Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
Completed · Phase 3 · Has a placebo group
Conditions studied: Crohn's Disease
In brief
Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in Crohn's Disease Activity Index (CDAI) of at least 100 points) in Protocol 603. Protocol 610 is evaluating the length of initial effect of PROCHYMAL® adult human mesenchymal stem cells and the ability of these cells to successfully re-induce clinical benefit.
Key facts
- Study ID
- NCT00543374
- Run by
- Mesoblast, Inc.
- People needed
- 98
- Starts
- 2007-09-17
- Expected to finish
- 2011-04-28
- Last updated by the study team
- 2026-03-11
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28
You may not qualify if…
- Substance abuse
- Failure to receive full dose of all interventions in Protocol 603
Where it is running
- Veteran's Administration Medical Center (does not require vet status) — Long Beach, California, United States
- University of Southern California University Hospital — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Western States Clinical Research — Wheat Ridge, Colorado, United States
- Gastroenterology Center of Connecticut — Hamden, Connecticut, United States
- Clinical Research of West Florida — Clearwater, Florida, United States
- Borland-Groover Clinic — Jacksonville, Florida, United States
- Venture Research Institute — Miami, Florida, United States
- Shafran Gastroenterology Center — Winter Park, Florida, United States
- Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
- University of Chicago Medical Center — Chicago, Illinois, United States
- Carle Clinic Association — Urbana, Illinois, United States
- Indiana University Medical Center — Indianapolis, Indiana, United States
- Cotton-O'Neil Clinical Research Center — Topeka, Kansas, United States
- University of Kentucky Hospital — Lexington, Kentucky, United States
- University of Louisville Hospital — Louisville, Kentucky, United States
- Gulf Coast Research — Baton Rouge, Louisiana, United States
- National Institutes of Health — Bethesda, Maryland, United States
- Metropolitan Gastroenterology Group — Chevy Chase, Maryland, United States
- Massachusetts General Hospital — Boston, Massachusetts, United States
- Brigham and Womens Hospital — Boston, Massachusetts, United States
- Clinical Pharmacology Study Group — Worcester, Massachusetts, United States
- Center for Clinical Studies — Dearborn, Michigan, United States
- Center for Digestive Health — Troy, Michigan, United States
- Advanced Clinical Research Institute — Anaheim, California, United States
Full record on ClinicalTrials.gov
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