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

Exclusion Criteria

• •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",
• •Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),
• •History of cancer in the last five years, except for successfully excised basal cell/squamous cell carcinoma, or successfully excised early melanoma of the skin. Subjects, who had a successful tumor resection or radiation or chemotherapy more than 5 years prior to inclusion and no recurrence, may be enrolled in the study,
• •Radio- or chemotherapy in progress,
• •Females who are pregnant or breastfeeding or plan to be or do so during the course of this study,
• •Women of childbearing potential (WOCBP) who are sexually active and unwilling to use an adequate birth control method,
• •Vulnerable patient (persons deprived of their liberty by judicial or administrative decision, persons undergoing psychiatric treatment, persons admitted to a health or social establishment for purposes other than research) according to article L1121-6 of the Public Health Code