Stem cell retreatment shows promise for tough Crohn's cases

NCT ID NCT01233960

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

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

Summary

This study looked at the safety of giving repeated doses of remestemcel-L, a stem cell therapy, to 73 people with moderate-to-severe Crohn's disease that didn't respond to standard treatments. Participants had already received the drug in an earlier study and were given three more infusions over several months. The goal was to see if retreatment was safe and could help control the disease.

What this could mean

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

Active substance: remestemcel-L (adult stem cells)
What this could lead to: If successful, this could provide a new treatment option for people with moderate-to-severe Crohn's disease that hasn't responded to standard therapies.
What could go wrong: This is a small, open-label safety study with no placebo group, so results may not prove effectiveness. Stem cell therapies can have unknown long-term risks.

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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

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Locations

Baylor University Medical Center

Dallas, Texas, 75246, United States
Chevy Chase Clinical Research

Chevy Chase, Maryland, 20815, 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
Gastroenterology Center of the Midsouth, PC

Germantown, Tennessee, 38138, United States
McGuire Research Institute

Richmond, Virginia, 23249, United States
Mount Sinai School of Medicine

New York, New York, 10029, United States
Royal Adelaide Hospital

Adelaide, South Australia, Australia
Royal Melbourne Hospital

Melbourne, Victoria, Australia
Saint Louis Center for Clinical Research

St Louis, Missouri, 63128, United States
Shafran Gastroenterology Center

Winter Park, Florida, 32789, United States
St. Louis Center for Clinical Studies

St Louis, Missouri, 63128, United States
University of California, San Francisco

San Francisco, California, 94115, United States
University of Chicago

Chicago, Illinois, 60611, United States
University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States
University of Otago

Christchurch, New Zealand
Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States
Waikato Hospital

Hamilton, New Zealand
Weill Cornell Medical College

New York, New York, 10028, United States

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