Rush was one of 10 premier cardiac centers across the country that participated in the 53-patient, double-blind, placebo-controlled trial. Among other findings, patients receiving Provacel were 75 percent less likely to experience an arrhythmic adverse event compared to those receiving placebo (9 % vs. 37%, p=0.025) and significantly more patients who received Provacel experienced improvement in their overall condition at six months as compared to those receiving placebo (42% vs. 11%, p=0.027).
Provacel is a preparation of adult stem cells pre-formulated for intravenous delivery by the drug's manufacture, Osiris Therapeutics. Patients were administered an infusion of either Provacel or placebo within 10 days of having a heart attack and are being followed for 2 years. To prevent bias, neither the patient nor the physician knows who received the stem cell treatment and who received placebo.
Rush principal investigator cardiologist Dr. Gary Schaer, head of the Rush Cardiac Catheterization Laboratory, says one reason the study results are so promising is that these stem cells can be used without tissue typing and do not trigger an immune response, and are available for every patient.
The mesenchymal stem cells (MSC) are found in the adult bone marrow and have the potential to develop into mature heart cells and new blood vessels. The MSC cells are derived from normal, healthy adult volunteer bone marrow donors and are not derived from a fetus, embryo or animal. Because they are in an early stage of developm ent, it is believed that they do not trigger an immune response when placed in someone else's body.
Similar to Blood Type O, these MSCs are being used without tissue type matching to a specific patient.
A unique benefit of the stem cell product is that it is given to patients through a standard IV line. Other therapies require delivery to the site of the disease through catheterization or open surgical procedures, but this one was very simple and easy for the patient.
Schaer says the cells were grown in culture to very high numbers, allowing a single donor's cells to treat thousands of patients. "The cells have the ability to expand, or multiply, under controlled conditions, and the expanded cells have the ability to develop into different types of cells in the appropriate environment. One donation can produce billions of MSCs. The cells can be stored for years in a frozen state, ready to be used when they are needed."
Adult stem cells are designed by nature to perform tissue repair in a mature adult. It is believed that these cells can be used in patients unrelated to the donor, without rejection, eliminating the need for donor matching and recipient immune suppression. Once transplanted, the cells promote healing of damaged or diseased tissues.
"Because of the participation by top tier sites such as Rush University Medical Center, we were able to conduct a study that was exceptionally well planned and executed" said C. Randal Mills Ph.D., President and CEO of Osiris Therapeutics. "We were confident in the safety profile given our previous experience using the intravenous form of these stem cells to treat other diseases in later stage clinical trials. However, we did not expect to see the across-the-board clinical improvement observed in patients at this early stage of testing."