Extended Evaluation of PROCHYMAL Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
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1 Extended Evaluation of PROCHYMAL Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease Status: Completed Study Phase: Phase 3 Start Date: October 2007 Completion Date: July 2009 Condition(s): Crohn's Disease Full Title of Study A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease Overview Protocol 610 is enrolling subjects who successfully achieved clinical benefit (reduction in 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. Detailed Description A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment. PROCHYMAL adult human stem cells are manufactured from healthy, volunteer donors, extensively tested, and are stored to be available as needed. Human and animal studies have shown that the cells do not require any donor-recipient matching. The cells may have both immunosuppressive and healing benefits in Crohn's disease. The cells naturally migrate specifically to sites of inflammation, so their effects are believed to be local and self-limiting rather than systemic. Protocol 610 is an extension study offered only
2 to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603. Study Details Study Type: Interventional Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment Investigator Details Lead Sponsor: Mesoblast International Sàrl Trial Location Details Facility: Advanced Clinical Research Institute Anaheim, United States Facility: Veteran's Administration Medical Center (does not require vet status) Long Beach, United States Facility: University of Southern California University Hospital Los Angeles, United States Facility: University of California, San Francisco San Francisco, United States Facility: Western States Clinical Research Wheat Ridge, United States Facility: Gastroenterology Center of Connecticut Hamden, United States Facility: Clinical Research of West Florida Clearwater, United States Facility: Borland-Groover Clinic Jacksonville, United States Facility: Venture Research Institute Miami, United States Facility: Shafran Gastroenterology Center Winter Park, United States Facility: Atlanta Gastroenterology Associates Atlanta, United States Facility: University of Chicago Medical Center Chicago, United States Facility: Carle Clinic Association Urbana, United States
3 Facility: Indiana University Medical Center Indianapolis, United States Facility: Cotton-O'Neil Clinical Research Center Topeka, United States Facility: University of Kentucky Hospital Lexington, United States Facility: University of Louisville Hospital Louisville, United States Facility: Gulf Coast Research Baton Rouge, United States Facility: National Institutes of Health Bethesda, United States Facility: Metropolitan Gastroenterology Group Chevy Chase, United States Facility: Massachusetts General Hospital Boston, United States Facility: Brigham and Womens Hospital Boston, United States Facility: Clinical Pharmacology Study Group Worcester, United States Facility: Center for Clinical Studies Dearborn, United States Facility: Center for Digestive Health Troy, United States Facility: University of Minnesota Hospital Minneapolis, United States Facility: St Louis Center for Clinical Studies St Louis, United States Facility: Dartmouth Hitchcock Medical Center Lebanon, United States Facility: Gastroenterology Research Associates Cedar Knolls, United States Facility: Holy Name Hospital Teaneck, United States Facility: Weill Cornell Medical College New York, United States Facility: Mount Sinai School of Medicine New York, United States Facility: Rochester Institute for Digestive Diseases Rochester, United States Facility: Rochester General Hospital Rochester, United States Facility: University Hospital and Medical Center Stony Brook, United States Facility: Charlotte Gastroenterology and Hepatology Charlotte, United States Facility: Pinehurst Medical Clinic Pinehurst, United States Facility: Wake Forest University Winston-Salem, United States Facility: Dayton Science Institute Dayton, United States Facility: Gastroenterology United of Tulsa Tulsa, United States Facility: Options Health Research Tulsa, United States Facility: Allegheney Center for Digestive Health Pittsburgh, United States
4 Facility: University of Pittsburgh Pittsburgh, United States Facility: Gastroenterology Center of the Midsouth Germantown, United States Facility: Nashville GI Specialists Nashville, United States Facility: Vanderbilt University Medical Center Nashville, United States Facility: Baylor University Medical Center Dallas, United States Facility: University of Texas Medical Branch Galveston, United States Facility: Memorial Hermann Hospital Houston, United States Facility: University of Vermont Burlington, United States Facility: Digestive and Liver Disease Specialists Norfolk, United States Facility: McGuire Research Institute Richmond, United States Facility: Seattle Gastroenterology Associates Seattle, United States Facility: University of Calgary Calgary, Canada Facility: University of Alberta Hospital Edmonton, Canada Facility: Health Sciences Centre Winnipeg, Canada Facility: London Health Sciences Centre London, Canada Facility: Mount Sinai Hospital Toronto, Canada Interventions Drug: Placebo Placebo Drug: PROCHYMAL adult human mesenchymal stem cells intravenous infusion four times over two weeks; possibly repeated once Information Source ID Number: CRD 610 NCT Identifier: NCT Health Authority: Array Full Source of Clinical Trial Data: ClinicalTrials.gov processed this data on September 30, 2016 Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately
5 by this site. Please see the full source link above for retrieving further details from the government database.
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