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NCT00543374 Clinical Trial

Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

Crohn's Disease Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00543374
Other study ID # CRD 610
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date September 17, 2007
Est. completion date April 28, 2011

Study information
Verified date December 2021
Source Mesoblast, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

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 to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

Recruitment information / eligibility
Status Completed
Enrollment 98
Est. completion date April 28, 2011
Est. primary completion date July 2009
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28 Exclusion Criteria: - Substance abuse - Failure to receive full dose of all interventions in Protocol 603

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Placebo
Placebo
• PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once

Locations
Country Name City State
Canada University of Calgary Calgary Alberta
Canada University of Alberta Hospital Edmonton Alberta
Canada London Health Sciences Centre London Ontario
Canada Mount Sinai Hospital Toronto Ontario
Canada Health Sciences Centre Winnipeg Manitoba
United States Advanced Clinical Research Institute Anaheim California
United States Atlanta Gastroenterology Associates Atlanta Georgia
United States Gulf Coast Research Baton Rouge Louisiana
United States National Institutes of Health Bethesda Maryland
United States Brigham and Womens Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Vermont Burlington Vermont
United States Gastroenterology Research Associates Cedar Knolls New Jersey
United States Charlotte Gastroenterology and Hepatology Charlotte North Carolina
United States Metropolitan Gastroenterology Group Chevy Chase Maryland
United States University of Chicago Medical Center Chicago Illinois
United States Clinical Research of West Florida Clearwater Florida
United States Baylor University Medical Center Dallas Texas
United States Dayton Science Institute Dayton Ohio
United States Center for Clinical Studies Dearborn Michigan
United States University of Texas Medical Branch Galveston Texas
United States Gastroenterology Center of the Midsouth Germantown Tennessee
United States Gastroenterology Center of Connecticut Hamden Connecticut
United States Memorial Hermann Hospital Houston Texas
United States Indiana University Medical Center Indianapolis Indiana
United States Borland-Groover Clinic Jacksonville Florida
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States University of Kentucky Hospital Lexington Kentucky
United States 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 Louisville Hospital Louisville Kentucky
United States Venture Research Institute Miami Florida
United States University of Minnesota Hospital Minneapolis Minnesota
United States Nashville GI Specialists Nashville Tennessee
United States Vanderbilt University Medical Center Nashville Tennessee
United States Mount Sinai School of Medicine New York New York
United States Weill Cornell Medical College New York New York
United States Digestive and Liver Disease Specialists Norfolk Virginia
United States Pinehurst Medical Clinic Pinehurst North Carolina
United States Allegheney Center for Digestive Health Pittsburgh Pennsylvania
United States University of Pittsburgh Pittsburgh Pennsylvania
United States McGuire Research Institute Richmond Virginia
United States Rochester General Hospital Rochester New York
United States Rochester Institute for Digestive Diseases Rochester New York
United States St Louis Center for Clinical Studies Saint Louis Missouri
United States University of California, San Francisco San Francisco California
United States Seattle Gastroenterology Associates Seattle Washington
United States University Hospital and Medical Center Stony Brook New York
United States Holy Name Hospital Teaneck New Jersey
United States Cotton-O'Neil Clinical Research Center Topeka Kansas
United States Center for Digestive Health Troy Michigan
United States Gastroenterology United of Tulsa Tulsa Oklahoma
United States Options Health Research Tulsa Oklahoma
United States Carle Clinic Association Urbana Illinois
United States Western States Clinical Research Wheat Ridge Colorado
United States Wake Forest University Winston-Salem North Carolina
United States Shafran Gastroenterology Center Winter Park Florida
United States Clinical Pharmacology Study Group Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Mesoblast, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of clinical benefit (Crohn's disease activity index) 6 months
Primary Re-induction of clinical benefit (Crohn's disease activity index) 6 months
Secondary Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument) 6 months
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