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Effect of PMSCs and Their Secretome for the Treatment of GvHD

NCT06469411 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-06-21

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • SCARM Institute, Tabriz, Iran

    collaborator OTHER_GOV

  • Tabriz University of Medical Sciences

    lead OTHER

Principal Investigators

  • Hossein Ghasemi Moghadam, MD · Stem Cell and Regenerative Medicine Institute, Tabriz University of Medical Sciences, Tabriz, Iran

  • Sepideh Zununi Vahed, PhD · Kidney Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

  • Babak Nejati, MD · Hematology and Oncology Research Center, Tabriz University of Medical Sciences, Tabriz, Iran

  • 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 Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-06-30
Completion
2024-01-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06469411 on ClinicalTrials.gov