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

ConditionXerostomia
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAssistance Publique Hopitaux De Marseille

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)

Treatment groups

18 Participants
are divided into 1 treatment group

Locations

This trial has no locations