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Completed

NCT Number: NCT02622464

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

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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Key information

Conditions

Dysphonia Laryngeal Diseases Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms Voice Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Assisitance Publique Hopitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

micro injection of SVF in vocal cords

Other

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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)

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Dec 4, 2015
Registry last updated
Mar 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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