Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease
NCT ID: NCT00482092
Last Updated: 2022-01-13
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
330 participants
INTERVENTIONAL
2007-09-17
2014-09-15
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 603 is enrolling subjects to evaluate the ability of PROCHYMAL to induce remission in subjects with moderate-to-severe disease (Crohn's disease activity index -- CDAI -- of between 250 and 450, inclusive) who have failed or been intolerant of at least one drug in each of the steroid, immunosuppressant, and biologic classes.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
Participants will receive matching placebo administered as intravenous (IV) infusions.
Placebo
Prochymal® Placebo-matching IV infusion
Prochymal® - Low dose
Participants will receive a total dose of Prochymal® 600 x 10\^6 cells, IV infusion, on four days, once daily.
Prochymal®
Prochymal® IV infusion
Prochymal® - High dose
Participants will receive a total dose of Prochymal® 1200 x 10\^6 cells, IV infusion, on four days, once daily.
Prochymal®
Prochymal® IV infusion
Interventions
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Prochymal®
Prochymal® IV infusion
Placebo
Prochymal® Placebo-matching IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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)
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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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
Clinical Research of West Florida
Clearwater, Florida, United States
Borland-Groover Clinic
Jacksonville, 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
University of Maryland, Baltimore
Baltimore, Maryland, United States
National Institutes of Health
Bethesda, Maryland, United States
Chevy Chase Clinical Research
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
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
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
University of Texas Health Science Center
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
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
University of Calgary
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
Health Science Centre
Winnipeg, Manitoba, Canada
London Health Sciences Centre
London, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
University of Otago
Christchurch, , New Zealand
Waikato Hospital
Hamilton, , New Zealand
Countries
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Other Identifiers
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CRD 603
Identifier Type: -
Identifier Source: org_study_id
NCT00609232
Identifier Type: -
Identifier Source: nct_alias
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