American CryoStem Completes Clinical Protocol Design for Long COVID Study
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EATONTOWN, NJ / ACCESSWIRE / November 30, 2021 / American CryoStem Corporation (OTC PINK:CRYO), a leading clinical-stage biotechnology developer of adipose-derived stem cell therapies today announced completion of its Phase I clinical protocol design for the treatment of Long COVID. American CryoStem anticipates that the protocol will be filed as an FDA Phase I IND in cooperation with a major US medical center in Q-1, 2022.
Medical complications of Long Covid patients include reports of the development of new or recurrent symptoms that affect several distinct physiologic systems including but not limited to neurological, respiratory, gastrointestinal, cardiac, endocrine, dermatological, hepatic, and renal that persist for many months following resolution of the acute infection and associated illness.
According to the Centers for Disease Control and Prevention, "post-COVID conditions can be considered a lack of return to a usual state of health following acute COVID-19 illness." In the US, following COVID recovery, it is reported that up to 30% of those afflicted, diagnosed, or treated for COVID-19 have continuing symptoms and medical complications following recovery from the acute illness. A recently published study of patients diagnosed with COVID-19 suggest that the global incidence of Long Covid complications may be much higher. See: Incidence, co-occurrence, and evolution of long-COVID features: A 6-month retrospective cohort study of 273,618 survivors of COVID-19
The Company continues to collaborate with its scientific and clinical teams to file the Investigational New Drug (IND) application with its institutional partner to facilitate the timely initiation of its Phase I clinical testing. American CryoStem is focused on developing effective stem cell therapies to treat and ameliorate Long COVID. The upcoming Phase I clinical trial will assess CryoStem's proprietary ATCell® therapy for safety and tolerability in the setting of Long COVID with the goal of rapidly developing a safe and effective therapy for Long COVID, where none currently exists.
About American CryoStem Corporation: (CRYO), founded in 2008, is a clinical-stage biotechnology Company, developing and delivering autologous mesenchymal stem cell (MSC) therapies leveraging its mCMC (mesenchymal, Chemistry, Manufacturing, and Controls) patented platform to collect-process-store-return to point of care genetically matched personalized therapy. The Platform supports a growing pipeline of biologic therapies, products, processes, and international licensing opportunities. The Company's platform provides patients 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 (ATCellÂ®) for future individual or successive multiple 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. New collaborative efforts are designed to result in additional intellectual property and targeted commercial products to ultimately produce significant future revenue. CRYO is targeting topical applications and untreatable and incurable neurologic diseases, disorders, and conditions that have a large unmet medical need and US FDA Orphan drug designation. The Company operates a cGMP compliant, FDA registered laboratory, located in Monmouth Junction, New Jersey, USA, and licensed laboratory operations in Hong Kong, China, and Thailand.
SOURCE: American CryoStem Corporation
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