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Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia
Sponsor: Assistance Publique Hopitaux De Marseille
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).
Official title: Safety and Potential Effect of Innovative Cell-based Therapy Using Adipose-derived Stromal Vascular Fraction in Patients With Autoimmune Xerostomia (XEROCELL)
Key Details
Gender
All
Age Range
18 Years - 65 Years
Study Type
INTERVENTIONAL
Enrollment
18
Start Date
2024-01
Completion Date
2027-08
Last Updated
2023-11-18
Healthy Volunteers
No
Conditions
Interventions
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.
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.