American CryoStem Announces Patient Recruitment and Additional Sub-Investigator for its Post-Concussion Syndrome (PCS) Phase I Clinical Trial

Rhea-AI Summary

American CryoStem Corporation (OTC PINK:CRYO) has initiated patient recruitment for its IND Phase I Clinical Trial focused on post-concussion syndrome (PCS). The ATCELL™ trial will utilize autologous mesenchymal stem cell infusion therapy. Dr. Rand McClain joins the principal investigators as a sub-investigator. This trial addresses the substantial $48.3 billion annual cost of traumatic brain injuries in the U.S., with significant implications for healthcare. The clinical trial will be managed by BioSolutions Clinical Research Center in California.

Positive

• Commenced patient recruitment for IND Phase I Clinical Trial targeting post-concussion syndrome.
• Addition of experienced sub-investigator Dr. Rand McClain to the clinical trial team.
• Focus on an area with an estimated $48.3 billion annual healthcare cost in the U.S.

Negative

• None.

EATONTOWN, NJ / ACCESSWIRE / December 1, 2020 / 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 it has commenced recruiting subjects for its IND Phase I Clinical Trial and added an additional sub-investigator to the ATCELL™ Clinical Trial team.

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.

Dr. Rand McClain will join the previously announced Investigator team of Dr. Peter Hanson and Dr. Tal David (Principal Investigators) and Jason Baille, PhD, Dr. Rakhesh Guttikonda and Dr. Thomas C. Anderson III as sub-investigators.

Dr. McClain practices as part of Regenerative and Sports Medicine Clinic in Santa Monica, CA, an organization dedicated to advancing cellular treatments, procedures and research in the use of all available modalities to slow or reverse physiological effects of aging. Dr. McClain treats elite amateur, current and former professional athletes in almost all sports including the NBA, NFL, MLB, MLS, NHL, USTA and World Boxing organizations. He has participated in professional and elite amateur sports as an individual participant and as well as a member of two U.S. teams and continues to participate competitively. Dr. McClain has experience in assessing and treating athletes suffering from numerous types of sports related injuries including concussions. Dr. McClain has dedicated over 40 years of his personal and professional life studying nutrition, exercise, herbs and supplements in addition to medicine, and is also a Master of Traditional Chinese Medicine. He earned his medical degree at Western University and completed his internship at the University of Southern California's Keck School of Medicine Residency Program (USC California Hospital) and has worked with some of the best and original innovators in Sports, Regenerative, Cosmetic and Family Medicine.

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

Patient recruitment, screening and patient therapy will be 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.

Under the direction of Dr. Hanson and Dr. David, the sub-investigators will be responsible for assessing and screening applicants for participation and completing the ongoing assessment of each participant. These evaluations include patient physical and neuropsychological assessment testing and screening; preparation of source documentation and collection of assessment results; and assistance with completion of the final study reports and publications. The surgical tissue collection for ATCELL™, treatments and follow-up clinical visits will be conducted at BioSolutions Clinical Research Center facility in La Mesa, CA.

Interested participants should contact BioSolutions Research for additional information and to schedule an initial brief pre-screening call. Acceptable applicants will be contacted by BioSolutions to schedule a complete screening at their facility in La Mesa, California.

For further information please visit: www.americancryostem.com, send email to: info@americancryostem.com or contact the Company directly at 732-747-1007.

About American CryoStem
American CryoStem Corporation (OTC PINK: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 ATCELL Bank™ cryopreservation, the Company creates personalized adipose-derived mesenchymal stems cell infusion therapies and delivers successive multiple treatments of genetically matched cells as needed, on-demand for IV infusion or direct injection. American CryoStem dedicated to helping the world's physicians, hospitals, and clinics to 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 laboratory located in Monmouth Junction, New Jersey. The Company's proprietary end-to-end 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.

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

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FAQ

What is the purpose of the CRYO Phase I Clinical Trial?

The CRYO Phase I Clinical Trial aims to evaluate the safety and efficacy of autologous mesenchymal stem cell infusion therapy for treating post-concussion syndrome.

Who is leading the Phase I Clinical Trial for American CryoStem?

The trial is led by principal investigators Dr. Peter Hanson and Dr. Tal David, with Dr. Rand McClain as a sub-investigator.

Where is the CRYO clinical trial being conducted?

The CRYO clinical trial is being conducted at BioSolutions Clinical Research Center in La Mesa, California.

When did American CryoStem announce the start of patient recruitment?

American CryoStem announced the commencement of patient recruitment on December 1, 2020.

What is the financial impact of traumatic brain injuries in the U.S.?

The financial impact of traumatic brain injuries in the U.S. is estimated at $48.3 billion annually.