Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) reported that it has received Institutional Review Board approval to proceed with its clinical trial to treat Type 1 Diabetes with its CELZ-201 cell therapy. The U.S. FDA had previously cleared the Company’s investigational new drug application within 30 days from submission. The company holds the notion that CELZ-201 leverages a special approach to harness the power of Perinatal Tissue Derived Cells to multi-potentialities that include self-renewal, low antigenicity, reduced toxicity and large-scale clinical expansion. The study is focused on evaluating CELZ-201 as a treatment for patients with newly diagnosed Type 1 Diabetes.
“The purpose of IRB review and approval is to assure that appropriate steps are taken to protect the rights and welfare of patients participating as subjects in the research and is an important milestone in proceeding with a clinical trial. We are pleased with achieving IRB approval expeditiously and look forward to moving forward with our Phase 1/2 clinical trial,” Said Timothy Warbington, CEO of Creative Medical Technology Holdings, Inc.
“I am excited to proceed with the CELZ-201 perinatal cell product in this study, as I believe that if successful it could result in a promising treatment for many patients with Type 1 Diabetes,” said Dr. Camillo Ricordi, Principal Investigator.
