Effect of PMSCs and Their Secretome for the Treatment of GvHD

Tabriz University of Medical Sciences

Status and phase: Completed; Phase 3

Conditions: GVHD

Treatments: Other: 4 cc distilled water dissolved in albumin 20%; 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)

Study type: Interventional

Funder types: Other

Identifiers

NCT06469411

71647 (Other Grant/Funding Number)

IRCT20201108049311N7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with acute GvHD with fever and requiring hospitalization

Exclusion criteria

• Patients with sepsis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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

Treatment:

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)

Control group

Placebo Comparator group

Description:

Recipient of 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks

Treatment:

Other: 4 cc distilled water dissolved in albumin 20%