American CryoStem Engages IRB for IND Filling with the FDA
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.”
For further detailed Corporate or Regenerative Medicine information please visit:
www.americancryostem.com, request by email at info@americancryostem.com or phone 732-747-1007
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