Effect of PMSCs and Their Secretome for the Treatment of GvHD (GvHD)

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

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.

Study Overview

• Status: Completed
• Conditions: GVHD
• Intervention / 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); Other: 4 cc distilled water dissolved in albumin 20%

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • East Azerbaijan
    • Tabriz, East Azerbaijan, Iran, Islamic Republic of, 5166614756
      • Abolfazl Barzegari

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients with acute GvHD with fever and requiring hospitalization

Exclusion Criteria:

• Patients with sepsis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 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); 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
Placebo Comparator: Control group; 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 control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tabriz University of Medical Sciences
• Collaborators: SCARM Institute, Tabriz, Iran
• Investigators: Principal Investigator: Hossein Ghasemi Moghadam, MD, Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran; Study Director: Sepideh Zununi Vahed, PhD, Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Study Director: Babak Nejati, MD, Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran; Study Chair: Graciela Pavon-Djavid, PhD, Université Sorbonne Paris Nord, INSERM U1148, Laboratory for Vascular Translational Science, Cardiovascular Bioengineering, 99 Av. Jean-Baptiste Clément 93430 Villetaneuse, France

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): January 30, 2024

Study Registration Dates

• First Submitted: June 12, 2024
• First Submitted That Met QC Criteria: June 19, 2024
• First Posted (Actual): June 21, 2024

Study Record Updates

• Last Update Posted (Actual): June 21, 2024
• Last Update Submitted That Met QC Criteria: June 19, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Mesenchymal stem cell; Bone marrow; Secretome; Severe Graft-versus-host disease
• Other Study ID Numbers: IRCT20201108049311N7; 71647 (Other Grant/Funding Number: Tabriz University of Medical Sciences)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No