Dr. Aaron Vinik, principle investigator for the study at Eastern Virginia Medical School in Norfolk, is testing a new diabetes drug, Prochymal. It’s part of a first-of-its-kind study for finding a possible cure.
New Possible Bone Marrow Stem Cell Therapy for Diabetes
Jun 23, 2009
The first patient to enter the study is a 23 year old female, who was diagnosed with Type 1 diabetes within less then 18 months. She fits the very specific criteria – newly diagnosed and between the ages of 18 and 30 – to receive the drug Prochymal, which utilizes adult stem cells.
The study focuses on the drug’s ability to protect normal pancreatic tissue from autoimmune attack and repair damaged pancreatic beta cells, which could lead to an increase in insulin production and a decrease in circulating blood glucose.
Dr. Vinick explains that, “If we can reduce your insulin dose by 50 or 60 percent, many studies have shown, we reduce the likelihood of long-term complications.”
After three infusions of the new drug, no noticeable side effects have occurred, except for a minor headache.
Study participation will last about two years at 20 centers nationwide.
Researchers hope to recruit 60 patients nationwide for the study. Half of them will receive a placebo, the other half the drug.
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.
Prochymal is an investigational therapy developed by Osiris Therapeutics, Inc., containing stem cells from healthy adult volunteer donors. When the stem cells found in Prochymal are delivered intravenously, in combination with standard care, they may arrest disease progression and promote the regeneration of tissues damaged in the inflammatory process.
In addition to this research study, Prochymal is being evaluated in Phase III clinical trials for three indications, including acute and steroid-refractory Graft versus Host Disease and also Crohn’s disease.
It’s the only stem cell therapeutic currently designated by FDA as both an Orphan Drug and Fast Track product.
Prochymal is also being evaluated as a treatment for the repair of heart tissue following a heart attack and the repair of lung tissue in patients with chronic obstructive pulmonary disease.
The Strelitz Diabetes Center, Eastern Virginia Medical School