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

March 4, 2019 updated by: Assistance Publique Hopitaux De Marseille
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France
        • Assisitance Publique Hopitaux de Marseille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: micro injection of SVF in vocal cords
micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords
Other: micro injection of SVF in vocal cords

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
13 months
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
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
Time Frame: 13 months
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
Time Frame: 13 months
efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)
13 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Antoine GIOVANNI, MD, Assistance Publique Hopitaux de Marseille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 7, 2016

Primary Completion (ACTUAL)

June 7, 2018

Study Completion (ACTUAL)

June 7, 2018

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

December 3, 2015

First Posted (ESTIMATE)

December 4, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 7, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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