Cell Injections Tested for Mouth Stiffness in Systemic Scleroderma
Tests stem cell injections around the mouth in adults with systemic scleroderma, compared with placebo.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
Key facts
- Where
- Bordeaux, Dijon, Montpellier Cedex 5, Nantes, and Toulouse Cedex 9, FranceSee the 5 sites
- Phase
- Phase 2
Where in France
- Centre hospitalier Universitaire de BordeauxBordeaux, FranceTaking people
- Centre Hospitalier Universitaire de DijonDijon, FranceTaking people
- Centre Hospitalier Universitaire De MontpellierMontpellier Cedex 5, FranceTaking people
- Centre Hospitalier Universitaire de NantesNantes, FranceTaking people
- Centre Hospitalier Universitaire De ToulouseToulouse Cedex 9, FranceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Toulouse
- Trial code
- NCT07326033EU 2024-518516-39-00
- Record updated
- 8 January 2026
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
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.
Inclusion: 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,; Maximal mouth opening of less than 40 mm (distance between the dental arches); Patient must have provided written informed consent prior to enrolment,; Patient must be able to understand their requirements of participating in the protocol; Patient affiliated to a social security system.
Exclusion: 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",; Radio- or chemotherapy in progress,; 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,; 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; Patients with an indication for intensification by autologous HSCT (according to EBMT guidelines and national MATHEC-SFGMTC guidelines),; 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,.