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Trial record 10 of 111 for:    stromal vascular fraction

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

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ClinicalTrials.gov Identifier: NCT02622464
Recruitment Status : Completed
First Posted : December 4, 2015
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Dysphonia Other: micro injection of SVF in vocal cords Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
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 : April 7, 2016
Actual Primary Completion Date : June 7, 2018
Actual Study Completion Date : June 7, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scars

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



Primary Outcome Measures :
  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 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 [ 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02622464


Locations
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France
Assisitance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Antoine GIOVANNI, MD assistance publique hôpitaux de marseille
Study Director: catherine GEINDRE Assistance Publique Hopitaux De Marseille

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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02622464     History of Changes
Other Study ID Numbers: 2015-01
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: September 2018

Additional relevant MeSH terms:
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Dysphonia
Voice Disorders
Laryngeal Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms