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Could stem cells tame Crohn's? new trial tests infusion for remission

NCT ID NCT00482092

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tests whether infusions of PROCHYMAL, a type of adult stem cell, can help people with moderate-to-severe Crohn's disease who haven't responded to standard treatments. Over 300 participants will receive either stem cells or a placebo through an IV four times over two weeks. The goal is to see if the stem cells can safely induce remission and improve quality of life.

What this could mean

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

Active substance
Adult human mesenchymal stem cells (PROCHYMAL)
What this could lead to
If it works, this could offer a new treatment option for people with hard-to-treat Crohn's disease, helping them achieve remission without relying on current medications.
What could go wrong
This is an early phase 3 trial, and previous stem cell studies have had mixed results. There is no guarantee it will work better than placebo, and side effects from the infusion are possible.

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

330 people

The number who actually took part.

Started

Sep 2007

Finished

Sep 2014

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: * 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)

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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

  • 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

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815, 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

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502, United States

  • Gastroenterology Center of the Midsouth

    Germantown, Tennessee, 37138, United States

  • Gastroenterology United of Tulsa

    Tulsa, Oklahoma, 74135, United States

  • Gulf Coast Research

    Baton Rouge, Louisiana, 70808, United States

  • Health Science Centre

    Winnipeg, Manitoba, R3A 1R9, Canada

  • 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

  • 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

  • Royal Adelaide Hospital

    Adelaide, South Australia, Australia

  • Royal Melbourne Hospital

    Melbourne, Victoria, Australia

  • 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 Maryland, Baltimore

    Baltimore, Maryland, 21201, United States

  • University of Minnesota Hospital

    Minneapolis, Minnesota, 55455, United States

  • University of Otago

    Christchurch, New Zealand

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Southern California University Hospital

    Los Angeles, California, 90033, United States

  • University of Texas Health Science Center

    Houston, Texas, 77030, 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

  • Waikato Hospital

    Hamilton, New Zealand

  • 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.