Many patients with Crohn’s disease, a chronic condition that involves relapsing inflammation of the gastrointestinal tract and affects a half million Americans, develop advancing disease and no longer respond to therapy. To help patients that are refractory to treatment, Stony Brook University Medical Center (SBUMC) is conducting a clinical trial that infuses cells derived from adult bone marrow into patients to induce disease remission. SBUMC is the only institution on Long Island participating in this national multicenter trial of the novel treatment.
The study evaluates the safety and efficacy of Prochymal, a preparation of mesenchymal stem cells (MSCs) specially formulated for intravenous infusion. MSCs are cells derived from adult bone marrow that can modulate immune response, inhibit inflammation, and secrete factors that stimulate tissue repair. Studies have shown that Prochymal decreases inflammation associated with Crohn’s disease.
“We hope this therapy will provide an excellent alternative for patients experiencing moderate-to-severe Crohn’s disease and who have failed other treatments, such as steroid, immunosuppressant, and biologic therapies,” says Robert J. Richards, M.D., M.Sc. (pictured), principal investigator and Associate Professor of Medicine, Division of Gastroenterology/ Hepatology, SBUMC.
Participants will receive either Prochymal or a placebo treatment during the 12-month study. Medications are delivered intravenously at four separate infusions over 2 weeks. The entire treatment phase of the study lasts 4 weeks. Patients will undergo physical exams and certain medical tests prior to and at various points during treatment to determine any changes in Crohn’s disease symptoms. In addition to the study treatment, participants will receive standard therapies for Crohn’s disease.
Patients aged 18 to 70 years with Crohn’s disease who have non-obstructive disease and are non-responsive to standard therapies may be eligible for the study. Exclusion criteria include patients who had bowel surgery within the past 6 months, have symptomatic obstructive disease, a permanent colostomy, or are HIV positive.
Illustration: Stony Brook University Medical Center.
Stony Brook University Press Release (05/30/08)
Stony Brook University Medical Center Press Release (05/30/08)