Adult Human Mesenchymal Stem Cells for the treatment of Steroid-Refractory Acute Graft-versus-Host Disease

Phase 3

• Conditions: Graft-versus-host reaction or disease.; Graft-versus-host reaction or disease

• Registration Number: IRCT2014072618603N1
• Lead Sponsor: Vice chancellor of research, Shiaz Univeisity of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 February 2018

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

recipients of allogeneic hematopoietic stem cell transplantation; patients with refractory acute graft versus host disease; subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study Exclusion criteria:
any abnormality in a vital sign (heart rate, respiratory rate, or blood pressure); patients with any conditions not suitable for the trial (investigators' decision)

Exclusion Criteria

Not provided

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The efficacy of treatment for refractory acute graft versus host disease. Timepoint: 1, 4, 7, 14, 21, 28 days and 6 months after end of treatment. Method of measurement: The response criteria include complete response, part response, stable disease and progressive disease. complete response: acute graft versus host disease symptoms and signs disappear; part response: acute graft versus host disease symptoms and signs improve; stable disease: acute graft versus host disease symptoms and signs remain (without improvement or deterioration); progressive disease: acute graft versus host disease symptoms and signs deteriorate.

Secondary Outcome Measures

Name	Time	Method
Acute toxic side effects of mesenchymal stem cells treatment. Timepoint: 1, 4, 7, 14, 21, 28 days after end of the treatment. Method of measurement: To asses acute toxicity principally involves the heart, liver and kidney and possible infections by clinical presentation and paraclinical evaluations.;Late toxic side effects of mesenchymal stem cells treatment. Timepoint: 6 months after end of the treatment. Method of measurement: To asses late toxic side effects involves principally the development of secondary tumors, relapse of the primary disease and chronic graft versus host disease during 6 months of study by clinical presentation and paraclinical evaluations.