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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: 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.

Detailed Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

Current Primary Outcome:

• feasibility of Stromal Vascular Fraction injection injected in vocal cords [ Time Frame: 13 months ]
  feasibility will be assessed by observation of the immediate volumizing effect on the edge free of the vocal cord appreciated on the video document
• safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords [ Time Frame: 13 months ]
  safety of Stromal Vascular Fraction injection injected in vocal cords

Original Primary Outcome: Same as current

Current Secondary Outcome:

• efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients [ Time Frame: 13 months ]
  efficiency of SVF injection will be assessed by visual analysis of the vocal cord vibration appreciated by vidéolaryngostroboscopy
• efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients [ Time Frame: 13 months ]
  efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)

Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: November 19, 2015
Date Started: December 2015
Date Completion: May 2017
Last Updated: July 26, 2016
Last Verified: July 2016