Not yet recruiting NCT07326033
Efficacy and Safety of Allogenic Cultured Adipose-derived Mesenchymal Stromal Cell Injections on MoUth Fibrosis and Handicap in Patients With Systemic sclEroderma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AdMSC, Placebo.
- Who it may be relevant to
- Registry conditions: Systemic Scleroderma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Drug AdMSC
At day 0, patients will have AdMSC injections in perioral region. Patients will be followed-up for 24 weeks - Drug Placebo
At day 0, patients will have placebo injections in perioral region. Patients will be followed-up for 24 weeks
Primary outcome measures
- Change in the Mouth Handicap in Systemic Sclerosis scale (MHISS) [Time frame: Day 0, 12 weeks after injection]
Secondary outcome measures (12)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
France · 5 centers
- Bordeaux Hospital — Bordeaux
- Dijon Hospital — Dijon
- Montpellier Hospital — Montpellier
- Nantes Hospital — Nantes
- Toulouse Hospital — Toulouse
Identifiers
NCT: NCT07326033 · RC31/22/0258 · 2024-518516-39-00