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

Public Assistance-Hospitals of Marseille (AP-HM)

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Xerostomia

Treatments: Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF); Procedure: lipoaspiration

Study type: Interventional

Funder types: Other

Identifiers

NCT05857358

2023-505149-20-00

Details and patient eligibility

About

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).

Full 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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

Adult patients suffering from xerostomia and autoimmune disease

Experimental group

Description:

Xerostomia treatment consist of 3 steps (including 2 surgical steps) in the Hospital de la Conception of Marseille, in the same ward : * The plastic/maxillofacial surgeon : collects the adipose tissue, and transfers it to the cell therapy unit; * The cell therapy unit processes and controls the experimental product (adipose-derived stromal vascular fraction; AD-SVF) from the harvested adipose tissue. The AD-SVF batch is nominatively transported to the surgeon; * The maxillofacial surgeon injects the AD-SVF without delay under local anesthesia.

Treatment:

Procedure: lipoaspiration

Drug: Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF)