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Not yet recruiting NCT05857358

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

Phase I / Phase II Interventional Xerostomia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: lipoaspiration, Injection of the autologous adipose-derived stromal vascular fraction (AD-SVF).
Who it may be relevant to
Registry conditions: Xerostomia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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 canu
  • 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.

Primary outcome measures

  • Intensity of adverse reactions at the injection site at day 1 [Time frame: 1 day]
  • Intensity of adverse reactions at the injection site at day 3 [Time frame: 3 days]
  • Intensity of adverse reactions at the injection site at day 7 [Time frame: 7 days]
  • Intensity of adverse reactions at the injection site at day 14 [Time frame: 14 days]
  • Intensity of adverse reactions at the harvesting site at day 1 [Time frame: 1 day]
  • Intensity of adverse reactions at the harvesting site at day 3 [Time frame: 3 days]
  • Intensity of adverse reactions at the harvesting site at day 7 [Time frame: 7 days]
  • Intensity of adverse reactions at the harvesting site at day 14 [Time frame: 14 days]
Secondary outcome measures (12)
  • Intensity of adverse reactions at the injection site at day 15 [Time frame: 15 days]
  • Intensity of adverse reactions at the injection site at month 1 [Time frame: 1 month]
  • Intensity of adverse reactions at the injection site at month 3 [Time frame: 3 months]
  • Intensity of adverse reactions at the injection site at month 6 [Time frame: 6 months]
  • Intensity of adverse reactions at the injection site at month 7 [Time frame: 7 months]
  • Intensity of adverse reactions at the harvesting site at day 15 [Time frame: 15 days]
  • Intensity of adverse reactions at the harvesting site at month 1 [Time frame: 1 month]
  • Intensity of adverse reactions at the harvesting site at month 3 [Time frame: 3 months]
  • Intensity of adverse reactions at the harvesting site at month 6 [Time frame: 6 months]
  • Intensity of adverse reactions at the harvesting site at month 7 [Time frame: 7 months]
  • primary efficiency of AD-SVF iin term of glands reparation process/repair (Minor salivary gland biopsy) [Time frame: 6 months]
  • efficacy of AD-SVF at month 1 [Time frame: 1 month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05857358 · 2023-505149-20-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗