Paramus, New Jersey (April 24, 2024) - Throne Biotechnologies is one of the global-leading biotech companies aiming to find a cure for type 1 diabetes. We are excited to announce that Throne achieved the FDA approval on the Regenerative Medicine Advanced Therapy (RMAT) designation by using Stem Cell Educator therapy to treat type 1 diabetes. RMAT designation is one of the expedited FDA programs for regenerative medicine therapies to treat patients with serious or life-threating diseases.
Type 1 diabetes (T1D), one of the popular autoimmune diseases, requires life-long management with daily insulin injections. Insulin therapy is not a cure. Most diabetic patients cannot achieve the physiological sugar controls by using current expansive advanced technologies such as continuous glucose monitoring systems (CGMS), insulin delivery systems, wearables, and mobile medical apps. The quality of life in T1D patients has been significantly affected by the disappointing outcomes of recent clinical trials, which have highlighted the limits of conventional immune therapy and underscore the need for novel approaches that not only overcome multiple immune dysfunctions, but also help restore islet β cells. To address these two key issues, Dr. Yong Zhao at Throne Biotechnologies (Throne) has developed a unique and novel procedure designated the Stem Cell Educator therapy. With this patented technology, the patient’s immune cells are collected by a blood cell separator and treated with cord-blood-derived multipotent stem cells (CB-SC), after which “educated” immune cells (Gleukocellâ) are returned to the patient’s blood circulation. Over the last 12 years, this innovative technology has been evaluated through international multi-center clinical studies, which have demonstrated its efficacy and safety. Stem Cell Educator therapy is the only therapy to date to safely and efficiently correct autoimmunity and restore β cell function in T1D patients. Additional pilot studies demonstrated the therapeutic potentials of Stem Cell Educator therapy to heal patients with other autoimmune or inflammation-associated diseases such as alopecia areata (AA), type 2 diabetes (T2D), lupus, psoriasis, Hashimoto’s disease, and long COVID. Stem Cell Educator therapy hold great promise to revolutionize the treatment of diabetes and eliminate the need for lifelong insulin therapy, without the safety and ethical concerns associated with conventional immune and/or stem cell-based approaches.