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Starting soon Phase 2

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

NCT07326033 · tracked via the Priya Life Science France tracker
Phase
Phase 2
Started
2026-01
Last updated
2026-01-08

Condition(s) studied

Systemic Scleroderma

Investigational drug(s) / intervention(s)

AdMSC →Placebo

AdMSC: At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks

Placebo: At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 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

Primary outcome measure(s)

  • Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) — Day 0, 12 weeks after injection
    the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12. An improvement of at least 5 points will be considered clinically significant

Trial sites (5)

FacilityCityRegionStatus
Bordeaux Hospital Bordeaux France
Dijon Hospital Dijon France
Montpellier Hospital Montpellier France
Nantes Hospital Nantes France
Toulouse Hospital Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07326033 on ClinicalTrials.gov ↗ ← All trials in France