Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can stem cells tame Crohn's? new trial tests Long-Term relief

NCT ID NCT00543374

Disease control Sponsor: Mesoblast, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial tested a stem cell treatment called PROCHYMAL in 98 people with moderate-to-severe Crohn's disease who had already responded to an earlier stem cell dose. The goal was to see how long the benefit lasts and whether a repeat dose can bring back symptom relief. Participants received four intravenous infusions over two weeks, with a possible repeat course.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PROCHYMAL (adult human mesenchymal stem cells)
What this could lead to
If successful, this could provide a new treatment option for people with Crohn's disease who don't respond to standard therapies, helping them achieve longer periods of symptom control.
What could go wrong
This is a small phase 3 trial (98 people) and results may not apply to all patients. The treatment may not work for everyone, and there could be side effects from the stem cell infusion.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

98 people

The number who actually took part.

Started

Sep 2007

Finished

Apr 2011

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Crohn's disease are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn's disease

Contacts and locations

Locations

  • Advanced Clinical Research Institute

    Anaheim, California, 92801, United States

  • Allegheney Center for Digestive Health

    Pittsburgh, Pennsylvania, 15212, United States

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30342, United States

  • Baylor University Medical Center

    Dallas, Texas, 75246, United States

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256, United States

  • Brigham and Womens Hospital

    Boston, Massachusetts, 02115, United States

  • Carle Clinic Association

    Urbana, Illinois, 61801, United States

  • Center for Clinical Studies

    Dearborn, Michigan, 48124, United States

  • Center for Digestive Health

    Troy, Michigan, 48098, United States

  • Charlotte Gastroenterology and Hepatology

    Charlotte, North Carolina, 28207, United States

  • Clinical Pharmacology Study Group

    Worcester, Massachusetts, 01610, United States

  • Clinical Research of West Florida

    Clearwater, Florida, 33765, United States

  • Cotton-O'Neil Clinical Research Center

    Topeka, Kansas, 66606, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Dayton Science Institute

    Dayton, Ohio, 45415, United States

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502, United States

  • Gastroenterology Center of Connecticut

    Hamden, Connecticut, 06518, United States

  • Gastroenterology Center of the Midsouth

    Germantown, Tennessee, 37138, United States

  • Gastroenterology Research Associates

    Cedar Knolls, New Jersey, 07927, United States

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135, United States

  • Gulf Coast Research

    Baton Rouge, Louisiana, 70808, United States

  • Health Sciences Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • Holy Name Hospital

    Teaneck, New Jersey, 07666, United States

  • Indiana University Medical Center

    Indianapolis, Indiana, 46202, United States

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • McGuire Research Institute

    Richmond, Virginia, 23249, United States

  • Memorial Hermann Hospital

    Houston, Texas, 77030, United States

  • Metropolitan Gastroenterology Group

    Chevy Chase, Maryland, 20815, United States

  • Mount Sinai Hospital

    Toronto, Ontario, M5G 1X5, Canada

  • Mount Sinai School of Medicine

    New York, New York, 10029, United States

  • Nashville GI Specialists

    Nashville, Tennessee, 37205, United States

  • National Institutes of Health

    Bethesda, Maryland, 20892, United States

  • Options Health Research

    Tulsa, Oklahoma, 74137, United States

  • Pinehurst Medical Clinic

    Pinehurst, North Carolina, 28734, United States

  • Rochester General Hospital

    Rochester, New York, 14621, United States

  • Rochester Institute for Digestive Diseases

    Rochester, New York, 14607, United States

  • Seattle Gastroenterology Associates

    Seattle, Washington, 98133, United States

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789, United States

  • St Louis Center for Clinical Studies

    St Louis, Missouri, 63128, United States

  • University Hospital and Medical Center

    Stony Brook, New York, 11794, United States

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2X8, Canada

  • University of Calgary

    Calgary, Alberta, T2N 4N1, Canada

  • University of California, San Francisco

    San Francisco, California, 94115, United States

  • University of Chicago Medical Center

    Chicago, Illinois, 60637, United States

  • University of Kentucky Hospital

    Lexington, Kentucky, 40536, United States

  • University of Louisville Hospital

    Louisville, Kentucky, 40202, United States

  • University of Minnesota Hospital

    Minneapolis, Minnesota, 55455, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California University Hospital

    Los Angeles, California, 90033, United States

  • University of Texas Medical Branch

    Galveston, Texas, 77555, United States

  • University of Vermont

    Burlington, Vermont, 05401, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Venture Research Institute

    Miami, Florida, 33162, United States

  • Veteran's Administration Medical Center (does not require vet status)

    Long Beach, California, 90822, United States

  • Wake Forest University

    Winston-Salem, North Carolina, 27157, United States

  • Weill Cornell Medical College

    New York, New York, 10028, United States

  • Western States Clinical Research

    Wheat Ridge, Colorado, 80033, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.