Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds : A Nonrandomized Controlled Trial
| Autor: | Patrick Dessi, Joana Revis, Cécile Philandrianos, Florence Sabatier, Françoise Dignat-George, Julie Veran, Alexia Mattei, Camille Galant, Jeremy Magalon, Elisabeth Jouve, Melanie Velier, Baptiste Bertrand, Laurent Giraudo, A. Giovanni, Fanny Grimaud, Houssein Aboudou, Laurent Arnaud, Chloé Dumoulin, Théo Blaise |
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| Přispěvatelé: | Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale [Hôpital de la Conception - APHM], Assistance Publique - Hôpitaux de Marseille (APHM), Laboratoire Parole et Langage (LPL), Aix Marseille Université (AMU)-Centre National de la Recherche Scientifique (CNRS), Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Centre recherche en CardioVasculaire et Nutrition = Center for CardioVascular and Nutrition research (C2VN), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE), Centre d'Investigation Clinique [Hôpital de la Conception - APHM] (CIC), Aix Marseille Université (AMU)-Assistance Publique - Hôpitaux de Marseille (APHM)-Institut Paoli-Calmettes, Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Fédération nationale des Centres de lutte contre le Cancer (FNCLCC)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital de la Conception [CHU - APHM] (LA CONCEPTION), Institut de Neurosciences des Systèmes (INS), Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM), Aix-Marseille Université - Faculté de pharmacie (AMU PHARM), Aix Marseille Université (AMU), Physiopathologie de l'Endothelium, Vascular research center of Marseille (VRCM), Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU), Anthropologie bio-culturelle, Droit, Ethique et Santé (ADES), Aix Marseille Université (AMU)-EFS ALPES MEDITERRANEE-Centre National de la Recherche Scientifique (CNRS), The project was promoted by the Assistance Publique des Hôpitaux de Marseille, with a funding from grant ET-3714 from the Fondation de l’Avenir pour la Recherche Médicale Appliquée and grant 48-2014 from the Fondation des Gueules Cassées., Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Aix Marseille Université (AMU)-Institut National de la Santé et de la Recherche Médicale (INSERM) |
| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Adult
Male 0301 basic medicine medicine.medical_specialty medicine.medical_treatment [SDV]Life Sciences [q-bio] Population Vocal Cords Mesenchymal Stem Cell Transplantation Transplantation Autologous Speech Acoustics Injections law.invention Cicatrix 03 medical and health sciences 0302 clinical medicine Phonation Randomized controlled trial law medicine Humans Voice Handicap Index [SHS.LANGUE]Humanities and Social Sciences/Linguistics education Original Investigation education.field_of_study business.industry Middle Aged Dysphonia 3. Good health Surgery Transplantation Treatment Outcome 030104 developmental biology medicine.anatomical_structure Adipose Tissue Otorhinolaryngology Tolerability 030220 oncology & carcinogenesis Vocal folds Liposuction Quality of Life Feasibility Studies Female business [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology |
| Zdroj: | Archives of Otorhinolaryngology-Head & Neck Surgery Archives of Otorhinolaryngology-Head & Neck Surgery, JAMA Network-American Medical Association, 2020, ⟨10.1001/jamaoto.2019.4328⟩ JAMA Otolaryngol Head Neck Surg Archives of Otorhinolaryngology-Head & Neck Surgery, 2020, ⟨10.1001/jamaoto.2019.4328⟩ |
| ISSN: | 2168-6181 2168-619X |
| DOI: | 10.1001/jamaoto.2019.4328⟩ |
| Popis: | 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 |
| Databáze: | OpenAIRE |
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