Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is making strides towards revolutionizing diabetes care. The biotechnology company has recently filed an application to 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. This could potentially be a best-in-class regenerative therapeutic solution, offering hope to many.
The groundbreaking ImmCelz® (CELZ-100) immunotherapy product offers a revolutionary solution to the challenging issue of Brittle Type 1 Diabetes. Utilizing the Company’s cell-free system, ImmCelz® has the potential to supercharge the patient’s own cells to treat a number of immune disorders without the potential drawbacks associated with immunosuppression.
While human islet cell transplantation is currently under U.S. FDA review, ImmCelz® holds the promise of a definitive cure without the associated risks.
The FDA’s Office of Orphan Drug Products is dedicated to supporting the development of treatments for rare diseases that affect a small population in the U.S. Orphan drug designation brings with it numerous incentives, including market exclusivity when the drug is approved, waived FDA application fees, and tax credits for clinical trials. By granting orphan status to these medications, the FDA hopes to give hope to those affected by rare disorders.
Islet cell transplantation provides a promising solution for those suffering from brittle diabetes, offering a potential path to insulin independence. However, the current immunosuppression regimen has failed to improve single-donor success rates, necessitating a shift away from immunosuppressive therapy and towards immune-based therapies such as ImmCelz®.
This would alleviate the need for life-long, high-dose immunosuppression, which comes with serious side effects and limits the application of islet transplantation to manage brittle diabetes. With the introduction of innovative immune-based therapies, islet cell transplantation could provide a safe and effective solution for those with brittle diabetes.
ImmCelz® therapy, when given in combination with islet cells (PHPI), has the potential to revolutionize the treatment of brittle diabetes. By activating regulatory T cells, or Tregs, this novel approach has been shown to suppress the alloreactive and innate immune cells that can lead to islet transplant rejection.
Not only has the efficacy and safety of this immune therapy been established in several preclinical and clinical studies, but it also offers significant advantages over traditional immunosuppressive treatments.
We are thrilled to explore the potential for our ImmCelz® platform to help people with Type 1 Brittle Diabetes. Submitting our ODD application showcases our team’s commitment to expediting the development and deployment of our immune therapies.
We look forward to collaborating with our esteemed clinicians and new partners to make a positive shift away from immunosuppression and its associated issues. Timothy Warbington, CEO, expressed his enthusiasm.
The ImmCelz® platform is revolutionizing the field of human islet cell transplantation through the introduction of CELZ-101. This unique product offers unprecedented scalability and efficacy, providing new hope for those seeking innovative solutions to their medical needs.
About ImmCelz
ImmCelz®, a revolutionary technology protected by trade secrets and published U.S. patents, harnesses the power of adult stem cells to supercharge a patient’s immune system. By using a cell-free reprogramming “cocktail”, these harvested cells are re-injected back into the patient, providing immune-optimization while preserving the ability to detect and attack foreign pathogens. ImmCelz® is currently being developed to treat a range of medical conditions including Type I diabetes, heart disease, liver disease and kidney disease.
About Creative Medical Technology Holdings
Creative Medical Technology Holdings, Inc. is a pioneering biotechnology company with a mission to identify and develop innovative biological therapeutics in the fields of immunotherapy, endocrinology, urology, gynecology and orthopedics. As a publicly traded company on NASDAQ, CELZ offers a unique opportunity to invest in cutting-edge medical technology.