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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-07

Study Completion Date

2018-06-07

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.

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Detailed Description

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Conditions

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Dysphonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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micro injection of SVF in vocal cords

micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords

Group Type EXPERIMENTAL

micro injection of SVF in vocal cords

Intervention Type OTHER

Interventions

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micro injection of SVF in vocal cords

Intervention Type OTHER

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No