American CryoStem to file Investigational New Drug Application with FDA
EATONTOWN, NJ / ACCESSWIRE / December 13, 2018 / 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 completed its Pre-IND discussions with the FDA concerning its ongoing work to file an Investigational New Drug Application (IND) titled:''Expanded Autologous, Adipose-Derived Mesenchymal Stem Cells Deployed via Intravenous Infusion for the Treatment of Chronic Post Concussive Syndrome (CCS) in Retired Athletes and Retired US Military Servicemen'' utilizing its fully patented collect-process-store-return to point of care platform.
The planned application filing is a major milestone for the Company. CRYO has developed an autologous adipose tissue derived stem cell product ATCELL™ which will be used for the proposed Phase 1 Safety Study to treat the long term effects of repetitive traumatic brain injuries. The US Centers for Disease Control and Prevention (CDC) defines traumatic brain injury (TBI) as a disruption in the normal function of the brain that can be caused by a bump, blow, or jolt to the head, or penetrating head injury.
Post-concussion syndrome is a complex disorder in which various symptoms such as headaches and dizziness last for weeks and sometimes months after the injury that caused the concussion. In approximately 15% of people, symptoms may persist for years or be permanent. If symptoms are not resolved by one year, they are likely to be permanent, though improvements may occur after even two or three years or may suddenly occur after a long time without much improvement.
Traumatic Brain Injury is a major cause of mortality in the United States, contributing to approximately 30% of all injury-related deaths. The burden on the health care system is also substantial; in 2010, approximately 2.5 million emergency department (ED) visits, hospitalizations, or deaths were associated with TBI. From 2001 to 2010, the rates of ED visits increased by 70%, and rates of hospitalization and death increased by 11% and 7%, respectively.
The direct and indirect costs of traumatic brain injury in the U.S. have been estimated to be $48.3 billion annually. Lifetime costs for one person surviving a severe TBI can reach $4 million. An estimate of medical and non-medical per TBI survivor averages $151,587. Average costs rise dramatically for those individuals who undergo rehabilitation. In one study, after a 4-year follow-up, average costs for medical and long-term care services averaged $196,460 for survivors receiving rehabilitation services compared to $17,893 for those receiving no rehabilitation. (http://www.aboutbraininjury.org/financial-costs-of-brain-injuries/)
Recent estimates suggest that between 250,000 - 500,000 of the 2.5 million U.S. military service members deployed to Iraq and Afghanistan may be affected by TBI. The estimated costs of treatment, just for blast-related TBI in the U.S., is $2.5 billion annually. Additionally, the estimated percentage of athletes that suffer from mild cognitive impairment (MCI) due to repetitive sub-concussive or concussive brain injuries varies widely.
The Company, in preparation for this application has invested significant resources and upgraded its laboratory facility from an FDA registered tissue bank to become a biologic drug manufacturer. To accomplish this, the Company has acquired addition laboratory and clean room space, completed the installation and certification of additional equipment, upgraded air handling and filtration systems, implemented a cGMP process conversion, and product and process validations to support the production of its ATCELL™ product to be used in this planned IND filing.
Anthony Dudzinski, COO commented ''ATCELL™ is a autologous adipose tissue derived stem cell product with cellular biomarker identification through flow cytometry consistently in excess of 97%, each ATCELL™ product is genetically matched to the treated patient.'' He continued, ''The Company believes using genetically matched cells with high cellular purity and consistency for unmet medical needs such as Chronic Concussive Syndrome supports the Company's ongoing efforts to achieve regulatory approvals for its patented ATCELL™ product for a wide range of uses domestically and through its licensed affiliates in China, Japan, Hong Kong and Thailand.''
Upon acceptance of the filing by FDA and initiation of the clinical trial the Company intends to make its ATCELL™ product available for clinical study by collaborators and partners that wish to develop additional treatment protocols that have shown early promise in the treatment of neurological disorders, orthopaedic applications and tissue repair among others to rapidly expand approved uses of its ATCELL™ products in the global cellular therapy markets.
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