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

March 9, 2026 updated by: Mesoblast, Inc.

A Phase III, Multicenter, Placebo-controlled, Randomized, Double-blind Durability and Retreatment Study to Evaluate the Safety and Efficacy of PROCHYMAL® (ex Vivo Cultured Adult Human Mesenchymal Stem Cells) Intravenous Infusion for the Maintenance and Re-induction of Clinical Benefit and Remission in Subjects Experiencing Treatment-refractory Moderate-to-severe Crohn's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

98

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N1
        • University of Calgary
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Health Sciences Centre
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital
  • United States
    • California
      • Anaheim, California, United States, 92801
        • Advanced Clinical Research Institute
      • Long Beach, California, United States, 90822
        • Veteran's Administration Medical Center (does not require vet status)
      • Los Angeles, California, United States, 90033
        • University of Southern California University Hospital
      • San Francisco, California, United States, 94115
        • University of California, San Francisco
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Western States Clinical Research
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Gastroenterology Center of Connecticut
    • Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Miami, Florida, United States, 33162
        • Venture Research Institute
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastroenterology Associates
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Urbana, Illinois, United States, 61801
        • Carle Clinic Association
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Medical Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • University of Kentucky Hospital
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Gulf Coast Research
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health
      • Chevy Chase, Maryland, United States, 20815
        • Metropolitan Gastroenterology Group
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02115
        • Brigham and Womens Hospital
      • Worcester, Massachusetts, United States, 01610
        • Clinical Pharmacology Study Group
    • Michigan
      • Dearborn, Michigan, United States, 48124
        • Center for Clinical Studies
      • Troy, Michigan, United States, 48098
        • Center for Digestive Health
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota Hospital
    • Missouri
      • St Louis, Missouri, United States, 63128
        • St Louis Center for Clinical Studies
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Hitchcock Medical Center
    • New Jersey
      • Cedar Knolls, New Jersey, United States, 07927
        • Gastroenterology Research Associates
      • Teaneck, New Jersey, United States, 07666
        • Holy Name Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10028
        • Weill Cornell Medical College
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14607
        • Rochester Institute for Digestive Diseases
      • Stony Brook, New York, United States, 11794
        • University Hospital and Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology
      • Pinehurst, North Carolina, United States, 28734
        • Pinehurst Medical Clinic
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University
    • Ohio
      • Dayton, Ohio, United States, 45415
        • Dayton Science Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Gastroenterology United of Tulsa
      • Tulsa, Oklahoma, United States, 74137
        • Options Health Research
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheney Center for Digestive Health
    • Tennessee
      • Germantown, Tennessee, United States, 37138
        • Gastroenterology Center of the Midsouth
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
      • Nashville, Tennessee, United States, 37205
        • Nashville GI Specialists
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University Medical Center
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch
      • Houston, Texas, United States, 77030
        • Memorial Hermann Hospital
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
      • Richmond, Virginia, United States, 23249
        • McGuire Research Institute
    • Washington
      • Seattle, Washington, United States, 98133
        • Seattle Gastroenterology Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Active Comparator: PROCHYMAL Low dose
Low dose (total of 600 million cells).
Drug: PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once
Active Comparator: PROCHYMAL High dose
High dose (total of 1200 cells).
Drug: PROCHYMAL adult human mesenchymal stem cells
intravenous infusion four times over two weeks; possibly repeated once

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of clinical benefit (Crohn's disease activity index)
Time Frame: 6 months
6 months
Re-induction of clinical benefit (Crohn's disease activity index)
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in quality of life (Inflammatory Bowel Disease Questionnaire [IBDQ] instrument)
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mesoblast, Inc.

Investigators

  • Study Director: Christopher James, PA, Mesoblast, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2007

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

April 28, 2011

Study Registration Dates

First Submitted

October 11, 2007

First Submitted That Met QC Criteria

October 12, 2007

First Posted (Estimated)

October 15, 2007

Study Record Updates

Last Update Posted (Actual)

March 11, 2026

Last Update Submitted That Met QC Criteria

March 9, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRD 610

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe