An interventional study of micro injection of SVF in vocal cords in Dysphonia, sponsored by Assistance Publique Hopitaux De Marseille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-07.
Sponsored by Assistance Publique Hopitaux De Marseille · Not applicable, Interventional, and Treatment
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.
131 studies on the registry are indexed under Dysphonia; 34 are open to participants now.
This study's enrollment of 8 is below the median of 39 across 94 interventional studies indexed under Dysphonia.
Browse Dysphonia studies →Assistance Publique Hopitaux De Marseille is the lead sponsor of 686 studies on the registry; 148 are open to participants now.
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Exclusion Criteria:
micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords
Other: micro injection of SVF in vocal cords
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
Time frame: 13 months
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
Time frame: 13 months
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
Time frame: 13 months
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)
Time frame: 13 months
This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Assistance Publique Hopitaux De Marseille