Clinical trial NCT05857358: Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia
Official title: Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Xerostomia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2023-05-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed description: Autoimmune xerostomia is a disabling condition affecting mostly patients suffering from Sjögren's disease, systemic lupus erythematosus, rheumatoid arthritis and systemic xerostomia.

Local therapies and systemic drug treatments (picarpine) remain the gold standards but have limited effects upon salivary flow action and many adverse effects.

Stem cell therapies and notably adipose tissue-derived stromal cells have shown promising potential for tissue repair. Autologous uncultured adipose-derived stromal vascular fraction (AD-SVF) is recognized as an easily accessible (by a standard lipoaspiration to obtain adipose tissue, from which AD-SVF are isolated by centrifugation), safe and well tolerated source of cells with angiogenic, anti-inflammatory, immunomodulatory and regenerative properties.

The purpose of our AD-SVF phase I trial is to evaluate, first the tolerance of autologous AD-SVF cells locally injected in the oral cavity and second their capability to improve the salivary function.

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

Primary outcomes:
measure: Intensity of adverse reactions at the injection site at day 1
timeFrame: 1 day
measure: Intensity of adverse reactions at the injection site at day 3
timeFrame: 3 days
measure: Intensity of adverse reactions at the injection site at day 7
timeFrame: 7 days
measure: Intensity of adverse reactions at the injection site at day 14
timeFrame: 14 days
measure: Intensity of adverse reactions at the harvesting site at day 1
timeFrame: 1 day
measure: Intensity of adverse reactions at the harvesting site at day 3
timeFrame: 3 days
measure: Intensity of adverse reactions at the harvesting site at day 7
timeFrame: 7 days
measure: Intensity of adverse reactions at the harvesting site at day 14
timeFrame: 14 days
Secondary outcomes:
measure: Intensity of adverse reactions at the injection site at day 15
timeFrame: 15 days
measure: Intensity of adverse reactions at the injection site at month 1
timeFrame: 1 month
measure: Intensity of adverse reactions at the injection site at month 3
timeFrame: 3 months
measure: Intensity of adverse reactions at the injection site at month 6
timeFrame: 6 months
measure: Intensity of adverse reactions at the injection site at month 7
timeFrame: 7 months
measure: Intensity of adverse reactions at the harvesting site at day 15
timeFrame: 15 days
measure: Intensity of adverse reactions at the harvesting site at month 1
timeFrame: 1 month
measure: Intensity of adverse reactions at the harvesting site at month 3
timeFrame: 3 months
measure: Intensity of adverse reactions at the harvesting site at month 6
timeFrame: 6 months
measure: Intensity of adverse reactions at the harvesting site at month 7
timeFrame: 7 months
measure: primary efficiency of AD-SVF iin term of glands reparation process/repair (Minor salivary gland biopsy)
timeFrame: 6 months
measure: efficacy of AD-SVF at month 1
timeFrame: 1 month
measure: efficacy of AD-SVF at month 3
timeFrame: 3 months
measure: efficacy of AD-SVF at month 6
timeFrame: 6 months
measure: Change in dryness of oral mucosa
timeFrame: 3 months
measure: Change in xerostomia Visual Analogic Scale (VAS)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
References: