Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease
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
1 other identifier
interventional
98
2 countries
58
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2007
Typical duration for phase_3
58 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 17, 2007
CompletedFirst Submitted
Initial submission to the registry
October 11, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
April 28, 2011
CompletedMarch 11, 2026
November 1, 2025
1.8 years
October 11, 2007
March 9, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Duration of clinical benefit (Crohn's disease activity index)
6 months
Re-induction of clinical benefit (Crohn's disease activity index)
6 months
Secondary Outcomes (1)
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)
6 months
Study Arms (3)
Placebo
PLACEBO COMPARATORPlacebo
PROCHYMAL Low dose
ACTIVE COMPARATORLow dose (total of 600 million cells).
PROCHYMAL High dose
ACTIVE COMPARATORHigh dose (total of 1200 cells).
Interventions
intravenous infusion four times over two weeks; possibly repeated once
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
Study Sites (58)
Advanced Clinical Research Institute
Anaheim, California, 92801, United States
Veteran's Administration Medical Center (does not require vet status)
Long Beach, California, 90822, United States
University of Southern California University Hospital
Los Angeles, California, 90033, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Western States Clinical Research
Wheat Ridge, Colorado, 80033, United States
Gastroenterology Center of Connecticut
Hamden, Connecticut, 06518, United States
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, United States
Venture Research Institute
Miami, Florida, 33162, United States
Shafran Gastroenterology Center
Winter Park, Florida, 32789, United States
Atlanta Gastroenterology Associates
Atlanta, Georgia, 30342, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Carle Clinic Association
Urbana, Illinois, 61801, United States
Indiana University Medical Center
Indianapolis, Indiana, 46202, United States
Cotton-O'Neil Clinical Research Center
Topeka, Kansas, 66606, United States
University of Kentucky Hospital
Lexington, Kentucky, 40536, United States
University of Louisville Hospital
Louisville, Kentucky, 40202, United States
Gulf Coast Research
Baton Rouge, Louisiana, 70808, United States
National Institutes of Health
Bethesda, Maryland, 20892, United States
Metropolitan Gastroenterology Group
Chevy Chase, Maryland, 20815, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Womens Hospital
Boston, Massachusetts, 02115, United States
Clinical Pharmacology Study Group
Worcester, Massachusetts, 01610, United States
Center for Clinical Studies
Dearborn, Michigan, 48124, United States
Center for Digestive Health
Troy, Michigan, 48098, United States
University of Minnesota Hospital
Minneapolis, Minnesota, 55455, United States
St Louis Center for Clinical Studies
St Louis, Missouri, 63128, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Gastroenterology Research Associates
Cedar Knolls, New Jersey, 07927, United States
Holy Name Hospital
Teaneck, New Jersey, 07666, United States
Weill Cornell Medical College
New York, New York, 10028, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
Rochester Institute for Digestive Diseases
Rochester, New York, 14607, United States
Rochester General Hospital
Rochester, New York, 14621, United States
University Hospital and Medical Center
Stony Brook, New York, 11794, United States
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, 28207, United States
Pinehurst Medical Clinic
Pinehurst, North Carolina, 28734, United States
Wake Forest University
Winston-Salem, North Carolina, 27157, United States
Dayton Science Institute
Dayton, Ohio, 45415, United States
Gastroenterology United of Tulsa
Tulsa, Oklahoma, 74135, United States
Options Health Research
Tulsa, Oklahoma, 74137, United States
Allegheney Center for Digestive Health
Pittsburgh, Pennsylvania, 15212, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213, United States
Gastroenterology Center of the Midsouth
Germantown, Tennessee, 37138, United States
Nashville GI Specialists
Nashville, Tennessee, 37205, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
University of Texas Medical Branch
Galveston, Texas, 77555, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
University of Vermont
Burlington, Vermont, 05401, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
McGuire Research Institute
Richmond, Virginia, 23249, United States
Seattle Gastroenterology Associates
Seattle, Washington, 98133, United States
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8, Canada
Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Christopher James, PA
Mesoblast, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 11, 2007
First Posted
October 15, 2007
Study Start
September 17, 2007
Primary Completion
July 1, 2009
Study Completion
April 28, 2011
Last Updated
March 11, 2026
Record last verified: 2025-11