Prochymal for Treatment of Type 1 Diabetes

Type 1 diabetes mellitus, commonly known as juvenile diabetes or insulin-dependent diabetes, is an autoimmune disorder that attacks and destroys insulin producing islet cells in the pancreas, resulting in glucose accumulation in the blood. Those suffering from type 1 diabetes must take insulin to regulate blood sugar levels. Improper management of diabetes can result in serious health conditions, including heart disease, stroke, blindness, amputations, kidney disease and nerve damage. Currently, there are no preventive measures for type 1 diabetes.

Prochymal for Type 1 Diabetes Clinical Status

The Phase II trial is evaluating the safety and efficacy of Prochymal in conjunction with standard of care in preserving insulin production in patients recently diagnosed with type 1 diabetes mellitus. The design will be a double-blind, placebo-controlled trial at multiple sites with a target enrollment of 60 patients, and patients will be randomized to either Prochymal or placebo at a 2:1 ratio. The primary endpoint of the trial will be the measurement of C-peptide produced during a Mixed Meal Tolerance Test in patients treated with Prochymal, compared to those receiving placebo. This test is frequently used in diabetic patients to determine how much insulin is being produced by the pancreas in response to glucose stimulation.

For more information about our type 1 diabetes clinical trial, please see our Prochymal clinical trial page or contact us for more information via e-mail at Osiris@Osiris.com.