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NCT Number: NCT07326033

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

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.

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Key information

Conditions

Systemic Scleroderma Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Connective Tissue Diseases Microstomia Mouth Abnormalities Mouth Diseases Scleroderma, Systemic Skin Diseases Skin and Connective Tissue Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bordeaux Hospital, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AdMSC

Drug

At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks

Placebo

Drug

At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks

Primary outcomes

  1. 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

Secondary outcomes

  1. Safety of treatment

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    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.

  2. Efficacy on oral function by facial scanners

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    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

  3. Efficacy on orofacial handicap

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    Efficacy on orofacial handicap is a composite measure derived from change in Opening, Dryness and Aesthetic the 3 subscales of the MHISS

  4. Patient satisfaction

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    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

  5. Oral habits and hygiene

    Time frame: Day 0 and 24 weeks after injection

    Change in oral habits and hygiene is a composite measure derived from oral health and hygiene questionnaire

  6. oral microbiota

    Time frame: Day 0, 12 and 24 weeks after injection

    Change in oral microbiota mesuared in unstimulated saliva

  7. Plaque index

    Time frame: Day 0, 12 and 24 weeks after injection

    Change in Plaque index (reflecting the ability to maintain oral hygiene)

  8. Change in decayed missing filled teeth

    Time frame: Day 0 and 24 weeks after injection

    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.

  9. Change in mandibular tracking

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    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

  10. Posture by stabilometry

    Time frame: Day 0, 12 and 24 weeks after injection

    Change posture by stabilometry

  11. psycho-social aspects and oro-facial pains

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    Change in psycho-social aspects and oro-facial pains is a composite measure derived from EDAS21, Epworth and Combadazou-Destruhaut questionnaire

  12. Rodnan skin score

    Time frame: Day 0, 12 and 24 weekds after injection

    Change in modified Rodnan skin score

  13. Dry mouth syndrome

    Time frame: Day 0, 4, 12 and 24 weeks after injection

    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

  14. Efficacy on aesthetics

    Time frame: Day 0, 4 , 12 and 24 weeks after injection

    the efficacy on aesthetics assessed by Standardized two-dimensional photographs or face scan

  15. Immunomonitoring of vascular and antifibrotic biomarkers

    Time frame: Day 0 and 12 weekds after injection

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Charline DAGUZAN

CONTACT

[email protected]

0561778490

Gregory PUGNET, MD, PHD

CONTACT

[email protected]

0561323954

Sponsors and collaborators

Lead sponsor

University Hospital, Toulouse

Other

Registry information

Acronym: A-MUSE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Jan 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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