Clinical trial
Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
Name
2023-505149-20-00
Description
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).
Trial arms
Trial start
2024-01-01
Estimated PCD
2026-02-01
Trial end
2027-08-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
lipoaspiration
Adipose 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.
Arms:
Adult patients suffering from xerostomia and autoimmune disease
Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)
Autologous 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.
Arms:
Adult patients suffering from xerostomia and autoimmune disease
Size
18
Primary endpoint
Intensity of adverse reactions at the injection site at day 1
1 day
Intensity of adverse reactions at the injection site at day 3
3 days
Intensity of adverse reactions at the injection site at day 7
7 days
Intensity of adverse reactions at the injection site at day 14
14 days
Intensity of adverse reactions at the harvesting site at day 1
1 day
Intensity of adverse reactions at the harvesting site at day 3
3 days
Intensity of adverse reactions at the harvesting site at day 7
7 days
Intensity of adverse reactions at the harvesting site at day 14
14 days
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}
Updated at
2023-11-18
1 organization
1 product
1 indication
Organization
Assistance Publique Hopitaux De MarseilleIndication
Dry Mouth