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Stem cell infusion shows promise for Hard-to-Treat GVHD

NCT ID NCT00284986

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 2 study tested a stem cell product called Prochymal in 11 patients with severe graft-versus-host disease (GVHD) that did not improve with standard treatments. The goal was to see if the infusion could reduce or resolve GVHD symptoms by day 28. The study measured complete or partial response and tracked side effects.

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 it works, this could offer a new treatment option for patients with severe graft-versus-host disease that hasn't responded to other therapies.
What could go wrong
This is a very small, early-phase study with only 11 participants, so results may not apply to everyone. The treatment may not work or could cause side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

11 people

The number who actually took part.

Started

Nov 2005

Finished

Feb 2007

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

6 months 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: * Participants must be 6 months to 70 years of age inclusive. * If female and of childbearing age, participants must be non-pregnant, not breast-feeding, and use adequate contraception. Male participants must use adequate contraception. * Participants must have Grade III-IV acute GVHD that has failed to respond to standard first and at least one second-line therapy. Biopsy for confirmation of both skin and gastrointestinal GVHD is not mandatory, but is recommended when feasible. Enrollment should not be delayed awaiting biopsy results. * Participants must have minimal renal function as defined by: Calculated creatinine clearance (CrCl) of \> 30 milliliters/minute (mL/min) using the Cockcroft-Gault equation. * Participant must provide written informed consent and authorization for use and disclosure of protected health information (PHI). Exclusion Criteria: * Participant has uncontrolled alcohol or substance abuse within 6 months of treatment. * Participant has any underlying or current medical or psychiatric condition that, in the opinion of the Investigator, would interfere with the evaluation of the participant (e.g., uncontrolled infection, right heart failure, pulmonary hypertension, etc.). * Participant has a clinically significant, unstable arrhythmia. * Participant has a known allergy to bovine or porcine products. * Participant is unwilling to sign consent form for the long-term follow-up study, protocol 271.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

Graft versus host disease

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27708, United States

More trials for these conditions

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