Stem cell infusions put to the test against a tough transplant complication
NCT ID NCT07826676
First seen Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time
Summary
Researchers are testing whether infusions of bone marrow-derived mesenchymal stem cells, called MesenCell, are safe for adults with moderate or severe chronic graft-versus-host disease that has not responded to steroids and other standard treatments. The trial enrolls up to 20 people aged 18 to 70 who developed this complication after an allogeneic stem cell transplant. Participants receive one to three intravenous infusions and are followed for a year to track side effects and any changes in disease activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bone marrow-derived mesenchymal stem cells (MesenCell)
- What this could lead to
- If it works, MesenCell infusions could offer a new way to calm chronic graft-versus-host disease when steroids and other standard drugs stop helping.
- What could go wrong
- This is a small Phase I safety trial, so researchers mainly want to know whether the infusions cause harm. Any sign of benefit would be early and would need testing in larger studies.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Age from 18 to 70 years; * Male or female sex; * Patients after allogeneic hematopoietic stem cell transplantation (any donor or stem cell source); * Presenting with moderate or severe chronic Graft versus host Disease refractory to treatment with corticosteroids and calcineurin inhibitors; * Patients who agree to participate in this study and who sign the Informed Consent Form. Exclusion Criteria: * Patients with any concomitant clinical condition that, in the physician's opinion, contraindicates the infusion of bone marrow-containing stem cells; * Pregnancy; * Patients (or their legal guardians) who do not agree to participate in this study or who do not sign the Informed Consent Form; * Patients with recurrent malignant neoplasm.
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Get notified about this study
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
4 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Hospital Erasto Gaertner
Curitiba, Paraná, 81520-060, Brazil
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Hospital Nossa Senhora das Graças
Curitiba, Paraná, 80810040, Brazil
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Hospital de Clínicas da Universidade Federal do Paraná
Curitiba, Paraná, 80060-150, Brazil
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Pontifícia Universidade Católica do Paraná
Curitiba, Paraná, 80215200, Brazil
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can adding rituximab improve remission in chronic GVHD?
- Can a new drug regimen beat the standard for stem cell transplant complications?
- Can a new pill tame the immune System's attack after stem cell transplants?
- One vitamin a pill before transplant: a new shield against a deadly complication?
- Can a new pill outperform standard care for a tough transplant complication?
- A gentler transplant may cure sickle cell and thalassemia — can the body accept donor cells?