NCT05857358

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Xerostomia

Interventions

Type	Name	Description
PROCEDURE	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.
DRUG	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.

Timeline

• Start date: 2024-01-01
• Primary completion: 2026-02-01
• Completion: 2027-08-01
• First posted: 2023-05-12
• Last updated: 2023-11-18