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IRCT20140818018842N40 IRCT 2024-06-09 Tehran University of Medical Sciences Placenta-derived mesenchymal stem cells and placenta-derived mesenchymal stem cells exosomes in the treatment of acute GvHD Evaluaing the safety and effectiveness of intravenous infusion of placenta-derived mesenchymal stem cells and placenta-derived mesenchymal stem cell exosomes in steroid-resistant acute GvHD patients; Phase I and II clinical trial 2024-06-21 anticipated 60 Complete https://irct.ir/trial/77149 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study,In order to reduce bias, randomization is done by online randomization method by a statistician. the randomization process was conducted using the Clinical Trial Randomization Tool provided by the National Cancer Institute (NCI) https://ctrandomization.cancer.gov/ to assign 60 participants to 3 groups: Group A, B, & C. This randomization procedure was performed in a double-blind manner, ensuring that both investigators and participants remained unaware of the group assignments, and the randomization process was blinded. Then, in order to reduce to zero the possibility of interfering in the selection of the intervention group by the researcher, 60 envelopes (containing number 1 to 60 and intervention group A, B, or C) were prepared at the time of the start of the study based on the order of entry of the eligible participants into the study, randomly from one of the envelopes was sent to The order will be opened and the placement of the patient in the intervention group will be determined, Blinding description: Patients will be placed in one of three study groups and will be blinded to which study group they will be placed in. The drug is injected to the patient by the researcher. And the nurses will be blind to which study group they are included in. 1-2 Acute GvHD. Intervention 1: Intervention group: intravenous injection of a solution containing mesenchymal stem cells obtained from the human placenta is performed in 20 patients with acute graft-versus-host disease. Mesenchymal stem cells are injected at the rate of 1 million cells per kilogram of body weight in 200 cc of normal saline and 4 times at intervals of 3 days in patients. Mesenchymal stem cells are obtained in the clean room of Viraselul company and necessary quality control tests are performed on the final product. Treatment follow-up is done in the first and second week and in the first, third and sixth months after the injection. Intervention 2: Intervention group: intravenous injection of a solution containing exosome of mesenchymal stem cells obtained from human placenta is performed in 20 patients with acute graft-versus-host disease. Exosome of mesenchymal stem cells is injected in the amount of 1.2 x 10^12 exosomes in 50 cc of normal saline and 4 times with an interval of every 3 days in patients. Mesenchymal stem cells are obtained in the clean room of Viraselul company and necessary quality control tests are performed on the final product. Treatment follow-up is done in the first and second week and in the first, third and sixth months after the injection. Intervention 3: Control group: Ruxolitinib in 20 patients, NanoAlvand company, 5 mg twice daily, oral, 0 to 28 days after injection. Yes - There is a plan to make this available What will be shared: Clinical study report in the form of an article When: The access period starts 6 months after the results are published To whom: Researchers working in academic and scientific institutions Conditions: Access to data and by request via email Where to obtain: bajouri.md@gmail.com How to obtain: Within one month after the request, your request will be reviewed and the result will be announced. Comments:
public Maryam Barkhordar
Kargar-e-Shomali Ave.
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8800 4140 barkhordarm.n@gmail.com Tehran University of Medical Sciences scientific Maryam Barkhordar
Kargar-e-Shomali Ave.
Tehran Iran (Islamic Republic of) 1411713131 +98 21 8800 4140 barkhordarm.n@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Acute aGvHD grade II-IV according to MAGIC criteria and steroid resistant according to EBMT-NIH-CIBMTR A patient who underwent allogeneic HSCT with the following conditions: HLA-matched donor (MRD), HLA-mismatched donor (MUD), unrelated cord blood (UCB), haploidal donor 12 years 65 years Both Positive serology for hepatitis B, hepatitis C and AIDS virus or fungal infection Patients with penicillin and/or gentamicin allergy or known allergy to cow or pork products Participants with uncontrolled diseases including persistent or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness or specific social situations that limit compliance with study requirements Any condition that, in the investigator's judgment, interferes with full participation in the study, including the administration of study medication or participation in required study visits, or poses a significant risk to the participant, or interferes with the interpretation of study data Transplant recipient for solid tumor Diagnosis of Sinus Obstructive Syndrome (SOS) or Venous Obstructive Disease, at any time of study with appropriate tests Pregnancy and breastfeeding D89.81 Graft-versus-host disease Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: intravenous injection of a solution containing mesenchymal stem cells obtained from the human placenta is performed in 20 patients with acute graft-versus-host disease. Mesenchymal stem cells are injected at the rate of 1 million cells per kilogram of body weight in 200 cc of normal saline and 4 times at intervals of 3 days in patients. Mesenchymal stem cells are obtained in the clean room of Viraselul company and necessary quality control tests are performed on the final product. Treatment follow-up is done in the first and second week and in the first, third and sixth months after the injection. Intervention group: intravenous injection of a solution containing exosome of mesenchymal stem cells obtained from human placenta is performed in 20 patients with acute graft-versus-host disease. Exosome of mesenchymal stem cells is injected in the amount of 1.2 x 10^12 exosomes in 50 cc of normal saline and 4 times with an interval of every 3 days in patients. Mesenchymal stem cells are obtained in the clean room of Viraselul company and necessary quality control tests are performed on the final product. Treatment follow-up is done in the first and second week and in the first, third and sixth months after the injection. Control group: Ruxolitinib in 20 patients, NanoAlvand company, 5 mg twice daily, oral, 0 to 28 days after injection Adverse events. Timepoint: day of injection, 1 and 2 weeks, 1, 3 and 6 months after the first injection. Method of measurement: History and clinical examination based on common terminological criteria for adverse events. Complete response rate. Timepoint: Day of injection, 1 and 2 weeks, 1, 3 and 6 months after the first injection. Method of measurement: Clinical examination. Total survival rate. Timepoint: 0 to 6 months. Method of measurement: Clinical evaluation. Tehran University of Medical Sciences Approved 2024-04-06 Ethic committee of Hematology- Oncology and cell therapy Research Institute, Tehran University of Me Shariati Hospital, Jalal-e-Al-e-Ahmad Hwy Tehran Tehran Iran (Islamic Republic of)