Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction

Assistance Publique Hopitaux De Marseille8 enrolled

Overview

Post-operative scarring on vocal cords is responsible for disorders of the vibration of the lining to the original dysphonia can be troublesome for the patient both in his private and professional life. There is no currently codified treatment for this type of situation and no therapeutic antifibrotic has been effective. Cell therapy is a promising new approach.After a liposuction and removing of mature adipocytes (40 to 60%), the remaining cells called stromal vascular fraction (SVF) could be isolated. SVF consists of a heterogeneous cell population including multipotent stem cells similar to mesenchymal stem cells present in bone marrow. The investigators hypothesis is that the trophic and antifibrotic properties of SVF could benefit patients with vocal cords scarring responsible for dysphonia.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Dysphonia

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Vocal Difficulties felt as crippling (VHI \> 60/120) * Presence of scar hurts of the caused vocal cords is by the initial surgery (micro-laryngoscopy in suspension with or without laser) or by a congenital pathology of glottidis sulcus * Scar Aspect of vocal cords judged on a stroboscopic examination * Delay of at least 1 year with regard to the initial surgery Exclusion Criteria: * Patients refusing the speech therapy * Patients operated for a malignant lesion or in malignant potential serious dysplasia of the scar vocal cord * Contraindication in the anesthesia * Patients under anti-coagulants * Patients presenting disorders of the coagulation * Active infectious diseases

Outcomes

Primary Outcomes

feasibility of Stromal Vascular Fraction injection injected in vocal cords

feasibility will be assessed by observation of the immediate volumizing effect on the edge free of the vocal cord appreciated on the video document

Time frame: 13 months

safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords

safety of Stromal Vascular Fraction injection injected in vocal cords

Time frame: 13 months

Secondary Outcomes

efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients

efficiency of SVF injection will be assessed by visual analysis of the vocal cord vibration appreciated by vidéolaryngostroboscopy

Time frame: 13 months

efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients

efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)

Time frame: 13 months

Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes