A Phase 1 interventional study of Mesenchymal Stem Cell Infusion in Graft vs Host Disease and Mesenchymal Stem Cell Transplantation, sponsored by Pontifícia Universidade Católica do Paraná. Not yet recruiting at 4 sites in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by Pontifícia Universidade Católica do Paraná · Phase 1, Interventional, and Treatment
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Among 12 studies in Graft vs Host Disease with a site in Brazil — 4 open to participants now, 5 under way, 1 of them phase 3. Graft vs Host Disease · Brazil.
Among the 12 studies in Graft vs Host Disease with a site in Brazil, this one is the 10th largest by planned enrollment, is the only one that started in 2026, is the only one in phase 1, and was the 12th registered.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
Browse Graft vs Host Disease studies →4 of the 12 studies in Graft vs Host Disease with a site in Brazil are open now. Recruiting first, the newest first:
Instituto Nacional de Cancer, Brazil · Sites in Brazil
Ages 18–60
University of Sao Paulo General Hospital · Sites in Brazil
Ages 18–70
Hospital Israelita Albert Einstein · Sites in Brazil
Ages 1–75
A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →
Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 70 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 3 · Phase 2 7 · Phase 3 3 · Phase 4 2
First in 2002; this study’s year is marked. 1 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 20 is below the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Median enrollment 47 across the 12 interventional studies. Of the 6 that completed or were terminated, 2 (33%) have results posted.
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4 of 12 have an industry lead sponsor. The 10 most frequent:
Pontifícia Universidade Católica do Paraná is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Pontifícia Universidade Católica do Paraná has 1 study filed under Graft vs Host Disease — fewer than ten, so there is no comparison to draw.
1 of the studies in Graft vs Host Disease with a site in Brazil that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07014059GIANCARLO FATOBENEAutologous Serum Obtained by a Closed-Circuit Collection Device | 2027-02-01 |
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Among the 12 studies in Graft vs Host Disease with a site in Brazil, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The purpose of this Phase I clinical trial is to evaluate the safety and potential treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) that is refractory to corticosteroid treatment. The main questions it seeks to answer are:
Participants will receive one to three intravenous infusions of MesenCell, according to the study protocol and be followed for 12 months after the last MesenCell infusion.
This is a prospective, single-arm, open-label Phase I clinical trial designed to evaluate the safety and treatment response of bone marrow-derived mesenchymal stem cells (MesenCell) in adult patients with moderate or severe chronic graft-versus-host disease (cGVHD) refractory to corticosteroid treatment.
Approximately 20 participants will be enrolled in the study. Participants will receive one to three intravenous infusions of MesenCell at a dose of 2 × 10⁶ cells/kg, administered at seven-day intervals. The number of infusions will depend on the dose-escalation level to which each participant is assigned.
MesenCell will be administered in combination with standard treatment consisting of corticosteroids at a dose of 1 mg/kg/day and cyclosporine. Participants will undergo clinical and laboratory monitoring throughout the study to evaluate the safety of the intervention and the occurrence, frequency, severity, and causal relationship of adverse events following MesenCell infusion.
Treatment response will be assessed using standardized criteria for chronic graft-versus-host disease, including overall and organ-specific response. The study will also evaluate all-cause mortality, failure-free survival, and changes in corticosteroid and immunosuppressive medication use, including dose reductions, treatment discontinuation, and reduction in the number of immunosuppressive agents.
Participants will be followed for 12 months after administration of the last MesenCell dose. During this period, clinical assessments and review of medical records will be performed to monitor treatment response, disease progression, safety outcomes, need for additional systemic therapy, mortality, and changes in concomitant immunosuppressive treatment.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Allogeneic and autologous transplant
Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patient will receive 1 to 3 intravenous infusions of 2 × 10⁶/kg of Mesenchymal stem cells (MSCs) at 7 day intervals
Biological: Mesenchymal Stem Cell Infusion
Administration of Advanced Therapy Medicinal Product in patients with chronic GVHD
Also known as: Mesenchymal Stem Cell Transplantation
Number of Participants With Treatment-Related Adverse Events
Number of participants experiencing unexpected adverse events or adverse events considered probably or definitely attributable to MesenCell infusion within 30 days after the last dose. Adverse events will be classified according to the Common Terminology Criteria for Adverse Events (CTCAE) version 6.0 (2025). Grade 3 or higher events will be considered for toxicity assessment.
Time frame: 30 days after the last MesenCell infusion
Overall Treatment Response Rate
Percentage of participants with partial or complete overall response, according to the 2014 National Institutes of Health (NIH) Consensus Development Project response criteria for chronic graft-versus-host disease.
Time frame: 6 months after treatment initiation
Change in Overall Response
Change from baseline in overall severity according to the 2014 National Institutes of Health (NIH) Consensus Development Project criteria. Overall severity is classified as mild, moderate, or severe based on the number of organs involved and the severity scores assigned to each affected organ. Mild disease is defined as involvement of 1 or 2 organs, with no organ scoring more than 1, and a lung score of 0. Moderate disease is defined as involvement of 3 or more organs with no organ scoring more than 1, or at least 1 non-lung organ with a score of 2, or a lung score of 1. Severe disease is defined as at least 1 organ with a score of 3 or a lung score of 2 or 3.
Time frame: From baseline through 12 months after treatment initiation
Change in Organ-Specific Response Scores
Change from baseline in organ-specific response scores for the skin, mouth, eyes, gastrointestinal tract, liver, lungs, joints and fascia, and genital tract. Each organ is scored on an ordinal scale from 0 to 3 according to predefined clinical or laboratory criteria specific to the affected organ. A score of 0 indicates no signs or symptoms, while a score of 3 indicates severe involvement. Higher scores indicate greater disease severity and a worse outcome.
Time frame: From baseline through 12 months after treatment initiation
All-cause mortality
Time from the first MesenCell infusion to death from any cause. Survival will be estimated at 6 and 12 months and as median overall survival during the follow-up period. Participants who remain alive will be censored at the last contact.
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Failure-Free Survival
Time from the first MesenCell infusion to the first occurrence of treatment failure, defined as relapse of the underlying disease, progression or reactivation of chronic graft-versus-host disease, or death from any cause. Relapse of the underlying disease will be assessed primarily by complete blood count, with bone marrow aspirate performed when relapse is suspected based on blood count findings. Reactivation of chronic graft-versus-host disease will be assessed at each medical visit according to the NIH organ scoring criteria. Participants without treatment failure will be censored at the last contact. Failure-free survival will be estimated at 6 and 12 months.
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Reduction in Corticosteroid Therapy
Percentage of participants who have a reduction in corticosteroid dose compared with baseline during the follow-up period. Corticosteroid dose will be assessed using medical records, prescription data, and clinical follow-up.
Time frame: From treatment initiation through 12 months after the last MesenCell infusion
Discontinuation of Immunosuppressive Therapy
Percentage of participants who discontinue systemic immunosuppressive therapy during the follow-up period. Immunosuppressive therapy use and discontinuation will be determined from medical records, prescription data, and clinical follow-up.
Time frame: From treatment initiation through 12 months after the last MesenCell infusion
Time to Best Overall Response
Time from the first MesenCell infusion to the first documentation of the best overall response according to the 2014 National Institutes of Health (NIH) Consensus Development Project response criteria for chronic graft-versus-host disease.
Time frame: From the first MesenCell infusion through 12 months after the last MesenCell infusion
Plan to share: No
Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.
Of 39 non-industry phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 49 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 69. This study's planned 23 months is below that.
Counting every sponsor, half of 49 studies reached it within 47 months; a quarter within 24 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Mesenchymal Stem Cell
Pontifícia Universidade Católica do Paraná