The biotechnology company called Osiris Therapeutics, Inc. has developed an adult mesenchymal stem cell formulation it calls “Prochymal.” Osiris scientists have been busy subjecting Prochymal to a battery of clinical trials that include testing Prochymal as a treatment for chronic obstructive pulmonary disease, Crohn’s disease, myocardial infarction, and acute graft-versus-host disease. Now Osiris is in the process of testing Prochymal as a treatment for newly diagnosed diabetes mellitus.
This clinical trial transferred mesenchymal stem cells from unrelated adult donors into 63 pediatric and adult type diabetics to determine if such a transfer can slow the progression of this debilitating disease. Patients will randomly receive either the stem cells or a placebo. Thus far, no patients who have received the mesenchymal stem cell infusion have shown any adverse reactions, despite receiving the cells from unrelated donors and without any drugs to suppress the immune system. Additionally, no significant differences in insulin levels were observed between the placebo and the experimental group after one year of receiving the mesenchymal stem cell infusion. However, patients who had received Prochymal showed fewer severely low blood glucose concentrations hypoglycemic events) than those who had been given the placebo. The test is still ongoing, and all patients will be observed for another year.
The rationale behind this trial resides in the unique ability of mesenchymal stem cells to down-regulate the immune response. Because type 1 diabetes typically results from the patient’s immune system attacking and destroying the insulin-secreting beta cells found in the pancreatic islets, an influx of mesenchymal stem cells might be able to decelerate the destruction of the beta cells. This suppression of beta cell destruction might lead to the regeneration of the beta cells, since several stem cell populations in the pancreas and pancreatic ducts can differentiate into beta cells. Since, Prochymal is specifically designed to control inflammation, promote tissue regeneration and prevent the formation of scar tissue; it is a prime candidate agent to reduce the loss of beta cells at the onset of type 1 diabetes.
Jay Skyler, professor and medicine and deputy researcher of the Diabetes Research Institute at the University Of Miami Miller School Of Medicine commented, “This groundbreaking study in an important first step in the use of stem cells to potentially alter the course of type 1 diabetes. The ability to safely use stem cells from unrelated donors is an important finding of this study and provides new possibilities for further development and stem cell therapies for type 1 diabetes.”