Fat stem cells injected into face could ease scleroderma mouth stiffness
NCT ID NCT07326033
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether injections of stem cells from donated fat tissue can help loosen mouth fibrosis in people with systemic scleroderma. Fifty adults with limited mouth opening will receive either stem cell or placebo injections around the mouth and be followed for 24 weeks. The main goal is to see if the treatment improves mouth function and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- allogeneic cultured adipose-derived mesenchymal stromal cells (AdMSC)
- What this could lead to
- If it works, this could offer a new way to reduce mouth tightness and improve eating, speaking, and oral care for people with scleroderma.
- What could go wrong
- This is an early phase 2 trial with only 50 participants, so results may not apply to everyone. The treatment involves injections and could cause side effects like pain or swelling.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
5 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Bordeaux Hospital
Bordeaux, France
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Dijon Hospital
Dijon, France
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Montpellier Hospital
Montpellier, France
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Nantes Hospital
Nantes, France
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Toulouse Hospital
Toulouse, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a One-Time cell therapy reset the immune system in autoimmune disease?
- New antibody drug aims to halt Scleroderma's grip
- Tiny particles may hold clues to autoimmune diseases
- Can a viagra drug heal scleroderma finger sores?
- Could a single infusion of supercharged immune cells tame incurable autoimmune diseases?
- New antibody drug firsekibart tested for scleroderma skin thickening