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IRCT2014072618603N1 IRCT 2015-10-26 Vice chancellor of research, Shiaz Univeisity of Medical Sciences Adult Human Mesenchymal Stem Cells for the treatment of Steroid-Refractory Acute Graft-versus-Host Disease Adult Human Mesenchymal Stem Cells for the treatment of Steroid-Refractory Acute Graft-versus-Host Disease 2016-04-20 anticipated 20 Complete https://irct.ir/trial/16825 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 3 Graft-versus-host reaction or disease. 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. Intervention 2: Control group: Patients who just receive standard of care include steroid therapy such as methylprednisolone 2 mg/kg daily.
public Dr. Reza Vojdani
Nemazee hospital, shiraz, Iran
Shiraz Iran (Islamic Republic of) +98 71 3628 1563 vojdanir@sums.ac.ir Institute of Hematology -Oncology, Nemazee Hospital, Shiraz, Iran scientific Dr. Reza Vojdani
52, West Hedayat street, Shiraz
Shiraz Iran (Islamic Republic of) +98 71 3234 0767 vojdanir@sums.ac.ir Institute of Hematology -Oncology, Nemazee Hospital, Shiraz, Iran Iran (Islamic Republic of) 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) 2 years 60 years Both T86.0 Graft-versus-host reaction or disease 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 Control group: Patients who just receive standard of care include steroid therapy such as methylprednisolone 2 mg/kg daily. 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. 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. Vice chancellor of research, Shiaz Univeisity of Medical Sciences Approved 2015-09-05 Ethics committee of Shiraz University of Medical Sciences 7th floor, Vice chancellery for research affairs, Shiraz University of Medical Sciences, Zand avenue, Shiaz, Iran Shiraz Iran (Islamic Republic of)