EATONTOWN, NJ / ACCESSWIRE / August 22, 2019 / American CryoStem Corporation (OTC PINK:CRYO) a leading strategic developer, marketer and global licensor of patented adipose tissue-based cellular products and technologies for the Regenerative and Personalized Medicine industries, today announced that it has engaged The Institute of Regenerative Cellular Medicine (IRCM) www.ircm.org to perform the Institutional Review Board (IRB) requirement related to the Company’s Investigational New Drug (IND) filing with the FDA, titled; “ATCell™ Expanded Autologous Adipose Derived Mesenchymal Stem Cells deployed via Intravenous Infusion for the Treatment of Post Concussion Syndrome (PCS) in Retired Athletes and Military Personnel”.
The IRCM is a non-profit 501(c)(3) registered with the U.S. Department of Health and Human Services (HHS) and is qualified under the regulations to provide the required oversight. The FDA requires oversight of all IND clinical studies by an IRB.
Anthony Dudzinski, COO of American CryoStem commented, ”The Company continues to prepare to file its full IND application with the FDA. The retention of IRCM to perform the IRB oversight requirements is a significant step in completing our IND filing. We look forward to the successful filing of the document.”
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SOURCE: American CryoStem Corporation
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