Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia

Launched by ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE · May 4, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for patients with autoimmune xerostomia, a condition that leads to dry mouth due to an autoimmune disease. The researchers want to see if injecting a special type of fat-derived cells, taken from the patient's own body, into the saliva-producing glands can help improve saliva production. The main focus is on assessing how safe this treatment is and whether it causes any side effects within the first two weeks after the injection.

To participate in this study, you must be between 18 and 65 years old and have been diagnosed with autoimmune diseases like Gougerot-Sjögren syndrome. You should also have a certain level of dry mouth, as measured by a questionnaire. It's important that participants are not currently taking medications that could worsen dry mouth, and they should not have certain health conditions or be pregnant or breastfeeding. If you join, you'll receive the treatment and be monitored for any reactions for two weeks, helping researchers learn more about this potential new therapy.

Gender

ALL

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