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

• Sponsor: Assistance Publique Hopitaux De Marseille (Other)
• Overall Status: Completed
• CT.gov ID: NCT02622464
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arm: 1
• Actual Duration (Months): 26
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dysphonia	Other: micro injection of SVF in vocal cords	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 8 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
• Actual Study Start Date: Apr 7, 2016
• Actual Primary Completion Date: Jun 7, 2018
• Actual Study Completion Date: Jun 7, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: micro injection of SVF in vocal cords micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords	Other: micro injection of SVF in vocal cords

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

1. 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 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 [13 months]

   efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assisitance Publique Hopitaux de Marseille	Marseille		France

Sponsors and Collaborators

• Assistance Publique Hopitaux De Marseille

Investigators

• Principal Investigator: Antoine GIOVANNI, MD, assistance publique hôpitaux de marseille
• Study Director: catherine GEINDRE, Assistance Publique Hopitaux De Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Assistance Publique Hopitaux De Marseille
• ClinicalTrials.gov Identifier: NCT02622464
• Other Study ID Numbers: 2015-01
• First Posted: Dec 4, 2015
• Last Update Posted: Mar 7, 2019
• Last Verified: Sep 1, 2018

• Additional relevant MeSH terms: Dysphonia

Study Results

No Results Posted as of Mar 7, 2019