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Master Thesis

La fraction vasculaire stromale autologue d'origine adipeuse dans le traitement des lésions cicatricielles des cordes vocales

Abstract : Background: Patients with scarred vocal folds, whether congenitally or following phonosurgery, often exhibit a dysphonia that negatively impacts daily life and is difficult to treat. Autologous adipose tissue-derived stromal vascular fraction (ADSVF) is increasingly recognized as an easily accessible source of cells with angiogenic, anti-inflammatory, immunomodulatory, and regenerative properties. We aimed to evaluate the feasibility, safety, tolerability and potential efficacy of autologous ADSVF local injections in patients with scarred vocal folds. Methods: This first-in-man phase I clinical trial was a prospective, open-label, single arm, single-center study with 12-month follow-up that enrolled 8 patients (7 female, 1 male), with severe dysphonia due to vocal folds scarring (Voice Handicap Index [VHI] > 60/120). ADSVF was prepared and injected into one or two vocal folds. The primary outcome was the feasibility and the number and severity of adverse events related to ADSVF-based therapy. Secondary endpoints were changes in vocal assessment, videolaryngostroboscopy and self-evaluation of dysphonia and quality of life from baseline to 1, 6 and 12 months after cell therapy. Findings: Safety and feasibility were evident with the only adverse events related to liposuction and ADSVF injection anticipated and resolved spontaneously. One patient received massage by a physiotherapist to drain local brusing and another complained of a minor contour defect at the liposuction site. At 12 months, VHI was improved in all patients with a mean improvement from baseline of 40.1 ± 21.5 (p = 0.012). Seven patients were considered as responders defined as an improvement ≥ 18 points corresponding to the minimum clinical important difference for the VHI. A trend towards improvement of roughness of voice in perceptual analysis was also observed. The main limitations were those of a pilot study design (limited number of patients, different etiologies of scarred vocal folds involved, unblinded trial without control group). Conclusion: This study outlines the safety of the autologous ADSVF injection in scarred vocal folds and suggests potential efficacy that encourages further confirmation in a future randomised placebo-controlled trial on a larger population.
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Submitted on : Monday, July 1, 2019 - 4:55:20 PM
Last modification on : Friday, October 23, 2020 - 4:58:57 PM


Thèse Alexia Mattei 05-04-201...
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  • HAL Id : dumas-02170156, version 1



Alexia Mattei. La fraction vasculaire stromale autologue d'origine adipeuse dans le traitement des lésions cicatricielles des cordes vocales. Sciences du Vivant [q-bio]. 2019. ⟨dumas-02170156⟩



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