Osiris Therapeutics, Inc, of Baltimore, Maryland, has announced the start of enrollment for its phase II clinical trial of Prochymalâ„¢ for the treatment of Crohn's disease. An intravenous formulation of mesenchymal stem cells obtained from the bone marrow of healthy volunteer donors, Prochymal is being evaluated for its ability to reduce inflammation and repair damaged intestinal tissue in patients with moderate to severe Crohn's disease who have failed to respond to steroids and other immunosuppressive agents. If approved by the US Food and Drug Administration, Prochymal may help treat the 70% of Crohn's patients who require major surgery of their intestines, according to the company.
Osiris's proprietary methods allow large numbers of adult stem cells from volunteer donors to be grown in cultures, processes that permit a single donor's cells to treat thousands of unrelated patients without rejection, eliminating the need for donor-matching and recipient immune suppression.
Among its other adult stem cell clinical trials, Osiris has an ongoing phase I/II trial of Chondrogenâ„¢ for the regeneration of cartilage tissue in the knee.
—A. Techman