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 Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Induction of Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease
1 other identifier
interventional
330
4 countries
56
Brief Summary
Protocol 603 is enrolling subjects with moderate-to-severe Crohn's disease who are intolerant to, or have previously failed therapy with, at least one steroid and at least one immunosuppressant and a biologic monoclonal anti-body to tumor necrosis factor alpha. The protocol investigates the safety and efficacy of using PROCHYMAL® adult human stem cells to induce remission. PROCHYMAL is delivered through a vein in the arm four times over two weeks, for approximately an hour each time.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2007
Longer than P75 for phase_3
56 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
First Submitted
Initial submission to the registry
May 30, 2007
CompletedFirst Posted
Study publicly available on registry
June 4, 2007
CompletedStudy Start
First participant enrolled
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2014
CompletedMarch 11, 2026
November 1, 2025
7 years
May 30, 2007
March 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Disease remission (CDAI at or below 150)
28 days
Secondary Outcomes (3)
Disease improvement (Reduction by at least 100 points in CDAI)
28 days
Improvement in quality of life (IBDQ)
28 days
Reduction in number of draining fistulas
28 days
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will receive matching placebo administered as intravenous (IV) infusions.
Prochymal® - Low dose
ACTIVE COMPARATORParticipants will receive a total dose of Prochymal® 600 x 10\^6 cells, IV infusion, on four days, once daily.
Prochymal® - High dose
ACTIVE COMPARATORParticipants will receive a total dose of Prochymal® 1200 x 10\^6 cells, IV infusion, on four days, once daily.
Interventions
Prochymal® IV infusion
Eligibility Criteria
You may qualify if:
- failed (within last 2 yr) or intolerant of at least one steroid AND at least one immunosuppressant AND at EXACTLY one biologic
- CDAI between 250 and 450, inclusive
- endoscopically or radiographically confirmed Crohn's disease of ileus or colon or both
- C-Reactive Protein Test (CRP) of at least 5 mg/l (0.5 mg/dl)\*OR\* CDAI of at least 300
- weight between 40 and 150 kg, inclusive
- adequate renal function
- negative tuberculosis skin (PPD) test (or evaluated low risk of TB activation)
You may not qualify if:
- HIV or hepatitis infection active
- allergy to CT contrast agents, or to bovine or porcine products
- symptomatic fibrostenotic Crohn's disease
- permanent ostomy
- biologic therapy within past 90 d
- prednisone greater than 20 mg/d within past month
- short-bowel syndrome
- total parenteral nutrition
- abnormal liver function
- malignancy active within past 5 years (except completely resected basal or squamous cell carcinoma of skin)
- enteric pathogens, including C. difficile
- history of colonic mucosal dysplasia
- current or prior evidence of tuberculosis (TB) (unless risk of activation or re-activation deemed low)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mesoblast, Inc.lead
Study Sites (56)
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
Clinical Research of West Florida
Clearwater, Florida, 33765, United States
Borland-Groover Clinic
Jacksonville, Florida, 32256, 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
University of Maryland, Baltimore
Baltimore, Maryland, 21201, United States
National Institutes of Health
Bethesda, Maryland, 20892, United States
Chevy Chase Clinical Research
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
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
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
University of Texas Health Science Center
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
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
University of Calgary
Calgary, Alberta, T2N 4N1, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2X8, Canada
Health Science Centre
Winnipeg, Manitoba, R3A 1R9, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5, Canada
University of Otago
Christchurch, New Zealand
Waikato Hospital
Hamilton, New Zealand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mahboob Rahman, MD
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
May 30, 2007
First Posted
June 4, 2007
Study Start
September 17, 2007
Primary Completion
September 15, 2014
Study Completion
September 15, 2014
Last Updated
March 11, 2026
Record last verified: 2025-11