Study of adipose-derived mesenchymal stem cell injections to treat mouth fibrosis in patients with systemic scleroderma

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What is this study about?

This clinical trial focuses on patients with Systemic Scleroderma, a condition that causes hardening and tightening of the skin and connective tissues, particularly affecting the mouth and face area. The study aims to evaluate the effectiveness and safety of allogenic adipose-derived mesenchymal stem cells (known as CellReady) when injected into the affected areas of the mouth and face.

The treatment involves injections of stem cells derived from fatty tissue, combined with sodium chloride solution and albumin. These injections are intended to help reduce mouth fibrosis (tissue hardening) and improve mouth function in people with systemic scleroderma. The study will measure how well the treatment works by assessing changes in mouth movement and daily activities like eating and speaking.

Participants will receive the treatment and be monitored for 24 weeks. During this time, doctors will track various aspects of mouth function, including the ability to open the mouth, overall oral health, and any changes in facial tissue. They will also monitor the safety of the treatment by checking for any side effects or reactions at the injection sites.

1 Initial assessment and baseline measurements

Your mouth condition will be evaluated using the MHISS scale (a measure of mouth-related difficulties)

Medical staff will measure your maximum mouth opening between dental arches

Basic health measurements and blood samples will be collected

2 Treatment administration

You will receive injections containing adipose-derived stem cells (cells derived from fat tissue)

The treatment includes a combination of sodium chloride solution, stem cells, and albumin

The medications will be administered through injection

3 4-week follow-up

Your mouth opening and overall condition will be evaluated

You will complete questionnaires about your satisfaction and quality of life

Medical staff will assess any dry mouth symptoms

4 12-week evaluation

The main assessment of treatment effectiveness will take place

Your MHISS score will be measured again to evaluate improvement

Additional measurements of mouth opening and facial skin condition will be performed

Blood samples will be collected for analysis

5 24-week final assessment

Final evaluation of your mouth condition and overall health status

Complete set of measurements including mouth opening and skin assessment

Final blood samples will be collected

Dental x-ray will be performed

Final questionnaires about your satisfaction and quality of life

Who Can Join the Study?

Must be at least 18 years old
Must be diagnosed with systemic scleroderma according to specific medical criteria (ACR/EULAR 2013)
Must have a score of 20 or higher on the Mouth Handicap in Systemic Sclerosis Scale (MHISS), which measures difficulty in mouth movement and function
Must have a Rodnan skin score of 1 or higher on the face (this measures skin thickness)
Must have limited mouth opening – less than 40 millimeters between upper and lower teeth when opening the mouth as wide as possible
Must sign a written consent form showing agreement to participate in the study
Must be able to understand and follow study requirements
Must be registered with a social security system
Both men and women can participate

Who Cannot Join the Study?

Active infections or ongoing treatment with antibiotics
History of cancer in the past 5 years
Severe heart problems or uncontrolled heart disease
Pregnant women or those planning pregnancy during the study period
Breastfeeding women
Participation in another clinical trial in the past 30 days
Known allergies to study medications or their components
Severe kidney disease (problems with kidney function)
Severe liver disease (problems with liver function)
Autoimmune diseases other than systemic scleroderma
Mental health conditions that could interfere with following study procedures
Drug or alcohol abuse within the past year
Unable to provide informed consent
Unable to follow study procedures or attend scheduled visits
Any condition that, in the opinion of the study doctor, makes participation unsafe

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France
Oncopole Claudius Regaud	Toulouse	France

Other Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Centre Hospitalier Universitaire De Nantes	Nantes	France
Cakpbz Hmlubmnlkdn Uplwmuamnovzy Di Diykf	Dijon	France

Trial status

Country	Status	Recruitment Start
France	Not yet recruiting	01.09.2025

Trial locations

Investigated drugs:

Adipose-derived mesenchymal stromal cells (ADSC) are cells obtained from fat tissue of healthy donors. These cells are specially processed and cultured in a laboratory to be used as a treatment. When injected into the mouth and face area, these cells may help reduce scarring and stiffness (fibrosis) that occurs in patients with systemic scleroderma. The cells work by potentially reducing inflammation and promoting tissue healing. This is considered a type of cell therapy, where living cells are used as a therapeutic treatment.

Systemic Scleroderma – A chronic autoimmune disease that causes hardening and tightening of the skin and connective tissues. The condition begins with inflammation, followed by gradual tissue hardening (fibrosis) that can affect the skin, blood vessels, and internal organs. The disease typically starts with skin changes in the hands and face, causing the skin to become tight and shiny. In the orofacial area, it can lead to reduced mouth opening, difficulty in performing oral hygiene, and changes in facial appearance. The hardening process can also make facial expressions more difficult and affect the ability to eat and speak normally.

Trial ID:

2024-518516-39-00

Protocol code:

RC31/22/0258

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of adipose-derived mesenchymal stem cell injections to treat mouth fibrosis in patients with systemic scleroderma

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?