Graft vs Host Disease
Conditions
Interventions
This is a prospective, single-arm, open-label, phase I/II clinical trial. Eleven patients with steroid-refractory chronic graft-versus-host disease will receive an intravenous infusion, in a single do
Sponsors
Hospital de Clínicas da Universidade Federal do Paraná - HCUFPR
Pontifícia Universidade Católica do Paraná
Eligibility
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: Age from zero to 70 years; patients (or their parents) who agree to participate in this study and who sign the informed consent form; patients after allogeneic hematopoietic stem cell transplantation; classic chronic Graft-versus-host Disease or overlap syndrome, refractory to corticosteroid and calcineurin inhibitor treatment and/or interleukin 2 inhibitors. The refractory criteria will be worsening in three days, no improvement in seven days after the beginning of corticosteroid therapy, or no improvement after 21 days of the beginning of interleukin 2 inhibitors
Exclusion criteria
Exclusion criteria: Patients who have any concomitant clinical condition that contraindicates the infusion of mesenchymal stem cells, in the physician's opinion; patient with respiratory failure requiring mechanical ventilation; patients with relapsed malignant disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The expected primary outcome is safety in the use of mesenchymal stem cells obtained from related or unrelated HLA compatible or haploidentical donors for treatment of steroid-refractory chronic graft-versus-host disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| The expected secondary outcome includes the effectiveness of mesenchymal stem cells infusion for treatment of steroid-refractory chronic graft-versus-host disease. | — |
Countries
Brazil
Contacts
Public ContactCarmen Rebelatto
Pontifícia Universidade Católica do Paraná
Outcome results
None listed