Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ), a biotechnology company working to revolutionize care through the development of potentially best-in-class regenerative therapeutics, today announced that it has received Institutional Review Board (IRB) approval to proceed with its Clinical Trial for the treatment of Type 1 Diabetes with its CELZ-201 cell therapy.
The U.S. Food and Drug Administration (FDA) had previously cleared the Company’s Investigational New Drug (IND) application within 30 days from submission.
The Company believes that CELZ-201 leverages a unique approach to harnessing the power of Perinatal Tissue Derived Cells® (PRDC) to multi-potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and large-scale clinical expansion. The primary objective of the study is to evaluate CELZ-201 as a treatment for patients with newly diagnosed Type 1 Diabetes.
The company sponsored trial will be conducted at the University of Miami Health System in conjunction with the Diabetes Research Institute.
“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.
Safety and Efficacy of CELZ-201 in Patients With Recent Onset Type 1 Diabetes – Full Text View – ClinicalTrials.gov