Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
Xerostomia
About this trial
This is an interventional treatment trial for Xerostomia
Eligibility Criteria
Inclusion Criteria: Patients from 18 to 65 years. Patients suffering from xerostomia and autoimmune disease including : Gougerot-Sjögren disease according to AC/EULAR criteria and Secondary Gougerot-Sjögren syndrome related to systemic diseases (sclerodermia, rheumatoid arthritis, systemic lupus erythematosus...) Xerostomia visual scale (6-item visual analogue scale questionnaire) for assessment of salivary dysfunction : score ≥ 30/60 Informed consent to participate (with signature) Negative β -HCG test and effective contraception for women being able to get pregnant Affiliation to the social security system Exclusion Criteria: Medical history of head and neck neoplasia Recent (<3 months) medication inducing and aggravating xerostomia : Standard treatment with tricyclic antidepressant and/or antipsychotics Body Mass Index < 18 Active smoking (> 5 cigarettes a day) Active infectious disease and/or active viral serologies (HIV, HCV, HBV, HTLV I/II, TPHA/VDRL) Coagulation disorders including anticoagulant and antiplatelet treatment Any temporary or definitive contraindication due to any medical or surgical unstable condition Allergy to local anesthesia and/or albumin Pregnant or breastfeeding women Adult protected by the law (tutorship and curatorship) Patients already enrolled in another study Patients under 18 years of age Person deprived of liberty Patient non-affiliated to the social security
Sites / Locations
Arms of the Study
Arm 1
Experimental
Adult patients suffering from xerostomia and autoimmune disease
Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward : The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit; The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon; The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.