NCT02622464

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 4, 2015

Completed
4 months until next milestone

Study Start

First participant enrolled

April 7, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 7, 2018

Completed
Last Updated

March 7, 2019

Status Verified

September 1, 2018

Enrollment Period

2.2 years

First QC Date

November 19, 2015

Last Update Submit

March 4, 2019

Conditions

Dysphonia

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients

    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

    13 months

Study Arms (1)

micro injection of SVF in vocal cords

EXPERIMENTAL

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

Other: micro injection of SVF in vocal cords

Interventions

micro injection of SVF in vocal cordsOTHER
micro injection of SVF in vocal cords

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assisitance Publique Hopitaux de Marseille

Marseille, France

Location

Related Publications (1)

  • 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.

    PMID: 32053141DERIVED

MeSH Terms

Conditions

Dysphonia

Condition Hierarchy (Ancestors)

Voice DisordersLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Antoine GIOVANNI, MD

    assistance publique hôpitaux de marseille

    PRINCIPAL INVESTIGATOR

  • catherine GEINDRE

    Assistance Publique Hopitaux De Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 19, 2015

First Posted

December 4, 2015

Study Start

April 7, 2016

Primary Completion

June 7, 2018

Study Completion

June 7, 2018

Last Updated

March 7, 2019

Record last verified: 2018-09

Locations

FR(1)