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Treatment With Human Umbilical Cord-derived Mesenchymal Stromal Cells in Systemic Sclerosis

NCT04356287 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-02-03

No results posted yet for this study

Summary

The purpose of this study is to test the safety and efficacy of Umbilical Cord-derived Mesenchymal Stromal Cells (UCMSC) for the treatment of Systemic Sclerosis (SSc).

Conditions

  • Sclerosis, Systemic
  • Mesenchymal Stem Cells

Interventions

BIOLOGICAL

UCMSC

Each infusion will consist of 1 million MSC/kg suspended in 50 mL of PlasmaLyte A.

OTHER

Placebo

Each infusion will consist of 50 mL of PlasmaLyte A.

Sponsors & Collaborators

  • Medical University of South Carolina

    collaborator OTHER

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    collaborator OTHER

  • Université de Montréal

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    collaborator OTHER

  • University Paris 7 - Denis Diderot

    collaborator OTHER

  • Marie Hudson, MD

    lead OTHER

Principal Investigators

  • Marie Hudson, MD · Sir Mortimer B. Davis - Jewish General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-05
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • Canada

Study Locations

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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 NCT04356287 on ClinicalTrials.gov