Systemic SclerodermaPhase 2A-MUSENCT07326033
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
A Phase 2 study testing AdMSC in people with Systemic Scleroderma, run by University Hospital, Toulouse at 5 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- AdMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2026to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
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- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
Bordeaux Hospital
Bordeaux
Marie-Elise TRUCHETET, 0556794919, marie-elise.truchetet@chu-bordeaux.fr
Marie-Elise TRUCHETET
Dijon Hospital
Dijon
Martin NIVET, 04380293432, martin.nivet@chu-dijon.fr
Martin NIVET
Montpellier Hospital
Montpellier
Alexandre MARIA, 0467336733, a-maria@chu-montpellier.fr
Alexandre MARIA
Nantes Hospital
Nantes
Christian AGARD, 0240083379, christian.agard@chu-nantes.fr
Christian AGARD
Toulouse Hospital
Toulouse
Gregory PUGNET, 0561322077, pugnet.g@chu-toulouse.fr
Gregory PUGNET
About this study
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.
- Conditions
- Systemic Scleroderma
- Being tested
- AdMSC, Placebo
- Keywords
- Systemic Scleroderma, microstomia, oral health-related quality of life, oral pathology, regenerative medicine, allogenic cultured adipose-derived stromal cells
- Medical subject headings
- Scleroderma, Systemic, Microstomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdMSCDrug
At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks
PlaceboDrug
At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| AdMSC | Experimental | Patients will be standard of care (physiotherapy and daily self-administered exercises) and receive allogeneic AdMSC injection in the perioral (lips) region. Receives: Drug: AdMSC |
| Placebo | Placebo comparator | Patients will be standard of care (physiotherapy and daily self-administered exercises) and receive placebo injections in the perioral (lips) region Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS)
the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12. An improvement of at least 5 points will be considered clinically significant
Measured: Day 0, 12 weeks after injection
Secondary outcomes (15)
Safety of treatment
The safety throughout the course of the study (until week 24 since baseline) will be assessed by monitoring adverse events, serious adverse events and injection site reactions.
Measured: Day 0, 4, 12 and 24 weeks after injection
Efficacy on oral function by facial scanners
Efficacy on oral function is a composite measure derived from the change in maximum interincisal distance and mouth perimeter by facial scanners with digital acquisition of the patient's face in just a few seconds
Measured: Day 0, 4, 12 and 24 weeks after injection
Efficacy on orofacial handicap
Efficacy on orofacial handicap is a composite measure derived from change in Opening, Dryness and Aesthetic the 3 subscales of the MHISS
Measured: Day 0, 4, 12 and 24 weeks after injection
Patient satisfaction
the patients will be asked to fill in a simple questionnaire where their degree of satisfaction could be expressed by a composite measure derived by a semiquantitative score (unsatisfied, mildly/moderately satisfied, rather satisfied, and very satisfied), Scleroderma Health Assessment Questionnaire (sHAQ), Oral Health Assessment Tool (OHAT), Burden of Face Affected questionnaire (BOFA) and EQ-5D-5L
Measured: Day 0, 4, 12 and 24 weeks after injection
Oral habits and hygiene
Change in oral habits and hygiene is a composite measure derived from oral health and hygiene questionnaire
Measured: Day 0 and 24 weeks after injection
oral microbiota
Change in oral microbiota mesuared in unstimulated saliva
Measured: Day 0, 12 and 24 weeks after injection
Plaque index
Change in Plaque index (reflecting the ability to maintain oral hygiene)
Measured: Day 0, 12 and 24 weeks after injection
Change in decayed missing filled teeth
Change in decayed missing filled teeth (DMFT) index : a commonly used index validated by the WHO to assess oral status and the examinator simply counts the number of decayed, missing (due to caries or periodontal disease) and restored/filled teeth.
Measured: Day 0 and 24 weeks after injection
Change in mandibular tracking
Change Mandibular tracking is a composite measure derived from mandibular tracking and articular and neuro-muscular activity. Mandibular tracking and neuro-muscular activity will be measured with electrodes positioned in order to assess muscular activity at rest, muscle activity during mouth closure as well as during extreme movement of mouth opening and closing, mandibular propulsion and deduction. Muscle contraction synchronism and contraction efficacy will also be measured as well as the 3-dimensional innoclusion space and mandibular movement during swallowing
Measured: Day 0, 4, 12 and 24 weeks after injection
Posture by stabilometry
Change posture by stabilometry
Measured: Day 0, 12 and 24 weeks after injection
psycho-social aspects and oro-facial pains
Change in psycho-social aspects and oro-facial pains is a composite measure derived from EDAS21, Epworth and Combadazou-Destruhaut questionnaire
Measured: Day 0, 4, 12 and 24 weeks after injection
Rodnan skin score
Change in modified Rodnan skin score
Measured: Day 0, 12 and 24 weekds after injection
Dry mouth syndrome
Change in dry mouth syndrome is a composite measure derived from the change in Xerostomia Inventory questionnaire , in salivary flow, in the salivary pH and Salivary pH
Measured: Day 0, 4, 12 and 24 weeks after injection
Efficacy on aesthetics
the efficacy on aesthetics assessed by Standardized two-dimensional photographs or face scan
Measured: Day 0, 4 , 12 and 24 weeks after injection
Immunomonitoring of vascular and antifibrotic biomarkers
Immunomonitoring of vascular and antifibrotic biomarkers (V5. Endothelin-1, Endostatin, Endogline, Angiotensin I and II, Tie 1 and 2, VEGF, sICAM-1, sVCAM, E-selectin, CXCL4) measured in blood samples
Measured: Day 0 and 12 weekds after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study startJan 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326033
- Sponsor's protocol ID
- RC31/22/0258
- Other IDs
- 2024-518516-39-00
- Acronym
- A-MUSE
- Status last verified
- Dec 2025
- First submitted
- 4 Dec 2025
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
- ClinicalTrials.gov ID
- NCT07326033
- Acronym / sponsor ID
- A-MUSE / RC31/22/0258
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, microstomia, oral health-related quality of life, oral pathology, regenerative medicine, allogenic cultured adipose-derived stromal cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 8 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AdMSC | Experimental | Drug: AdMSCPatients will be standard of care (physiotherapy and daily self-administered exercises) and receive allogeneic AdMSC injection in the perioral (lips) region. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will be standard of care (physiotherapy and daily self-administered exercises) and receive placebo injections in the perioral (lips) region |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdMSCAt day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks | Drug | AdMSC |
| PlaceboAt day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks | Drug | Placebo |
Primary outcome
Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS)
Time frame: Day 0, 12 weeks after injection
the change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) between baseline and week 12. An improvement of at least 5 points will be considered clinically significant
15 secondary outcomes
Safety of treatment
Time frame: Day 0, 4, 12 and 24 weeks after injection
Efficacy on oral function by facial scanners
Time frame: Day 0, 4, 12 and 24 weeks after injection
Efficacy on orofacial handicap
Time frame: Day 0, 4, 12 and 24 weeks after injection
Patient satisfaction
Time frame: Day 0, 4, 12 and 24 weeks after injection
Oral habits and hygiene
Time frame: Day 0 and 24 weeks after injection
oral microbiota
Time frame: Day 0, 12 and 24 weeks after injection
Plaque index
Time frame: Day 0, 12 and 24 weeks after injection
Change in decayed missing filled teeth
Time frame: Day 0 and 24 weeks after injection
Change in mandibular tracking
Time frame: Day 0, 4, 12 and 24 weeks after injection
Posture by stabilometry
Time frame: Day 0, 12 and 24 weeks after injection
psycho-social aspects and oro-facial pains
Time frame: Day 0, 4, 12 and 24 weeks after injection
Rodnan skin score
Time frame: Day 0, 12 and 24 weekds after injection
Dry mouth syndrome
Time frame: Day 0, 4, 12 and 24 weeks after injection
Efficacy on aesthetics
Time frame: Day 0, 4 , 12 and 24 weeks after injection
Immunomonitoring of vascular and antifibrotic biomarkers
Time frame: Day 0 and 12 weekds after injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AdMSC in people with Systemic Scleroderma, run by University Hospital, Toulouse at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gregory PUGNET, MD, PHD (0561323954, pugnet.g@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) (time frame: Day 0, 12 weeks after injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.