About this trial
The main objective of this study is to evaluate the tolerance and safety of autologous adipose-derived stromal vascular fraction injected in accessory salivary glands for treatment of autoimmune xerostomia in terms of adverse reactions through day 14 (D14).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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)
Trial design
Treatments tested in this trial
- lipoaspiration
- Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)