Effect of PMSCs and Their Secretome for the Treatment of GvHD

NCT06469411 | Completed Phase 3 DMC

• 2 other identifiers: IRCT20201108049311N771647
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

GVHD

Keywords

Bone marrow; Mesenchymal stem cell; Secretome; Severe Graft-versus-host disease

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Intervention group

EXPERIMENTAL

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)

Control group

PLACEBO COMPARATOR

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%

Interventions

Secretome (set of substances released from the cell to its surroundings) of mesenchymal stem cells retrieved from the placenta (containing 400 microgram protein/ milliliter) BIOLOGICAL

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

Intervention group

4 cc distilled water dissolved in albumin 20% OTHER

Patients in the control arm received 6 doses of 4 cc distilled water dissolved in albumin 20% every week for 6 weeks

Control group

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with acute GvHD with fever and requiring hospitalization

You may not qualify if:

• Patients with sepsis

Sponsors & Collaborators

• Tabriz University of Medical Sciences: lead
• SCARM Institute, Tabriz, Iran: collaborator

Study Sites (1)

Abolfazl Barzegari

Tabriz, East Azerbaijan Province, 5166614756, Iran

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

Secretome

Condition Hierarchy (Ancestors)

Immune System Diseases

Intervention Hierarchy (Ancestors)

Metabolome; Metabolism

Study Officials

• Hossein Ghasemi Moghadam, MD

  Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• 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 CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: June 21, 2024
• Study Start: January 1, 2023
• Primary Completion: June 30, 2023
• Study Completion: January 30, 2024
• Last Updated: June 21, 2024

Record last verified: 2024-06

Locations

IR (1)