SAFETY AND POTENTIAL EFFECT OF INNOVATIVE CELL-BASED THERAPY USING ADIPOSE-DERIVED STROMAL VASCULAR FRACTION IN PATIENTS WITH AUTOIMMUNE XEROSTOMIA

• Status: Not yet recruiting
• Trial end date: 2027-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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)

• Patient already enrolled in another study

• Under eighteen

• Person deprived of liberty

• Patient non-affiliated to the social security