Clinical Trial

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

Study acronym: A-MUSE
Not Yet Recruiting Phase 2
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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.
Trial Details
NCT Number NCT07326033
Lead Sponsor University Hospital, Toulouse
Conditions Systemic Scleroderma
Enrollment 50 participants
Start Date 2026-01
Primary Completion 2028-04-30 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-08