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.
Male or female patient ≥18 years of age,
Patient with systemic scleroderma according to the 2013 ACR/EULAR classification criteria,
Mouth Handicap in Systemic Sclerosis Scale (MHISS) score more than or equal to 20 (0-48),
Rodnan skin score on the face more than or equal to 1,
Patient participating in a clinical trial or having participated in a clinical trial within the previous 3 months,
Injection of botulinum toxin within 4 weeks prior to "inclusion visit",
Patient who underwent autologous hematopoietic stem cell transplantation (HSCT) within less than 1 year,
Local active labial herpes virus within 1 week prior to "inclusion visit",