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:
* Is MesenCell infusion safe in patients with corticosteroid-refractory chronic graft-versus-host disease? * Can MesenCell treatment improve the clinical response and disease control in these patients?
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.
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 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.
Single group
Mesenchymal Stem Cell Infusion
Biological/VaccineAdministration of Advanced Therapy Medicinal Product in patients with chronic GVHD
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.
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.
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.
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.
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.
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Pontifícia Universidade Católica do Paraná
Lead sponsor
Hospital Erasto Gaertner
Collaborator
Hospital de Clínicas da Universidade Federal do Paraná, Brazil
Collaborator
Hospital Nossa Senhora das Graças
Collaborator
Financiadora de Estudos e Projetos
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
