American CryoStem Announces Patient Biomaterial Processing for its Post-Concussion Syndrome (PCS) Phase I Clinical Trial

Rhea-AI Summary

American CryoStem Corporation (OTC: CRYO) has initiated patient biomaterial processing for its FDA-approved IND Phase I Clinical Trial targeting Post-Concussion Syndrome (PCS)ATCell™. The company has successfully screened five participants, marking progress in addressing significant unmet medical needs associated with traumatic brain injuries, estimated to cost the U.S. $48.3 billion annually.

Positive

• Initiation of patient biomaterial processing for FDA-approved Phase I Clinical Trial.
• Successful screening of five participants for the trial.
• Focus on treating significant unmet medical needs related to PCS and traumatic brain injuries.

Negative

• None.

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

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 Corporation

American CryoStem Corporation (OTC: CRYO), is a clinical stage biotechnology company, global licensor and a pioneer in autologous 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 stem cell 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 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.

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 ATCell Phase I Clinical Trial by CRYO?

The trial aims to evaluate the effects of autologous mesenchymal stem cell therapy for treating Post-Concussion Syndrome in retired military and athletes.

When did American CryoStem start its Phase I Clinical Trial?

American CryoStem began processing patients' adipose tissue for the trial on March 11, 2021.

Who is conducting the patient therapy for the CRYO trial?

The patient recruitment and therapy are being carried out by BioSolutions Clinical Research Center, LLC in La Mesa, CA.

What are the estimated costs associated with traumatic brain injuries in the U.S.?

Traumatic brain injuries, including concussions, are estimated to cost the U.S. $48.3 billion annually.

What is the significance of the trial for American CryoStem's future?

The trial represents a potential milestone for CRYO in developing effective treatments for PCS, impacting future growth and market positioning.