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New cell therapy aims to stop transplant complications in blood cancer patients

NCT ID NCT04328714

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 early-phase study tested whether a special type of cell (interferon gamma-primed mesenchymal stromal cells) could be safely given to prevent graft-versus-host disease, a common and serious complication after bone marrow transplant. Only 4 patients with acute leukemia or myelodysplastic syndrome were enrolled before the study was stopped. The main goals were to see if the cells could be prepared and delivered safely, and to find the best dose.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

4 people

The number who actually took part.

Started

Dec 2021

Finished

Jul 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

1 year and older

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: * All transplant patients who undergo HCT with a myeloablative (MA) or Fludarabine/Melphalan (RIC) conditioning regimen and a HLA A- B- C- DR-matched unrelated donor as treatment for hematologic malignancy or MDS. * Age ≥ 1 year at the time that the informed consent document is signed. * Patients with acute leukemia must be in complete remission (defined as an M1 marrow -\<5% blasts- no evidence of extramedullary disease. Complete remissions without platelet recovery (CRp) will be considered remissions. * Planned GVHD prophylaxis with a calcineurin inhibitor and methotrexate per institutional standards. * Subject or parent/guardian must sign an informed consent document, and if appropriate, children must sign an assent document. Exclusion Criteria: * Patients who are to receive a non-myeloablative conditioning regimen. * Patients receiving another investigational drug for acute GVHD prevention during the conditioning regimen or a planned investigational drug for the first year after transplant (there are no restrictions on GVHD treatment). * Any medical or psychological condition or situation deemed by the Investigators to put the patient at increased risk of complications or non-compliance. * Patient with a secondary malignancy who would be otherwise eligible for study, but for whom remission from the primary disease cannot be conclusively confirmed or for whom the chance of relapse of the primary disease is significant. * Pregnancy (positive serum b-HCG) or breastfeeding. * Estimated glomerular filtration rate (GFR) of \< 50 mL/min/1.73m2. * Cardiac ejection fraction \< 50 (using M-Mode if assessment is done by Echocardiogram) * T bilirubin \> 2 × upper limit of normal or alanine aminotransferase (ALT) \> 4 × upper limit of normal or aspartate aminotransferase (AST) \> 4 x upper limit of normal unresolved veno-occlusive disease * Pulmonary disease with forced vital capacity (FVC), forced expiratory volume (FEV1) or diffusing capacity for carbon monoxide (DLCO) parameters \<45% predicted (corrected for hemoglobin) or requiring supplemental oxygen. Children who are developmentally unable to perform pulmonary function testing will be assessed solely on their need for supplemental oxygen. * Karnofsky performance score or Lansky Play-Performance Scale score \<80 * Human leukocyte antigen (HLA) antibody screen positive for HLA antibodies specific against the MSC products.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Children's Healthcare of Atlanta at Egleston

    Atlanta, Georgia, 30322, United States

  • Emory University

    Atlanta, Georgia, 30322, United States

  • Winship Cancer Institute of Emory University

    Atlanta, Georgia, 30322, United States

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