Creative Medical Technology Files Orphan Drug Designation Application with the U.S. FDA Using the ImmCelz® Platform for the Treatment of Brittle Type 1 Diabetes

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[{"type":"text","content":"PHOENIX, March 23, 2023 /PRNewswire/ -- 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 filed an application with the U.S. Food and Drug Administration (FDA) to receive Orphan Drug Designation (ODD) for the treatment of Brittle Type 1 Diabetes using its ImmCelz®(CELZ-100) platform.\n\n \n \n \n \n \n \n\n \nThe ImmCelz® (CELZ-100) immunotherapy product utilizes the Company's cell-free system which has previously been validated to supercharge the patient's own cells to treat a number of immune disorders. Currently there is no FDA approved therapy for a definitive cure of Brittle Type 1 Diabetes. Human islet cell transplantation has been tried in Brittle Type 1 Diabetes patients and is currently under U.S. FDA review; however, it requires immunosuppression which has many potential concerns and complications.\nThe FDA's Office of Orphan Drug Products grants orphan status to support the development of medicines for rare disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain benefits, including market exclusivity upon regulatory approval, if received, exemption of FDA application fees, and tax credits for qualified clinical trials.\n\"Human islet cell transplantation is a relatively new procedure used in people with difficult to control brittle diabetes. Patients who receive an islet transplant take medication that suppresses their immune system and prevents rejection of the islet tissue. In spite of the strengths of the current immunosuppression regimen, it has failed to enhance single-donor success rates, and the majority of patients require two or more islet transplants to achieve insulin independence. As such, there is an impetus to move away from the use of immunosuppressive therapy and instead shift toward developing immune therapies such as ImmCelz® to fight against transplant rejection and autoimmunity. The need for life-long, high-dose immunosuppression is also associated with substantial side effects, and continues to limit application of islet transplantation to manage brittle diabetes,\" said Courtney Bartlett, DNP – Director of Clinical Operations.\nImmCelz® therapy, when co-administered with islet cells (PHPI...

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