A Phase 3 interventional study of Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) and 4 cc distilled water dissolved in albumin 20% in GVHD, sponsored by Tabriz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 16 Years to 50 Years. Per ClinicalTrials.gov, last updated 2024-06-21.
Sponsored by Tabriz University of Medical Sciences · Phase 3, Interventional, and Treatment
In this clinical trial study, 60 patients with GvHD referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 intervention and control groups (n= 30 in each) that received secretome and distilled water by injection, respectively. The method of blinding was triple-blinded and all the names and personal information of the patients were coded at the time of data collection and remained completely confidential.
This study is a safety, feasibility, and efficacy trial that was conducted on eligible GvHD patients with the diagnosis of expert doctors after obtaining permission from the respected ethics committee and registering the trial at the Iranian Trial Registration Center. During the phone call, while stating the title and objectives of the study, the entry and exclusion criteria were checked. If they are eligible, they were asked to attend the Ghazi Hospital if they wish to participate in the study. In the face-to-face meeting, the objectives of the research were fully explained and the study criteria were re-examined. The written informed consent was obtained and questionnaires fulfilled three times which include personal-social characteristics, medical characteristics, appetite questionnaire, 24-hour food record (Food record), and family members. At the beginning of the study, 50 cc of blood was used to collect serum and to culture and condition mesenchymal stem cells. 200 men with GvHD were randomly assigned using random block method using blocks of 4 and 6 and RAS (Random Allocation Software) and allocation ratio 1:1 to two groups receiving intravenous secretome with The first protocol (30 people) and receiving the mesenchymal stem cells secretome of the second protocol (30 people) were allocated and they received the skin spray for 1 year. Participants in the first protocol group at the beginning of the study, day 3, end of the week, the end of the second week, and the end of the month 5 times and in the second protocol group at the beginning of the study, skin spray were done. The secretome of both groups was the same.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
This study's enrollment of 60 is above the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
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Exclusion Criteria:
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 was produced through the cell culture from the placenta in the laboratory) 4 cc dissolved in albumin 20% every week for 6 weeks
Biological: Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)
Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
Other: 4 cc distilled water dissolved in albumin 20%
Patients in the intervention arm received 6 doses of secretome of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) 4 cc dissolved in albumin 20% every week for 6 weeks
Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
Liver involvement
Measurement of Bilirubin level
Time frame: At the beginning of the study and 6 weeks after the intervention
Intestine condition
Diarrhea volume measurement
Time frame: At the beginning of the study and 6 weeks after the intervention
Skin rash
Determination of BSA percentage
Time frame: At the beginning of the study and 6 weeks after the intervention
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Tabriz University of Medical Sciences