American CryoStem Announces Completion of Patient Recruitment for its Post-Concussion Syndrome (PCS) ATCELL(TM) Phase I Clinical Trial
EATONTOWN, NJ / ACCESSWIRE / December 22, 2021 / American CryoStem Corporation (OTC PINK:CRYO) a clinical-stage biotechnology company, global licensor, and a pioneer in autologous cellular processing and therapies announced today that its clinical study team has completed recruiting subjects for its Investigational New Drug (IND) Phase I Clinical Trial for Post-concussion syndrome. The singe site, multi-dosage blinded study is being conducted by BioSolutions Clinical Research Center, LLC.
The Principal Investigator (PI) today announced that the Study is 100% recruited; the Study team will begin administering the investigative ATCELL™ therapy treatments in January 2022. The Company's ATCELL™ (autologous mesenchymal stem cell) infusion therapy (the "Investigational New Drug") Study is titled: 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. The Study is listed on ClinicalTrials.gov under the identifier NCT04744051.
Recruitment and screening were performed at BioSolutions in La Mesa, CA, 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 clinical research, 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.
Principal Investigator, Peter Hanson, MD stated, "I would like to thank our team for all their hard work in successfully recruiting all participants for this study. In light of the recruitment difficulties many studies are experiencing during the pandemic, their dedication and effort has paid off. We look forward to begin participant treatments in the near future."
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 Corporation
American CryoStem Corporation: (CRYO), founded in 2008, is a clinical-stage biotechnology company, developing and delivering autologous mesenchymal stem cell (MSC) therapies utilizing its "mCMC" (mesenchymal, Chemistry, Manufacturing, and Controls) patented platform consisting of the "Collection-Processing-Cryobanking-Return to Point-of-Care of personalized therapy. The Platform supports a growing pipeline of biologic therapies, products, processes, and international licensing opportunities. The Company's patented platform provides the opportunity for a single adipose-tissue (fat) harvest to be processed, stored, and ultimately used for cosmetic fat transfer purposes or for immediate or future processing to MSCs. The platform is configured to produce large quantities of genetically matched mesenchymal stem cells (ATCELL) for future individual or successive treatments as needed, "on-demand". The Company has strategically positioned its cellular therapy product pipeline to; attract collaborative partners, accelerate creation of new treatment applications, and improve manufacturing processes and testing methods. Each new collaborative effort is designed to result in additional intellectual property and targeted commercial products to ultimately produce significant future revenue. CRYO is targeting topical applications and hard to treat neurologic diseases; disorders, and conditions that have a large unmet medical need and FDA Orphan Drug designation(s). The Company operates a cGMP compliant, FDA registered laboratory, located in Monmouth Junction, New Jersey, USA, with licensed laboratory operations in Hong Kong, China, and Thailand.
SOURCE: American CryoStem Corporation
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