American CryoStem Announces: FDA has cleared its Investigational New Drug (IND) for Post-Concussion Syndrome for Phase I Clinical Trial

EATONTOWN, NJ / ACCESSWIRE / September 23, 2020 / American CryoStem Corporation (OTC PINK:CRYO) is a clinical stage biotechnology company, global licensor, and a pioneer in autologous cellular therapy processing. The Company has developed proprietary products and services to advance its end-to-end personalized cellular therapy platform consisting of the collection - processing - cryobanking - return to point-of-care of adipose tissue and adipose-derived mesenchymal stems cells.

The Company announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for Phase I, to develop ATCell™, a proprietary expanded autologous adipose-derived mesenchymal stem cell therapy for the treatment of Post-Concussion Syndrome (PCS). PCS is a complex disorder triggered by one or more concussive injuries. The IND will enable CRYO to proceed in the 4th quarter of 2020, with its Phase I clinical trial designed to evaluate the safety and efficacy of ATCell™. ATCell™ is positioned to be a valid therapeutic modality to treat PCS, offering a cellular therapy option to patients not responding to the current standard of medical care.

"The clearance of this IND represents an important milestone for American CryoStem and millions of Americans including athletes and military personnel suffering from Post-Concussion Syndrome who have limited treatment options and significant unmet medical needs," stated John Arnone, Chairman and Chief Executive Officer of CRYO. "Our goal is to develop a new approach to a common central nervous system disorder with the potential to alter treatment protocols. We are very excited about investigating the efficacy of ATCell™ for Post-concussion syndrome (PCS). Topline data from our Phase I study will be available in 2021."

The planned randomized, double-blind, placebo-controlled Phase I clinical trial 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." Retired athletes and military service members with confirmed diagnosis of PCS from three or more concussion or mild traumatic brain injuries (mTBI) resulting in symptoms that are persistent and unresolved at least three months following the latest injury will be recruited. PCS symptoms include headaches, fatigue, depression, anxiety and irritability, as well as impaired cognitive function that can be permanent. The study will enroll 20 patients with military or sports-related PCS diagnosis in four groups. Participants will be randomized, and three groups will receive a treatment of their own cells administered in a single treatment at the dosing levels of (50 million cells, 150 million cells, 300 million cells) through intravenous infusion. The fourth group, the control group will receive an infusion of placebo. The primary analysis will compare differences in changes to mean scores using clinician-administered questionnaires commonly used to diagnose PCS.

Anthony Dudzinski, COO stated, "In general, mild TBI events need to be taken far more seriously. Even mild TBI events can result in lasting negative and cognitive consequences as evidenced by lower performance on neuropsychological assessments of patients diagnosed with PCS. In fact, this disorder has been theorized to eventually lead to PTSD, Alzheimer's Disease (AD) as well as Chronic traumatic encephalopathy (CTE). The importance of this opportunity to physically treat sufferers of PCS cannot be understated, especially for our military service members."

Overall, it is estimated that the cost of traumatic brain injuries (TBI) in the United States 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 Center 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.

About ATCell
ATCell™ is a stem cell product derived from the patient's adipose tissue with biomarker identification through flow cytometry consistently in excess of 97% and is genetically matched to its recipient. The Company's scalable, centralized laboratory model and patented Collect-Process-Store-Return to Point-of-Care Foundational Platform is a best in class end-to-end solution for cellular therapy development and treatment delivery. Through a single adipose-tissue harvest, the Company's laboratory model creates multiple cellular treatments to address various indications and deliver multiple treatments of the patient's own genetically matched cells over time affording clinicians the opportunity to pre-plan treatments for their patients.

About Post-Concussion Syndrome (PCS)
Post-concussion syndrome (PCS) also known as Chronic concussive syndrome (CCS), is a set of symptoms that may continue for weeks, months, or a year or more after a concussion - a mild form of traumatic brain injury (TBI). Concussions or mild traumatic brain injuries (mTBIs) are common among military personnel from blast wave exposure and physical injuries suffered by athletes. About 15% of individuals with a history of a single concussion develop persistent symptoms associated with the injury; those who are exposed to multiple or successive injuries are at greater risk of developing PCS. A diagnosis is typically made when symptoms resulting from concussion last for more than three months after the injury. Loss of consciousness is not required for a diagnosis of concussion or Post-concussion syndrome. Though there is no specific treatment for PCS, symptoms can be improved with medications, physical and behavioral therapy. Education about symptoms and details about expectation of recovery is important. The majority of PCS cases resolve after a period of time. PCS sufferers are also linked to an increase risk of depression, violent behavior, and suicide.

About American CryoStem Corp.
American CryoStem Corporation (OTC PINK:CRYO), is a clinical stage biotechnology company, global licensor and a pioneer in autologous cellular therapy processing. The Company has developed proprietary products to advance the Company's proprietary end-to-end personalized cellular therapy platform consisting of collection - processing - cryobanking - and return to point-of-care of adipose tissue and adipose-derived mesenchymal stems cells. The Company maintains a strategic portfolio of intellectual property and patent applications that form its Adipose Tissue Processing Platform, which supports and promotes a growing pipeline of biologic products and processes, clinical services, and international licensing opportunities. Through its ACS Laboratories division, the Company operates an FDA registered, cGMP compliant human tissue processing, cryo-storage, cell culture and differentiation laboratory facility in Monmouth Junction, New Jersey.

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Forward-Looking Statements
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. 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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