Prochymal® phase 2 Clinical Trial for the Treatment of Type 1 Diabetes
enrollment for this trial has been completed
The objective of this Phase 2 study is to evaluate the efficacy and safety of Prochymal in those patients who have been recently diagnosed with type 1 diabetes mellitus (T1DM). T1DM, or juvenile diabetes, is an autoimmune disorder where the immune system attacks and destroys the beta cells in the pancreas. These beta cells normally produce insulin, but as they are destroyed, less insulin is produced resulting in glucose accumulation in the blood. For this reason, people with type 1 diabetes must take insulin to regulate their blood sugar levels in order to avoid life-threatening hypo- and hyper-glycemic reactions. Over time, poorly controlled diabetes can lead to a variety of serious health conditions, including heart disease, stroke, blindness, amputations, kidney disease, and nerve damage. Insulin injections are the primary method of controlling diabetes by regulating blood glucose levels, but it may not reverse or prevent disease progression. The characteristics and biologic activity of Prochymal, along with a good safety profile in human trials to date, suggest that Prochymal may be a good candidate for addressing this unmet medical need.
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If you have questions about this clinical program, please email us at Diabetes@Osiris.com