Graft-versus-host reaction or disease. Graft-versus-host reaction or disease
Conditions
Interventions
Control group: Patients who just receive standard of care include steroid therapy such as methylprednisolone 2 mg/kg daily.
Intervention 1: Intervention group: Patients who receive standard of care plus intravenous injection of 1 ± 0.5 × 106 cells/ kg recipient body weight of allogenic adult human mesenchymal stem cell. In
Treatment - Other
Treatment - Drugs
Intervention group: Patients who receive standard of care plus intravenous injection of 1 ± 0.5 × 106 cells/ kg recipient body weight of allogenic adult human mesenchymal stem cell
Sponsors
Vice chancellor of research, Shiaz Univeisity of Medical Sciences
Eligibility
Sex/Gender
All
Age
2 Years to 60 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Reza Vojdani
Institute of Hematology -Oncology, Nemazee Hospital, Shiraz, Iran
Outcome results
None listed