EATONTOWN, NJ / ACCESSWIRE / March 11, 2021 American CryoStem Corporation (OTC: CRYO) a clinical stage biotechnology company, global licensor and a pioneer in autologous cellular processing and therapies announced today that it has begun processing patient's adipose tissue and culturing mesenchymal stem cells (ATCell™), for use in its FDA approved IND Phase I Clinical Trial.
The Company's autologous mesenchymal stem cell infusion therapy ("Investigational Drug") development is part of a single center study under the protocol entitled: 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. Patient recruitment, screening and patient therapy is being performed by BioSolutions Clinical Research Center, LLC. ("BioSolutions") located in La Mesa, CA. BioSolutions is dedicated to clinical research with over 25 years of collective experience in the fields of medicine and clinical trials from orthopedics to stem cell therapies. BioSolutions is comprised of community-based investigators dedicated to overseeing all aspects of clinical trials with an experienced team of clinical research professionals focusing on quality research data while recognizing that speed, responsiveness and accountability are also core needs. The surgical tissue collection for ATCELL™, treatments and follow-up clinical visits is being conducted under the direction of Dr. Peter Hanson, principal investigator.
Anthony Dudzinski, COO, stated, "To date, five participants have completed the screening process within our extensive inclusion/exclusion criteria. The initial acquisition of their adipose tissue and cell culturing has begun. We believe that our first of kind cellular therapy study focuses on the effects of post-concussion syndrome resulting from traumatic brain injuries will set the industry standard for the long-term treatment of patients suffering from unmet medical needs".
Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States, including concussion injuries, weighs in at $48.3 billion annually of which $31.7 billion is spent on hospitalization costs; an additional $16.6 billion is associated with costs attributed to fatalities. According to the Centers for Disease Control, acute care and rehabilitation of brain injury patients in the United States costs about $9 billion to $10 billion per year. This does not include indirect costs to society and family caretakers due to lost productivity, work time and earnings, as well as costs linked to providing social services. https://www.brainandspinalcord.org/cost-traumatic-brain-injury
About American CryoStem
American CryoStem Corporation (OTC:CRYO), is a clinical stage biotechnology company, global licensor and a pioneer in autologous (one’s own) cellular processing and therapies. The Company's centralized laboratory model and patented foundational “CryoStem Platform” is a best-in-class, end-to-end cellular therapy solution to treat injuries, disorders and chronic diseases through a single adipose-tissue (fat) harvest and ATCELLBank™ cryopreservation. The Company creates personalized adipose-derived mesenchymal stems cell infusion therapies and delivers successive multiple treatments of genetically matched cells as needed. American CryoStem is dedicated to helping the world’s physicians, hospitals, and clinics improve clinical outcomes by developing and delivering effective leading-edge stem cell therapies that improve patient health and quality of life. The Company's maintains an FDA registered cGMP compliant laboratory located in Monmouth Junction, New Jersey. The Company’s proprietary end-to-end centralized laboratory Adipose Tissue Processing Platform consists of the “Collection – Processing – Cryobanking – “Return to Point-of-Care”/ On Demand, of adipose tissue and adipose-derived mesenchymal stems cells.
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SOURCE: American CryoStem Corporation