Alexia Mattei1,2, Baptiste Bertrand3, Elisabeth Jouve4, Théo Blaise4, Cécile Philandrianos3, Fanny Grimaud5, Laurent Giraudo5, Houssein Aboudou5, Chloé Dumoulin5, Laurent Arnaud5, Joana Revis1,2, Camille Galant1,2, Mélanie Velier5,6, Julie Veran5, Françoise Dignat-George5,6, Patrick Dessi1,7, Florence Sabatier5,6, Jérémy Magalon5,6, Antoine Giovanni1,2. 1. Department of Oto-Rhino-Laryngology and Head and Neck Surgery, Assistance Publique-Hôpitaux de Marseille, La Conception University Hospital, Marseille, France. 2. Laboratoire Parole et Langage, Centre National de la Recherche Scientifique, Aix Marseille University, Aix-en-Provence, France. 3. Department of Plastic and Reconstructive Surgery, Assistance Publique-Hôpitaux de Marseille, La Conception University Hospital, Marseille, France. 4. Assistance 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. 5. Cell 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. 6. Institut 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. 7. French 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.
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.
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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