Tissue models of systemic sclerosis using patient-derived iPSCs
Official title: Tissue Modeling in Systemic Sclerosis Using Induced Pluripotent Stem Cells (iPSCs)
Run by University Hospital, Montpellier · NCT07650565 · Data updated 2026-11-12
Researchers will create iPSC lines from people with systemic sclerosis, their healthy relatives, and test them across several cell types to see how the disease affects tissues in the lab.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 85 Years |
| Sex | All |
| Enrollment | 16 (estimated) |
| Sponsor | University Hospital, Montpellier Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Montpellier) |
| Status | Recruiting |
| Started | October 27, 2026 |
| Main results expected | April 2028 |
| Study ends | April 2028 |
| Registry record updated | October 29, 2026 |
| Trial ID | NCT07650565 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-85 with severe/diffuse SSc with multi-organ involvement, adults with localized SSc, and healthy first-degree relatives willing to donate blood for iPSC generation.
✕Probably not a fit
Patients unlikely to benefit directly are those whose disease is not related to the studied tissue pathways, or those not contributing biological samples.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
The study will generate eight iPSC lines from blood samples of patients with severe and localized systemic sclerosis and their healthy relatives. These cells will be differentiated into immune, stromal, cardiac, skin, synovial, bronchial, and endothelial cell types to build tissue models. Single-cell RNA sequencing will be used to map cellular and tissue heterogeneity under different pathological conditions. The goal is to illuminate disease mechanisms and identify potential therapeutic targets using patient-derived tissue models. This is an in vitro modeling approach rather than a clinical intervention.
Why it matters
Potential benefit: If successful, the work could reveal new insights into how systemic sclerosis affects different tissues and point to targets for future therapies.
How similar studies have gone: Prior iPSC-based tissue modeling studies have shown promise in recapitulating aspects of autoimmune disease biology and organ-specific pathology.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 18 and 85 years * Diagnostic criteria for the three groups: \> Severe SSc group: * Diagnosis of diffuse/severe systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria) * Known positivity of autoimmunity directed against Scl-70 \> Localized/non-complicated SSc group: * Diagnosis of systemic sclerosis by a physician for at least 12 months based on recommendations (according to ACR criteria) * Documentation of the absence of major vital organ involvement * Negative anti-Scl-70 autoantibodies but presence of other systemic sclerosis-related autoantibodies \> Healthy subjects group: * First-degree relative of a patient recruited in one of the systemic sclerosis groups (father, mother, brother, sister, adult child) * Absence of systemic autoimmune diseases Exclusion Criteria: * Other diseases that may affect erythroid progenitor cells (non-exhaustive: active cancer, hematological malignancy, chemotherapy targeting DNA) * Patient in an exclusion period determined by another protocol * Protected populations according to French public health law (pregnant or breastfeeding women; individuals deprived of liberty by judicial or administrative decision; adults under legal protection (any form of guardianship)) * Absence of informed consent * Not affiliated with a national health insurance system
Where it's running
-
University hospital Montpellier
Montpellier, France Recruiting
Study contacts
- Study coordinator: Arnaud Bourdin, Md
- Email: a-bourdin@chu-montpellier.fr
- Phone: 04 67 33 61 26
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.