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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00482092
• Other study ID #: CRD 603
• Status: Completed
• Phase: Phase 3
• Start date: September 17, 2007
• Est. completion date: September 15, 2014

Study information

• Verified date: January 2022
• Source: Mesoblast, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

A significant number of individuals with Crohn's disease do not find relief with existing steroidal, immunosuppressive, or biologic therapies, and are forced to seek surgery or other drastic measures for treatment.

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.

Other known NCT identifiers

• NCT00609232

Recruitment information / eligibility

• Status: Completed
• Enrollment: 330
• Est. completion date: September 15, 2014
• Est. primary completion date: September 15, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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)

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Prochymal®
Prochymal® IV infusion
• Placebo
Prochymal® Placebo-matching IV infusion

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Melbourne Hospital	Melbourne	Victoria
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Health Science Centre	Winnipeg	Manitoba
New Zealand	University of Otago	Christchurch
New Zealand	Waikato Hospital	Hamilton
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	University of Maryland, Baltimore	Baltimore	Maryland
United States	Gulf Coast Research	Baton Rouge	Louisiana
United States	National Institutes of Health	Bethesda	Maryland
United States	Brigham and Womens Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont	Burlington	Vermont
United States	Charlotte Gastroenterology and Hepatology	Charlotte	North Carolina
United States	Chevy Chase Clinical Research	Chevy Chase	Maryland
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Baylor University Medical Center	Dallas	Texas
United States	Center for Clinical Studies	Dearborn	Michigan
United States	University of Texas Medical Branch	Galveston	Texas
United States	Gastroenterology Center of the Midsouth	Germantown	Tennessee
United States	University of Texas Health Science Center	Houston	Texas
United States	Indiana University Medical Center	Indianapolis	Indiana
United States	Borland-Groover Clinic	Jacksonville	Florida
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	University of Kentucky Hospital	Lexington	Kentucky
United States	University of Southern California University Hospital	Los Angeles	California
United States	University of Louisville Hospital	Louisville	Kentucky
United States	University of Minnesota Hospital	Minneapolis	Minnesota
United States	Nashville GI Specialists	Nashville	Tennessee
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Digestive and Liver Disease Specialists	Norfolk	Virginia
United States	Pinehurst Medical Clinic	Pinehurst	North Carolina
United States	Allegheney Center for Digestive Health	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	McGuire Research Institute	Richmond	Virginia
United States	Rochester General Hospital	Rochester	New York
United States	Rochester Institute for Digestive Diseases	Rochester	New York
United States	St Louis Center for Clinical Studies	Saint Louis	Missouri
United States	University of California, San Francisco	San Francisco	California
United States	Seattle Gastroenterology Associates	Seattle	Washington
United States	University Hospital and Medical Center	Stony Brook	New York
United States	Cotton-O'Neil Clinical Research Center	Topeka	Kansas
United States	Center for Digestive Health	Troy	Michigan
United States	Gastroenterology United of Tulsa	Tulsa	Oklahoma
United States	Options Health Research	Tulsa	Oklahoma
United States	Carle Clinic Association	Urbana	Illinois
United States	Western States Clinical Research	Wheat Ridge	Colorado
United States	Wake Forest University	Winston-Salem	North Carolina
United States	Shafran Gastroenterology Center	Winter Park	Florida
United States	Clinical Pharmacology Study Group	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Mesoblast, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease remission (CDAI at or below 150)		28 days
Secondary	Disease improvement (Reduction by at least 100 points in CDAI)		28 days
Secondary	Improvement in quality of life (IBDQ)		28 days
Secondary	Reduction in number of draining fistulas		28 days