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

NCT07326033•University Hospital, Toulouse

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (5)

Bordeaux Hospital

Bordeaux, France

Dijon Hospital

Dijon, France

Montpellier Hospital

Montpellier, France

Nantes Hospital

Nantes, France

Toulouse Hospital

Toulouse, France

Key Dates

Start Date

January 1, 2026

Primary Completion Date

April 30, 2028

Completion Date

July 31, 2028

Last Updated

January 8, 2026

Enrollment

ESTIMATED participants

Conditions

Systemic Scleroderma

Interventions

AdMSC

DRUG

Placebo

DRUG

Contacts

Gregory PUGNET, MD, PHD

CONTACT

0561323954 pugnet.g@chu-toulouse.fr

Charline DAGUZAN

CONTACT

0561778490 daguzan.c@chu-toulouse.fr

Diffuse Cutaneous Scleroderma (DSSc) SFDI Study

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Systemic SclerodermaDiffuse Cutaneous Scleroderma

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UNKNOWNNA

Evaluation of the Serum Soluble Fractalkine as a Biomarker of Pulmonary Fibrosis in Systemic Sclerosis

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TERMINATEDNA

Immunoadsorption in Patients With Severe Systemic Sclerosis

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 8, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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