Extended Evaluation of PROCHYMAL® Adult Human Stem Cells for Treatment-Resistant Moderate-to-Severe Crohn's Disease

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Drug: PROCHYMAL adult human mesenchymal stem cells; Drug: Placebo

• Registration Number: NCT00543374
• Lead Sponsor: Mesoblast, Inc.

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.

Detailed 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 610 is an extension study offered only to those subjects who successfully achieved clinical benefit (reduction of CDAI of at least 100 points) in Protocol 603.

Study Timeline

• Study Start: 2007-09-17
• Study First Submitted: 2007-10-11
• Study First Submitted QC: 2007-10-12
• Study First Posted: 2007-10-15
• Primary Completion: 2009-07
• Disposition First Submitted: 2010-08-24
• Study Completion: 2011-04-28
• Disposition First Submitted QC: 2011-10-06
• Disposition First Posted: 2011-10-10
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-23
• Last Update Posted: 2021-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 98

Inclusion Criteria

• Participation in Osiris Protocol 603, with drop of at least 100 points in CDAI at Day 28

Exclusion Criteria

• Substance abuse
• Failure to receive full dose of all interventions in Protocol 603

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PROCHYMAL High dose	PROCHYMAL adult human mesenchymal stem cells	High dose (total of 1200 cells)
Placebo	Placebo	Placebo
PROCHYMAL Low dose	PROCHYMAL adult human mesenchymal stem cells	Low dose (total of 600 million cells)

Primary Outcome Measures

Name	Time	Method
Re-induction of clinical benefit (Crohn's disease activity index)	6 months
Duration of clinical benefit (Crohn's disease activity index)	6 months

Secondary Outcome Measures

Name	Time	Method
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)	6 months

Trial Locations

Locations (58)

University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Brigham and Womens Hospital; 🇺🇸 Boston, Massachusetts, United States

Memorial Hermann Hospital; 🇺🇸 Houston, Texas, United States

Venture Research Institute; 🇺🇸 Miami, Florida, United States

Indiana University Medical Center; 🇺🇸 Indianapolis, Indiana, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of California, San Francisco; 🇺🇸 San Francisco, California, United States

National Institutes of Health; 🇺🇸 Bethesda, Maryland, United States

Nashville GI Specialists; 🇺🇸 Nashville, Tennessee, United States

University of Southern California University Hospital; 🇺🇸 Los Angeles, California, United States

Metropolitan Gastroenterology Group; 🇺🇸 Chevy Chase, Maryland, United States

Gulf Coast Research; 🇺🇸 Baton Rouge, Louisiana, United States

Center for Clinical Studies; 🇺🇸 Dearborn, Michigan, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States

Gastroenterology Research Associates; 🇺🇸 Cedar Knolls, New Jersey, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Dartmouth Hitchcock Medical Center; 🇺🇸 Lebanon, New Hampshire, United States

Center for Digestive Health; 🇺🇸 Troy, Michigan, United States

St Louis Center for Clinical Studies; 🇺🇸 Saint Louis, Missouri, United States

Mount Sinai School of Medicine; 🇺🇸 New York, New York, United States

Gastroenterology United of Tulsa; 🇺🇸 Tulsa, Oklahoma, United States

Pinehurst Medical Clinic; 🇺🇸 Pinehurst, North Carolina, United States

University Hospital and Medical Center; 🇺🇸 Stony Brook, New York, United States

Allegheney Center for Digestive Health; 🇺🇸 Pittsburgh, Pennsylvania, United States

Options Health Research; 🇺🇸 Tulsa, Oklahoma, United States

Digestive and Liver Disease Specialists; 🇺🇸 Norfolk, Virginia, United States

Health Sciences Centre; 🇨🇦 Winnipeg, Manitoba, Canada

Seattle Gastroenterology Associates; 🇺🇸 Seattle, Washington, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

London Health Sciences Centre; 🇨🇦 London, Ontario, Canada

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Holy Name Hospital; 🇺🇸 Teaneck, New Jersey, United States

Rochester General Hospital; 🇺🇸 Rochester, New York, United States

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada

Dayton Science Institute; 🇺🇸 Dayton, Ohio, United States

University of Minnesota Hospital; 🇺🇸 Minneapolis, Minnesota, United States

Gastroenterology Center of the Midsouth; 🇺🇸 Germantown, Tennessee, United States

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States

Western States Clinical Research; 🇺🇸 Wheat Ridge, Colorado, United States

Borland-Groover Clinic; 🇺🇸 Jacksonville, Florida, United States

Veteran's Administration Medical Center (does not require vet status); 🇺🇸 Long Beach, California, United States

Cotton-O'Neil Clinical Research Center; 🇺🇸 Topeka, Kansas, United States

Carle Clinic Association; 🇺🇸 Urbana, Illinois, United States

Atlanta Gastroenterology Associates; 🇺🇸 Atlanta, Georgia, United States

Gastroenterology Center of Connecticut; 🇺🇸 Hamden, Connecticut, United States

University of Kentucky Hospital; 🇺🇸 Lexington, Kentucky, United States

Clinical Pharmacology Study Group; 🇺🇸 Worcester, Massachusetts, United States

Rochester Institute for Digestive Diseases; 🇺🇸 Rochester, New York, United States

University of Alberta Hospital; 🇨🇦 Edmonton, Alberta, Canada

McGuire Research Institute; 🇺🇸 Richmond, Virginia, United States

University of Calgary; 🇨🇦 Calgary, Alberta, Canada

University of Texas Medical Branch; 🇺🇸 Galveston, Texas, United States

Shafran Gastroenterology Center; 🇺🇸 Winter Park, Florida, United States

Advanced Clinical Research Institute; 🇺🇸 Anaheim, California, United States

Clinical Research of West Florida; 🇺🇸 Clearwater, Florida, United States

Charlotte Gastroenterology and Hepatology; 🇺🇸 Charlotte, North Carolina, United States

Wake Forest University; 🇺🇸 Winston-Salem, North Carolina, United States