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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| micro injection of SVF in vocal cords | Experimental | micro injection of Stromal Vascular Fraction extracted from autologous adipose tissue in vocal cords |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| micro injection of SVF in vocal cords | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antoine GIOVANNI, MD | assistance publique hôpitaux de marseille | Principal Investigator |
| catherine GEINDRE | Assistance Publique Hopitaux De Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assisitance Publique Hopitaux de Marseille | Marseille | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32053141 | Derived | Mattei A, Bertrand B, Jouve E, Blaise T, Philandrianos C, Grimaud F, Giraudo L, Aboudou H, Dumoulin C, Arnaud L, Revis J, Galant C, Velier M, Veran J, Dignat-George F, Dessi P, Sabatier F, Magalon J, Giovanni A. Feasibility of First Injection of Autologous Adipose Tissue-Derived Stromal Vascular Fraction in Human Scarred Vocal Folds: A Nonrandomized Controlled Trial. JAMA Otolaryngol Head Neck Surg. 2020 Apr 1;146(4):355-363. doi: 10.1001/jamaoto.2019.4328. |
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| ID | Term |
|---|---|
| D055154 | Dysphonia |
| ID | Term |
|---|---|
| D014832 | Voice Disorders |
| D007818 | Laryngeal Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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efficiency will be assessed by the questionnaire Voice Handicap Index 30 (Jacobson) |
| 13 months |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |