Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
NCT ID: NCT00543374
Last Updated: 2021-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
98 participants
INTERVENTIONAL
2007-09-17
2011-04-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Placebo
Placebo
Placebo
PROCHYMAL Low dose
Low dose (total of 600 million cells)
PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once
PROCHYMAL High dose
High dose (total of 1200 cells)
PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once
Interventions
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Placebo
Placebo
PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Failure to receive full dose of all interventions in Protocol 603
18 Years
70 Years
ALL
No
Sponsors
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Mesoblast, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Mahboob Rahman, MD
Role: STUDY_DIRECTOR
Mesoblast, Inc.
Locations
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Advanced Clinical Research Institute
Anaheim, California, 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 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
University of Minnesota Hospital
Minneapolis, Minnesota, United States
St Louis Center for Clinical Studies
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, United States
Holy Name Hospital
Teaneck, New Jersey, United States
Weill Cornell Medical College
New York, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Rochester Institute for Digestive Diseases
Rochester, New York, United States
Rochester General Hospital
Rochester, New York, United States
University Hospital and Medical Center
Stony Brook, New York, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, United States
Wake Forest University
Winston-Salem, North Carolina, United States
Dayton Science Institute
Dayton, Ohio, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, United States
Options Health Research
Tulsa, Oklahoma, United States
Allegheney Center for Digestive Health
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Gastroenterology Center of the Midsouth
Germantown, Tennessee, United States
Nashville GI Specialists
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor University Medical Center
Dallas, Texas, United States
University of Texas Medical Branch
Galveston, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
University of Vermont
Burlington, Vermont, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States
McGuire Research Institute
Richmond, Virginia, United States
Seattle Gastroenterology Associates
Seattle, Washington, United States
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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Other Identifiers
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CRD 610
Identifier Type: -
Identifier Source: org_study_id