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

Primary Purpose

Dysphonia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
micro injection of SVF in vocal cords
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dysphonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assisitance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

micro injection of SVF in vocal cords

Arm Description

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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
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)

Full Information

First Posted
November 19, 2015
Last Updated
March 4, 2019
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT02622464
Brief Title
Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
Official Title
Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
April 7, 2016 (Actual)
Primary Completion Date
June 7, 2018 (Actual)
Study Completion Date
June 7, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dysphonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
micro injection of SVF in vocal cords
Arm Type
Experimental
Arm Description
micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords
Intervention Type
Other
Intervention Name(s)
micro injection of SVF in vocal cords
Primary Outcome Measure Information:
Title
feasibility of Stromal Vascular Fraction injection injected in vocal cords
Description
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
Title
safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
Description
safety of Stromal Vascular Fraction injection injected in vocal cords
Time Frame
13 months
Secondary Outcome Measure Information:
Title
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
Description
efficiency of SVF injection will be assessed by visual analysis of the vocal cord vibration appreciated by vidéolaryngostroboscopy
Time Frame
13 months
Title
efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
Description
efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)
Time Frame
13 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoine GIOVANNI, MD
Organizational Affiliation
assistance publique hôpitaux de marseille
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
catherine GEINDRE
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assisitance Publique Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
32053141
Citation
Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328.
Results Reference
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Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction

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