Phase 1Not yet recruiting

Use of Bone Marrow Stem Cells (MesenCell) for the Treatment of Patients With Chronic Graft-versus-host Disease

Use of Bone Marrow-Derived Mesenchymal Stem Cells (Mesencell) for the Treatment of Patients Undergoing Hematopoietic Progenitor Cell Transplantation Who Developed Refractory Moderate or Severe Chronic Graft-versus-Host Disease: A Phase I Clinical Trial

Sponsor
Pontifícia Universidade Católica do Paraná (Academic or other)
Enrolment
20 planned
Conditions
Graft vs Host Disease; Mesenchymal Stem Cell Transplantation
Interventions
Mesenchymal Stem Cell Infusion
Ages
adults, older adults
Registry
NCT07826676, RBR-22jd7g5

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Number of Participants With Treatment-Related Adverse Events

History

  1. Study completion expected

  2. Primary completion expected

  3. Started

  4. Registered

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