First Trial of Adult Stem Cells to Treat Heart Attack Patients

With $50 million raised in a new funding round, Osiris Therapeutics, Inc. has begun a Phase 1 clinical trial of  Provacel, a new therapeutic based on adult mesenchymal stem cells (MSCs) found in bone marrow. Provacel is a formulation of MSCs shown in preclinical trials to repair damaged tissue. It is given to patients through a standard IV line, and the delivered cells, responding to the body’s own signals, migrate to the area of injury.

“We are extremely enthusiastic about this study which represents the first use of an allogeneic adult stem cell to treat the consequences of heart attack in humans,” said lead investigator Dr. Joshua Hare, Director of Heart Failure and Cardiac Transplantation and the Cardiobiology Section of the Institute for Cell Engineering at Johns Hopkins University School of Medicine.

“We are investigating an exciting new approach to address the unmet needs of cardiac patients,” said Dr. Nabil Dib, Chief of Cardiovascular Research at the Arizona Heart Institute, another investigator in the trial.  “According to the American Heart Association, about two thirds of heart attack patients never completely recover. This is due to the fact that heart cells can't repair themselves, so we have to try innovative ways to treat the damage that occurs at the time of heart attack. If the research conducted to date is any indication, mesenchymal stem cells may be the answer.”

The stem cells produced by Osiris are obtained from adult volunteer donors, not embryos, so there's no controversy about their use. Cells are grown in culture to very high numbers, allowing a single donor's cells to treat hundreds of patients. These cells are universal in that they can be used in patients unrelated to the donor, without rejection, eliminating the need for donor matching and immune suppression. Once transplanted, the cells promote healing of damaged or diseased tissues.

Osiris's goal is to use adult stem cells to improve outcomes in bone marrow recipients being treated for leukemia, to promote cardiac repair following a heart attack or congestive heart failure, and to prevent arthritis. Osiris recently became the first company to receive Fast Track designation from FDA for a similar stem cell product, Prochymal, for the treatment of graft versus host disease in cancer patients.

For more about the the company and its money-raising, see "The other stem cells" by Diedtra Henderson in last month's Boston Globe.

(Osiris's web site at www.OsirisTX.com is not compatible with most web browsers. Use Microsoft's Internet Explorer Version 6.0 to see the layout and graphics.)