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

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура 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
• Препарат 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.

Первичные конечные точки

• Intensity of adverse reactions at the injection site at day 1 [Срок оценки: 1 day]
• Intensity of adverse reactions at the injection site at day 3 [Срок оценки: 3 days]
• Intensity of adverse reactions at the injection site at day 7 [Срок оценки: 7 days]
• Intensity of adverse reactions at the injection site at day 14 [Срок оценки: 14 days]
• Intensity of adverse reactions at the harvesting site at day 1 [Срок оценки: 1 day]
• Intensity of adverse reactions at the harvesting site at day 3 [Срок оценки: 3 days]
• Intensity of adverse reactions at the harvesting site at day 7 [Срок оценки: 7 days]
• Intensity of adverse reactions at the harvesting site at day 14 [Срок оценки: 14 days]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05857358 · 2023-505149-20-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗