The first clinical trials in the United States of a novel cell therapy that could rebuild the hearts of hundreds of thousands of heart attack victims has begun at The Johns Hopkins University School of Medicine and the Arizona Heart Institute. The current Phase I clinical trial is designed to test the basic safety for humans of a new cell replacement therapy developed by Osiris Therapeutics Inc. of Baltimore Maryland with support from the National Institute of Standards and Technology (NIST).
The Osiris technique uses mesenchymal stem cells produced in the bone marrow of adults. While not as versatile as embryonic stem cells, MSCs can be differentiated by the body to develop into fat, cartilage, bone, tendon, or muscle cells. The trick is to identify the specific biochemical factors that cause MSCs to develop into a desired form, such as cardiac muscle cells, an d then induce them to do so at the right place and time. Osiris Therapeutics won a 1997 cost-sharing award from the NIST Advanced Technology Program to develop the basic technology to use MSCs to replace damaged heart muscle cells.
Previous animal studies have validated the approach – adult MSCs injected directly into the heart muscle have restored nearly total heart function within two months. If the technique works as well in humans, it has the potential to revolutionize the treatment of heart-attack patients. According to the American Heart Association, o ver 7 million Americans have suffered from heart attacks, and there are over 500,000 cases of new heart attacks and 300,000 cases of recurrent heart attacks each year.
The Phase 1 trials are expected to last from18 to24 months, after which the study may be expanded to assess the response in larger patient populations in Phase 2 and Phase 3 studies. Further details of the Phase 1 study are available at http://www.osiristx.com.