Patients with myocardial infarction who received an new intravenous adult stem cell therapy, Provacel, experienced a lower number of adverse events, such as cardiac arrhythmias, and had significant improvements in heart, lung and global function compared to those who received a placebo, according to six-month Phase I study data.

Patients receiving Provacel were 75% 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.

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 development, 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.

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.

Source: Rush University Medical Center, 2007

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