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Stem cell retreatment shows promise for tough Crohn's cases

NCT ID NCT01233960

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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.

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

73 people

The number who actually took part.

Started

Nov 2010

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: * Participant must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010. * Participant successfully completed all screening assessments in Protocol 603 as required by Protocol 603. * Participant successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010. * Participant must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603. * Participant must provide written ICF and authorization for use and disclosure of PHI for Protocol 611. Exclusion Criteria: * Participant is unwilling or unable to adhere to requirements of Protocol 611. * Participant had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study. * Participant had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.

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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

  • 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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