American CryoStem Enters into a Cooperative Research and Development Agreement (CRADA) to Develop Standardized Treatment Protocols

EATONTOWN, NJ / ACCESSWIRE / January 6, 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 entered into a Cooperative Research and Development Agreement (CRADA) authorized by published code 15 U.S.C. 3710a of US Title 15 Commerce and Trade. (https://www.disa.mil/about/cto/crada-process-overview) The Collaborative work will be conducted at the Biomedical Research Laboratory in Bethesda, Maryland.

The non-human research Collaboration entitled “Stem Cells for Regeneration and Medical Innovation” is a multi-faceted and multi-staged project centered on creating in vitro (test tube) assays to standardize and commercialize new treatment protocols; optimize quality control measures; and develop standardized protocol potency assays for precise therapy dosing. The Collaborative team plans to (a) validate and standardize baseline and assay metrics to identify mesenchymal stem cell (MSC) characteristics and quantities across various cell biomarkers and exosome expressions data sets from MSCs obtained from umbilical cord and adipose tissue, and to (b) investigate opportunities for testing protocol standardization for biologic drug development.  The Collaboration will further investigate the creation of predictive and prescriptive cellular models in support of future FDA biologic license applications. The Company maintains the rights to commercialize all technology developed under this CRADA Agreement and will endeavor to commercialize these technologies to create scientific and economic value for all stakeholders.

The Company’s long term research is focused on further developing standardized cellular processing models to support FDA, IND treatment protocol approvals by further identifying, and validating certain mechanisms and characteristics of mesenchymal stem cells related to regulating modulation of immune response(s) and promoting tissue regeneration and stability (homeostasis)  for the treatment of traumatic injuries, inflammation, auto-immune diseases, and brain and organ damage associated with viruses such as SARS-CO-V2 (COVID-19), including, the expanding group of people dealing with the chronic and debilitating symptoms of what is commonly termed “Long Haul COVID” or “Long COVID.”

“Our Collaboration ultimately aims to facilitate cell-based treatment protocol development toward personalized treatment; to improve the standard of care in large patient populations with serious health conditions; and patients who suffer from diseases with limited or no therapeutic options and unmet medical needs.” said CEO, John Arnone. “Our endpoints are focused on assessing treatment efficacy and clinical relevance to accelerate the creation and standardization of effective, clinical protocol development for multiple indications.  We are excited to take this first step as a lead-in to further collaborations with the US government”.

The cell-based assays market is projected to reach USD 18.9 billion by 2024 from USD 13.9 billion in 2019, at a CAGR of 6.3%. The growth of this market is majorly driven by the growing preference for cell-based assays, increasing research funding, and the growth in the number of drug discovery activities. However, the high cost of instruments and restrictions on reagent use are the major factors restraining the growth of this market.

American CryoStem believes that its standardized technologies provide the industry with much-needed protocols required to advance manufacturing capabilities and accelerate the development of cellular therapy applications. American CryoStem is utilizing its existing patented methods, protocols, technologies, cell lines, intellectual property portfolio and centralized laboratory model to support collaborative efforts for medical developments and innovation.

About CRADAs

A Cooperative Research and Development Agreement (CRADA) is a written agreement to optimize and maximize the use of resources, exchange technical expertise in a protected fashion, share intellectual property resulting from collaborative effort, and speed commercialization of developed technology.

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.

 REVISED FROM US. GOVT. PUBLIC AFFAIRS GUIDANCE

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