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

Not Applicable

Completed

• Conditions: Dysphonia
• Interventions: Other: micro injection of SVF in vocal cords

• Registration Number: NCT02622464
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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 Description

Not available

Study Timeline

• Study First Submitted: 2015-11-19
• Study First Submitted QC: 2015-12-03
• Study First Posted: 2015-12-04
• Study Start: 2016-04-07
• Primary Completion: 2018-06-07
• Study Completion: 2018-06-07
• Status Verified: 2018-09
• Last Update Submitted: 2019-03-04
• Last Update Posted: 2019-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
micro injection of SVF in vocal cords	micro injection of SVF in vocal cords	micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords

Primary Outcome Measures

Name	Time	Method
feasibility of Stromal Vascular Fraction injection injected in vocal cords	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	13 months	safety of Stromal Vascular Fraction injection injected in vocal cords

Secondary Outcome Measures

Name	Time	Method
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 will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)

Trial Locations

Locations (1)

Assisitance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France