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Original Investigation
February 13, 2020

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

Author Affiliations
  • 1Department of Oto-Rhino-Laryngology and Head and Neck Surgery, Assistance Publique–Hôpitaux de Marseille, La Conception University Hospital, Marseille, France
  • 2Laboratoire Parole et Langage, Centre National de la Recherche Scientifique, Aix Marseille University, Aix-en-Provence, France
  • 3Department of Plastic and Reconstructive Surgery, Assistance Publique–Hôpitaux de Marseille, La Conception University Hospital, Marseille, France
  • 4Assistance Publique–Hôpitaux de Marseille, Institut National de la Sante et de la Recherche Medicale, Institut de Neurosciences des Systèmes, Service de Pharmacologie Clinique et Pharmacovigilance, Centre d’Investigation Clinique Centre de Pharmacologie Clinique et d’Évaluation Thérapeutique, Aix Marseille University, Marseille, France
  • 5Cell Therapy Department, Assistance Publique–Hôpitaux de Marseille, Institut National de la Sante et de la Recherche Medicale, La Conception University Hospital, Aix Marseille University, Marseille, France
  • 6Institut National de la Sante et de la Recherche Medicale and Institut National de la Recherche Agronomique, Aix Marseille University, Centre Recherche en CardioVasculaire et Nutrition, Marseille, France
  • 7French National Centre for Scientific Research, Centre National de la Recherche Scientifique, Etablissement Français du Sang, Anthropologie bio-culturelle, Droit, Ethique et Santé, Aix Marseille University, Marseille, France
JAMA Otolaryngol Head Neck Surg. 2020;146(4):355-363. doi:10.1001/jamaoto.2019.4328
Key Points

Question  Is autologous adipose tissue–derived stromal vascular fraction feasible as a new treatment for scarred vocal folds?

Findings  In this nonrandomized controlled trial of 8 patients (7 women and 1 man) with severe dysphonia due to vocal fold scarring, only anticipated adverse events associated with liposuction and adipose tissue–derived stromal vascular fraction injection occurred but resolved spontaneously.

Meaning  The findings suggest that injection of autologous adipose tissue–derived stromal vascular fraction in scarred vocal folds is feasible and deserves further evaluation in a randomized clinical trial.

Abstract

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 outcomes were 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, and 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.

Trial Registration  ClinicalTrials.gov Identifier: NCT02622464

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