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

Study Overview
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Brief Summary
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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.

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

Conditions
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Dysphonia

Intervention / Treatment
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* Other: micro injection of SVF in vocal cords


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: micro injection of SVF in vocal cords<br>micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords | Other: micro injection of SVF in vocal cords<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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 | 13 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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) | 13 months |