GVHD
Conditions
Keywords
Bone marrow, Mesenchymal stem cell, Secretome, Severe Graft-versus-host disease
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALSecretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter)
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
OTHER4 cc distilled water dissolved in albumin 20%
Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks
Sponsors
SCARM Institute, Tabriz, Iran
Tabriz University of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
This study was a triple-blinded study. In this way, the doctor introduced the patients to receive secretome/distilled water and was not aware of the grouping. Participating volunteers did not know about receiving secretome, distilled water, or other drugs. Secretome and distilled water were placed in similar and coded vials. In addition, the placebo (distilled water) was 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 were be also blinded.
Intervention model description
In this clinical trial study, 60 patients with GvHD, who were referred to Shahid Qazi Hospital in Tabriz, were randomly divided into 2 groups of 30 people, and the intervention and control groups received secretome and distilled water by injection, respectively. The method of blinding was tripleblinded and all the names and personal information of the patients was coded at the time of data collection and remain completely confidential.
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* Patients with acute GvHD with fever and requiring hospitalization
Exclusion criteria
* Patients with sepsis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liver involvement | At the beginning of the study and 6 weeks after the intervention | Measurement of Bilirubin level |
| Intestine condition | At the beginning of the study and 6 weeks after the intervention | Diarrhea volume measurement |
| Skin rash | At the beginning of the study and 6 weeks after the intervention | Determination of BSA percentage |
Countries
Iran
Outcome results
None listed