• Subcutaneous Injections of ASC to Heal Digital Ulcers in Patients With Scleroderma.

  NCT04356755

  RecruitingInterventionalPhase 2Updated Dec 31, 2025
• Subcutaneous Injection of Autologous Adipose Tissue-derived Stromal Vascular Fraction Into the Fingers of Patients With Systemic Sclerosis

  NCT02558543

  TerminatedInterventionalPhase 2Updated Mar 5, 2019
• Manufacturing of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells for Treatment of Severe Systemic Sclerosis

  NCT05947682

  Unknown statusInterventionalNot ApplicableUpdated Jul 17, 2023
• Phase I/II Randomized Clinical Trial of Allogeneic Adipose Tissue-derived Mesenchymal Stromal Cells Systemic Infusion in Severe Systemic Sclerosis

  NCT06722105

  Not yet recruitingInterventionalPhase 1Phase 2Updated Dec 9, 2024
• ADMSCs for the Treatment of Systemic Sclerosis

  NCT02975960

  CompletedInterventionalNot ApplicableUpdated Jan 25, 2018
• Assessment of the Subcutaneous Reinjection of Human Autologous Adipose-derived Stromal Vascular Fraction (Celution® System) in the Hands of Patients Suffering From Systemic Sclerosis

  NCT01813279

  CompletedInterventionalNot ApplicableUpdated Sep 1, 2014

ClinicalTrials.gov ID

NCT07326033

Lead Sponsor

University Hospital, ToulouseOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

50Estimated

Last Update Posted

Jan 8, 2026Actual

Start Date

Jan 2026Estimated

Primary Completion Date

Apr 30, 2028Estimated

Completion Date

Jul 31, 2028Estimated

Official Title

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

Brief 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.

• Systemic Scleroderma

• AdMSC
• Placebo

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

University Hospital, ToulouseOTHER

martin.nivet@chu-dijon.fr04380293432

a-maria@chu-montpellier.fr0467336733

christian.agard@chu-nantes.fr0240083379

pugnet.g@chu-toulouse.fr0561322077