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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

9 criteria

  • 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 trial?

15 criteria

  • 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
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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.

What is already known about the treatment

Adipose-derived mesenchymal stromal cells - A type of specialized stem cells harvested from fatty tissue and cultured in laboratory conditions for therapeutic use, administered through local injections into affected areas. This cellular therapy is currently being investigated in clinical trials for treating systemic scleroderma, particularly focusing on mouth fibrosis and related disabilities. The treatment works by utilizing the cells' natural ability to reduce inflammation and tissue scarring while promoting healing through the release of therapeutic molecules and growth factors. These cells belong to the category of advanced therapy medicinal products (ATMPs) and represent a promising approach in regenerative medicine for treating autoimmune and fibrotic conditions. Note: The description is based on the provided clinical trial information, where this cellular therapy is being studied specifically for orofacial fibrosis in systemic scleroderma patients.

Investigated diseases

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 detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-518516-39-00Protocol codeRC31/22/0258Estimated enrolment50 patientsSponsorCentre Hospitalier Universitaire De Toulouse

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