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Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)

NCT07650565 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 16

Last updated 2026-06-16

No results posted yet for this study

Summary

The objective of the study is to establish an in vitro model using iPSCs to test the hypotheses developed.

The primary objective is to generate, via the SAFE-IPS platform, 8 iPSC lines derived from blood samples taken from:

* Two patients with severe/diffuse SSc with multi-organ involvement (with anti-SCl-70 autoantibodies)
* Two of their healthy close relatives
* Two patients with uncomplicated SSc with localized involvement (with non-SCl-70 autoantibodies)
* Two of their healthy close relatives

These 8 cell lines will be differentiated by several teams at the FHU REGENHAB into:

* Immune cells (monocytes/macrophages, neutrophils, dendritic cells, B/T lymphocytes)
* Mesenchymal stromal cells
* Myocardial cells
* Skin cells (fibroblasts)
* Synovial cells
* Bronchial cells
* Endothelial cells

This project aims to map cellular and tissue heterogeneity using iPSC lines obtained from patients with both severe and mild SSc, employing single-cell RNA-seq under various pathological conditions, with and without autologous (or even heterologous) autoimmune stimulation. For example, the percentages of different cell types comprising a tissue in these various situations will be calculated. Comparisons will be made with control groups using healthy iPSC lines by recruiting healthy subjects with the same genetic profile and gender as the patients.

Conditions

  • Systemic Sclerosis (SSc)

Interventions

PROCEDURE

Blood Sample Collection

Collection of approximately 28 mL of blood from each participant to generate induced pluripotent stem cell (iPSC) lines for in vitro cellular and tissue modeling analyses.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • ARNAUD BOURDIN, MD · University Hospital, Montpellier

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2028-03-31
Completion
2028-03-31

Countries

  • France

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 NCT07650565 on ClinicalTrials.gov