The Creative Medical Technology Holdings Investigational New Drug (IND) application has been approved by the U.S. Food and Drug Administration, allowing the company to move forward with starting a clinical trial for Type 1 Diabetes using AlloStem™.
Perinatal Tissue Derived Cells® (PRDC) have several potentialities, including self-renewal ability, low antigenicity, reduced toxicity, and broad clinical extension, and AlloStem™ exploits these potentialities to multi-potentialities.
The main goal of the study (CELZ-201) is to assess AlloStem™ in people who have just been diagnosed with Type 1 Diabetes (T1D). Patient recruitment is anticipated to start in Q1 2023, with trial commencement updates to follow.
T1D is brought on by the autoimmune destruction of the insulin-producing islet cells of the pancreas, which stops the generation of insulin and impairs blood glucose regulation.
In the absence of insulin, the body processes foods abnormally, which raises blood sugar levels. In addition to problems like kidney disease/failure, eye illness (including vision loss), heart disease, stroke, nerve damage, and even death, high blood sugar can cause diabetic ketoacidosis.
Due to the limitations and complexity of insulin delivery methods, it can be difficult to achieve and maintain balance in glucose management in T1D patients. Hypoglycemia continues to be a crucial limiting factor in managing blood sugar levels. Severe hypoglycemia can result in loss of consciousness, coma, seizures, damage, and even death.