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

Dysphonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02622464
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• Start date: April 7, 2016
• Est. completion date: June 7, 2018

Study information

• Verified date: September 2018
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 7, 2018
• Est. primary completion date: June 7, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dysphonia

Intervention

Other:
• micro injection of SVF in vocal cords

Locations

Country	Name	City	State
France	Assisitance Publique Hopitaux de Marseille	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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	13 months
Secondary	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)	13 months