Creative Medical Technology files FDA ODD application for Brittle Type 1 diabetes

pharmafile | March 24, 2023 | News story | Medical Communications  

US-based biotech company Creative Medical Technology has announced that it has filed for the FDA’s Orphan Drug Designation (ODD) for its treatment for Brittle Type 1 diabetes.


ImmCelz (CELZ-100) uses donated stem cells to transfer specific properties to the patient’s immune cells. The cells are then incubated in Creative Medical’s cell-free reprogramming system, after which they are re-injected back into the patient. These ‘supercharged’ cells then re-educate the others in the patient’s immune system to stop attacking the body while maintaining the ability to attack foreign pathogens, thus preserving immune-optimisation.


The treatment has already been validated for use in immune disorders. For this designation – ImmCelz (CELZ-100) combined with islet cells (PHPI) – it has been assigned CELZ-101.


Courtney Bartlett, DNP – director of Clinical Operations at Creative Medical Technology, explained: “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.”


Timothy Warbington, CEO of Creative Medical Technology, stated: “We are very excited with the possibility that our ImmCelz platform can be utilised to help patients with Type 1 Brittle diabetes. The filing of our ODD application further demonstrates our team’s ability to accelerate development and implementation of our immune therapies. We look forward to working with our clinicians and new collaborators who want to make an impact on moving away from immunosuppression and its complications.”


James Spargo

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