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).
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)
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)
Single group
lipoaspiration
Procedure/SurgeryAdipose tissue harvest will be conducted by a surgeon under under local and intra-veinous sedation anesthesia. Once the patient is asleep and just before the laying of the operating drapes, the skin will be thoroughly disinfected, in order to avoid bacteriological contamination. Each entry point will be disinfected with betadine before and regularly during the procedure and will receive local anesthesia. The lipoaspiration sites will be infiltrated using a closed system, thanks to a Khoury canula. Adipose tissue will be harvested after waiting at least 5 minutes, in order to limit hematoma and excessive blood harvesting. A 3mm incision will be made then the tissue collection will be performed using a canula, manually, by gentle aspirations into a syringe then directly transferred into a connected sterile bag. The incision will be closed with 1 stitch of 6-0 absorbable and a paraffin gauze dressing. Then, patient will be awaken and transported to the recovery room.
Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)
DrugAutologous uncultured (AD-SVF) will be isolated by digestion and centrifugation of adipose tissue from lipoaspiration. Then, AD-SVF will be injected in 6 sites : * 2 for the accessory labial glands (0.5mL in the upper lip and 0.5mL in the lower lip) * 2 for the sublingual glands (0.5mL for each gland) * 2 for the inner face of cheeks (0.5mL for each side) The volume of injection will be of 3 mL containing 30 millions of AD-SVF viable nucleated cells for the total safety dose.
Intensity of adverse reactions at the injection site at day 1
1 day after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment
Intensity of adverse reactions at the injection site at day 3
3 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with phone assessment.
Intensity of adverse reactions at the injection site at day 7
7 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at day 14
14 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at day 15
15 days after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at month 1
1 month after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at month 3
3 months after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
Intensity of adverse reactions at the injection site at month 6
6 months after ADSVF injection, a subjective evaluation will be done by the patient of lip sensibility, pain, oedema or ecchymosis bleeding or haematoma, bleeding or haematoma, other event through an adapted report form with clinical assessment.
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