Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
Condition(s) studied
Investigational drug(s) / intervention(s)
AdMSC: At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks
Placebo: At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks
Study summary
Orofacial manifestations and microstomia are a frequent complication in systemic sclerosis (SSc) with a major impact on oral hygiene, dental care and quality of life. Peri-oral injection of allogeneic cultured adipose-derived stromal cells constitutes a promising approach to treat scleroderma-induced mouth fibrosis where no alternative therapy is validated. The aim of this phase 2 study is to compare efficacy and safety of perioral injection of allogeneic cultured adipose-derived stromal cells (AdMSC) versus placebo to improve oro-facial fibrosis in patients with systemic sclerosis.
Eligibility
Primary outcome measure(s)
- Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) — Day 0, 12 weeks after injection
the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12. An improvement of at least 5 points will be considered clinically significant
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| Bordeaux Hospital | Bordeaux | France | |
| Dijon Hospital | Dijon | France | |
| Montpellier Hospital | Montpellier | France | |
| Nantes Hospital | Nantes | France | |
| Toulouse Hospital | Toulouse | France |
More University Hospital, Toulouse trials in France
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07326033 on ClinicalTrials.gov ↗ ← All trials in France