Clinical trial NCT02622464: Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
Official title: Innovative Treatment for Scarred Vocal Cords by Local Injection of Autologous Stromal Vascular Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dysphonia
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2015-12-04
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: feasibility of Stromal Vascular Fraction injection injected in vocal cords
timeFrame: 13 months
measure: safety will be assessed by the absence of related events related to stromal vascular fraction injection injected in vocal cords
timeFrame: 13 months
Secondary outcomes:
measure: efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
timeFrame: 13 months
measure: efficiency of SVF injection for the treatment of scarred vocal cords with improved instrumental objective characteristics of the voice of the operated patients
timeFrame: 13 months
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assisitance Publique Hopitaux de Marseille
Study officials:
affiliation: assistance publique hôpitaux de marseille
name: Antoine GIOVANNI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique Hopitaux De Marseille
name: catherine GEINDRE
role: STUDY_DIRECTOR
References:
citation: 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.