American CryoStem Announces: FDA Accepted its Investigational New Drug Application for Post Concussion Syndrome
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.
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:
- Positive expression of the phenotypic marker antigens CD13, CD29, and CD44
- 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.