Osiris Therapeutics, Inc. (NASDAQ: OSIR), today provided an update on its Phase 2 trial evaluating Prochymal, a formulation of adult mesenchymal stem cells (MSCs), in patients with newly diagnosed type 1 diabetes. This first-of-its kind trial, conducted in partnership with JDRF, is testing MSCs from unrelated adult donors in 63 pediatric and adult patients to assess the safety of MSCs in this population and whether the treatment shows signs of slowing progression of the disease. Participants were randomly assigned to receive either Prochymal or placebo, and both the physicians and patients remain blinded as to which patients received stem cells.
The interim assessment at one year showed that systemic infusions of Prochymal were well-tolerated in this unique population. There were no differences in adverse event rates between the Prochymal and placebo groups. Importantly, no patients experienced a reaction to the infusions despite the cells being unrelated to the recipient, unmatched, and used without immunosuppression. No significant differences in the rates of disease progression, as measured by stimulated C-peptide levels at the one year time point, have been observed. However there was a trend towards fewer hypoglycemic events for patients treated with Prochymal as compared to controls. The patients will be followed for another year (for a total of two years), after which time a complete analysis of the data will be conducted.
"This groundbreaking study is an important first step in the use of stem cells to potentially alter the course of type 1 diabetes," said Jay S. Skyler, M.D., Professor of Medicine and Deputy Director of the Diabetes Research Institute at the University of Miami Miller School of Medicine. "The ability to safely use stem cells from unrelated donors is an important finding of this study and provides new possibilities for further development of stem cell therapies for type 1 diabetes."
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