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IRCT20201108049311N7 IRCT 2023-09-28 Tabriz University of Medical Sciences Mesenchymal stem cells derived from the placenta and its secretions in the treatment of graft versus host disease GVHD Effect of mesenchymal stem cells derived from the placenta and their secretome for the treatment of GVHD: A triple-blinded randomized clinical trial 2023-08-23 anticipated 30 Complete https://irct.ir/trial/70990 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Thirty men and women with GVHD will be randomly assigned into two groups receiving intravenous secretome (15 people) or distilled water (15 people) using the random block method using blocks 4 and 6 through RAS (Random Allocation Software) and allocation ratio 1:1. In order to conceal the allocation, the secretome and distilled water will be placed in opaque vials numbered from 1 to 30. Participants will receive vials numbered 1 to 30 based on the order of entering the study. Preparing the vials and numbering them will be done based on the generated random sequence by a person not involved in the research, Blinding description: This study will be a triple-blinded study. In this way, the doctor will introduce the patients to receive secretome/distilled water and will not be aware of the grouping. Participating volunteers will not know about receiving secretome, distilled water, or other drugs. Secretome and distilled water will be placed in similar and coded vials. In addition, the placebo (distilled water) will be identical in appearance (shape and color), taste, and smell with secretome. In addition, due to the coding of patients and the lack of clarity in the grouping of patients, the data analyzer will be also blinded. 3 Graft versus host disease. Intervention 1: Intervention group: Recipient of 6 doses secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It will be produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks. Intervention 2: Control group: Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information.
public Dr. Abolfazl Barzegari
Stem Cell And Regenerative Medicine Institute,Tabriz University of Medical Sciences, Tabriz, Iran
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3336 7929 barzegari.abolfazl@gmail.com Tabriz University of Medical Sciences scientific Dr. Hussein Ghasemi Moghaddam
Hematology and Oncology Research Center, Shahid Ghazi Hospital, Daneshghah Ave., Tabriz
Tabriz Iran (Islamic Republic of) ۵۱۶۶۶۱۴۷۵۶ +98 41 3334 3811 dr.ghasemi621@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with acute GVHD with fever and requiring hospitalization 16 years 50 years Both Patients with sepsis D89.81 Graft-versus-host disease Treatment - Drugs Placebo Intervention group: Recipient of 6 doses secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) (It will be produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks Control group: Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks Skin rash. Timepoint: At the beginning of the study and 6 weeks after the intervention. Method of measurement: Examination of appearance (shape, color and texture of skin rash), determination of BSA percentage and staging based on it. Liver involvement. Timepoint: At the beginning of the study and 6 weeks after the intervention. Method of measurement: Measurement of Bilirubin level. Intestine condition. Timepoint: At the beginning of the study and 6 weeks after the intervention. Method of measurement: Diarrhea volume measurement. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences, Golgasht street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)