and cellular consistency can be an effective treatment of diseases and conditions where there is significant unmet medical need, such as Post Concussion Syndrome. The data generated from this initial study will be used in support of the Company's ongoing efforts to secure regulatory approvals for its patented product for a wide range of medical indications domestically and through its licensed affiliates in China, Japan, Hong Kong and Thailand.

The Phase I Clinical Trial study is designed as a single-site, double-blinded, placebo-controlled study. Each subject will receive either a single infusion of their ATCells or a placebo. Each ATCell cell line will be created from adipose tissue collected by liposuction, and each treated subject will only receive their own cells.

Story continues

Following successful recruitment, each subject will be required to undergo a mini liposuction procedure to obtain the raw material- adipose tissue (AT) for processing, testing and preparation of their autologous treatment. Following administration, each subject participant will be followed for six months for evaluation and safety monitoring at designated intervals of one day, one week, and one, three and six months.

ATCell is defined as expanded autologous adipose-derived mesenchymal stem cells having the following identification through flow cytometry analysis:

1. Positive expression of the phenotypic marker antigens CD13, CD29, and CD44

2. Negative expression of the phenotypic marker antigens CD31, CD34, and CD45

During development of the ATCell treatment product, the Company will confirm that these cells are plastic adherent and capable of tri-lineage differentiation.

Post-Concussion Syndrome (PCS) is a set of symptoms that may continue for weeks, months, a year or more after a concussion. Any individual with a history of even a single concussion may develop persistent symptoms associated with the injury.

Overall, the estimated cost of traumatic brain injuries (TBI) in the United States weighs in at $48.3 billion annually of that $31.7 billion is spent on hospitalization costs, while the additional $16.6 billion is attributed to costs associated with fatalities. According to the Center for Disease Control, acute care and rehabilitation of brain injury patients in the United States cost about $9 - $10 billion per year. This does not include indirect costs to society, and families, associated with lost earnings, work time, and productivity, as well as expenditures linked to social services. https://www.brainandspinalcord.org/cost-traumatic-brain-injury/.

The Company recognizes the significant market opportunity for its new autologous cellular therapy modality for the treatment of Post Concussion Syndrome and mild Traumatic Brain Injury via infusion therapy of Autologous Expanded Adipose-Derived Mesenchymal Cells. The Company intends to leverage its early clinical study using this delivery protocol for the treatment of other diseases and muscle-skeletal disease and injuries with significant multibillion dollar therapy markets.

CRYO's GMP laboratory platform serves to accelerate physician and patient adoption of cellular therapeutics as new and effective treatment protocols. Stringent manufacturing protocols include triple sterility checks, high cell viability, potency and proliferation manufacturing is unmatched in the industry.

American CryoStem is looking forward to harnessing the power of its autologous stem cell platform technology to transform the lives of people with substantial serious diseases and address unmet medical needs around the world.

For further detailed Corporate or Regenerative Medicine information please visit:www.americancryostem.com, request by email at info@americancryostem.com or

phone 732-747-1007

This press release may contain forward-looking statements, including information about management's view of American CryoStem Corporation's ("the Company") future expectations, plans and prospects. In particular, when used in the preceding discussion, the words "believes," "expects," "intends," "plans," "anticipates," or "may," and similar conditional expressions are intended to identify forward-looking statements. Any statements made in this press release other than those of historical fact, about an action, event or development, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors, which may cause the results of the Company, its subsidiaries and concepts to be materially different than those expressed or implied in such statements. Unknown or unpredictable factors also could have material adverse effects on the Company's future results. The forward-looking statements included in this press release are made only as of the date hereof. The Company cannot guarantee future results, levels of activity, performance or achievements. Accordingly, you should not place undue reliance on these forward-looking statements. Finally, the Company undertakes no obligation to update these statements after the date of this release, except as required by law, and also takes no obligation to update or correct information prepared by third parties that are not paid for by American CryoStem Corporation.

SOURCE: American CryoStem Corporation

View source version on accesswire.com: https://www.accesswire.com/560118/American-CryoStem-Announces-FDA-Accepted-its-Investigational-New-Drug-Application-for-Post-Concussion-Syndrome

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American CryoStem Announces: FDA Accepted its Investigational New Drug Application for Post Concussion Syndrome - Yahoo Finance