se of mesenchymal stromal cells for Graft-versus-host disease after stem cell transplantatio

Phase 1

Terminated

• Conditions: Graft vs Host Disease; T86.0

• Registration Number: RBR-7s99ksf
• Lead Sponsor: Hospital de Clínicas da Universidade Federal do Paraná - HCUFPR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-05-01
• Study Start: 2022-08-05
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Terminated
• Sex: Not specified
• Target Recruitment: Not specified

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

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

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The expected secondary outcome includes the effectiveness of mesenchymal stem cells infusion for treatment of steroid-refractory chronic graft-versus-host disease.<br>