NCT07326033

Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Scleroderma

Interventions

Type	Name	Description
DRUG	AdMSC	At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks
DRUG	Placebo	At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks

Timeline

• Start date: 2026-01-01
• Primary completion: 2028-04-30
• Completion: 2028-07-31
• First posted: 2026-01-08
• Last updated: 2026-01-08

Locations

5 sites across 1 country: France