Effect of PMSCs and Their Secretome for the Treatment of GvHD

GVHD Clinical Trial

— GvHD  

Official title:

The Effect MSCs Derived From the Placenta and Their Secretome for the Treatment of GvHD: A Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06469411
• Other study ID #: IRCT20201108049311N7
• Secondary ID: 71647
• Status: Completed
• Phase: Phase 3
• Start date: January 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: June 2024
• Source: Tabriz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 30, 2024
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patients with acute GvHD with fever and requiring hospitalization

Exclusion Criteria:

• Patients with sepsis

Related Conditions & MeSH terms

• GVHD

Intervention

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)
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

Other:
• 4 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

Locations

Country	Name	City	State
Iran, Islamic Republic of	Abolfazl Barzegari	Tabriz	East Azerbaijan

Sponsors (2)

Lead Sponsor	Collaborator
Tabriz University of Medical Sciences	SCARM Institute, Tabriz, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver involvement	Measurement of Bilirubin level	At the beginning of the study and 6 weeks after the intervention
Primary	Intestine condition	Diarrhea volume measurement	At the beginning of the study and 6 weeks after the intervention
Primary	Skin rash	Determination of BSA percentage	At the beginning of the study and 6 weeks after the intervention