Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds : A Nonrandomized Controlled Trial

Alexia Mattei (1, 2) , Baptiste Bertrand (3, 4) , Elisabeth Jouve (5, 6) , Théo Blaise (5, 6) , Cecile Philandrianos (3) , Fanny Grimaud (7, 3) , Laurent Giraudo (5) , Houssein Aboudou (3) , Chloe Dumoulin (5) , Laurent Arnaud (3) , Joana Révis (2, 1) , Camille Galant (2, 1) , Mélanie Velier (7, 4) , Julie Veran (5) , Francoise Dignat-George (8, 4) , Patrick Dessi (1, 9) , Florence Sabatier (4) , Jeremy Magalon (4) , Antoine Giovanni (1, 2)

1 Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale [Hôpital de la Conception - APHM]
2 LPL - Laboratoire Parole et Langage
3 LA CONCEPTION - Hôpital de la Conception [CHU - APHM]
4 C2VN - Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research
5 CIC - Centre d'Investigation Clinique [Hôpital de la Conception - APHM]
6 INS - Institut de Neurosciences des Systèmes
7 AMU PHARM - Aix-Marseille Université - Faculté de pharmacie
8 Physiopathologie de l'Endothelium
9 ADES - Anthropologie bio-culturelle, Droit, Ethique et Santé

IMPORTANCE Patients with scarred vocal folds, whether congenitally or after phonosurgery, often exhibit dysphonia that negatively affects daily life and is difficult to treat. The autologous adipose tissue–derived stromal vascular fraction (ADSVF) is a readily accessible source of cells with angiogenic, anti-inflammatory, immunomodulatory, and regenerative properties. OBJECTIVE To evaluate the feasibility and tolerability of local injections of autologous ADSVF in patients with scarred vocal folds. DESIGN, SETTING, AND PARTICIPANTS CELLCORDES (Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction) is a prospective, open-label, single-arm, single-center, nonrandomized controlled trial with a 12-month follow-up and patient enrollment from April 1, 2016, to June 30, 2017. Eight patients with severe dysphonia attributable to vocal fold scarring associated with a congenital malformation or resulting from microsurgical sequelae (voice handicap index score >60 of 120) completed the study. Data analysis was performed from September 1, 2018, to January 1, 2019. INTERVENTIONS Injection of ADSVF into 1 or 2 vocal folds. MAIN OUTCOMES AND MEASURES The primary outcomeswere feasibility and the number and severity of adverse events associated with ADSVF based therapy. The secondary outcomes were changes in vocal assessment, videolaryngostroboscopy, self-evaluation of dysphonia, and quality of life at 1, 6, and 12 months after cell therapy. RESULTS Seven women and 1 man (mean [SD] age, 44.6 [10.4] years) were enrolled in this study. Adverse events associated with liposuction and ADSVF injection occurred; most of them resolved spontaneously. One patient received minor treatment to drain local bruising, another experienced a minor contour defect at the liposuction site. At 12 months, the voice handicap index score was improved in all patients, with a mean (SD) improvement from baseline of 40.1 (21.5) points. Seven patients (88%) were considered to be responders, defined as improvement by 18 points or more in the voice handicap index score (the minimum clinically important difference). CONCLUSIONS AND RELEVANCE The findings suggest that autologous ADSVF injection in scarred vocal folds is feasible and tolerable. The findings require confirmation in a randomized clinical trial with a larger population.

Domaines: Sciences du Vivant [q-bio]; Médecine humaine et pathologie; Linguistique

Alexia Mattei, Baptiste Bertrand, Elisabeth Jouve, Théo Blaise, Cecile Philandrianos, et al.. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds : A Nonrandomized Controlled Trial. Archives of Otorhinolaryngology - Head & Neck Surgery, 2020, ⟨10.1001/jamaoto.2019.4328⟩. ⟨hal-02485357⟩