Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-resistant Moderate-to-severe Crohn's Disease

Completed · Phase 3 · Has a placebo group

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT00482092

Run by

Mesoblast, Inc.

People needed

330

Starts

2007-09-17

Expected to finish

2014-09-15

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

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)

Where it is running

• 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
• University of Southern California University Hospital — Los Angeles, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.