in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds

Официальное название

in Vitro Evaluation of the Anti-fibrotic Activity of Adipose Tissu-derived Stromal Vascular Fraction Used as a Medicinal Treatment for Scarred Vocal Folds: Interest in the Definition of 'Potency' Markers and Optimized Cellular Engineering Trategies

Обзор

This is a single-center, prospective study, aimed at investigating the anti-fibrotic in vitro activity of the stromal vascular fraction of patients with scarred vocal cord.

Подробное описание

This single-center, prospective study will last 28 months and will be carried out in two stages:

1. Comparison of the in vitro anti-fibrotic activity and production/management circuit of different cell therapy products derived from adipose tissue obtained from healthy donors (n=8) \[secondary objective\] during the first 12 months of the project. 2. Evaluate the association between the in vitro anti-fibrotic activity of fraction vascular fraction (FVS) samples and the clinical improvement obtained with the same sample autologously injected into a patient in the CELLCORDES2 trial (minimum recruitment n=10, CELLCORDES2 biocollection) \[primary objective\]. This second stage will be carried out between M12 and M24 to optimize the number of patients to be included.

Вмешательства

• Другое Reuse of surgical waste
  Heathly donnors will be received in the plastic surgery department as part of routine care. They will be informed of the study and their surgical waste (adipose tissue) will be recovered specifically for this research.
• Другое Reuse of biological samples
  Patients included in the cellcordes 2 trial who have given their consent for the re-use of their biological samples (Stromal Vascular Fraction) in other clinical research projects, and who have been informed of the cellcordes bio study.

Первичные конечные точки

• collagene protein levels [Срок оценки: 24 months]
• Actine alpha 2 (ACTA2) RNA levels [Срок оценки: 24 months]
• Alpha Smooth muscle actin (aSMA) protein levels [Срок оценки: 24 months]
• collagen type 1 alpha 1 chain (COL1A1) RNA levels [Срок оценки: 24 months]

Вторичные конечные точки (4)

• collagene protein levels [Срок оценки: 24 months]
• Actine alpha 2 (ACTA2) levels [Срок оценки: 24 months]
• Alpha Smooth muscle actin (aSMA) protein levels [Срок оценки: 24 months]
• ollagen type 1 alpha 1 chain (COL1A1) RNA levels [Срок оценки: 24 months]

Критерии участия

Inclusion criteria for patients included in the CELLCORDES 2 clinical trial

• Voice Handicap Index > 50/120
• Scarring, congenital (sulcus) or post-phonosurgery vocal cords
• Vibratory anomalies in the middle third of one or both vocal cords on stroboscopy
• A minimum of six months after the initial surgery
• Patients aged 18 to 70 years
• Good general health
• Negative pregnancy test and contraception for women of childbearing age Signature of consent for the storage and use of biological samples

Inclusion criteria for Healthy donnors:

• Liposuction surgery for aesthetic reasons
• BMI between 18 and 27
• No chronic diseases
• Non-opposition to the use of surgical waste for research purposes after freezing in a biological collection

Exclusion criteria: For all patients:

• Refusal or inability to comply with the study procedures
• Minors
• Pregnant or breastfeeding women
• Legally protected adults (under guardianship or curatorship)
• Individuals residing in a healthcare or social establishment emergency situations
• Individuals deprived of liberty
• Detainees
• Individuals not covered by a social security scheme
• Use of an experimental drug in the last three months
• Contraindication to local anesthesia
• Anticoagulant treatment
• Coagulation disorders (TP < 65%, TCA > 1.2)
• Premenopausal women of childbearing age without contraception
• Lack of or refusal of informed consent

Exclusion criteria for Patients in the CELLCORDES 2 clinical trial:

• Patients refusing pre- and post-operative speech therapy
• History of malignant lesions or severe dysplasia on the scarred vocal cord
• History of laryngeal papillomatosis
• Active infectious diseases
• Positive serology for HIV1 and 2, p24 Ag, HCV Abs, HBs Ag, HbC Abs, HTLV and II Abs, TPHA
• Need for perioperative antibiotic prophylaxi

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06823908 · RCAPHM24_0513

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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