Vocal fold scars
Conditions
Interventions
Product Name: FRACTION VASCULAIRE STOMALE AUTOLOGUE
Product Code: FVS
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Autologous stromal vascular fraction from adipose tissue
Curren
Sponsors
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Subscription to the French Social Security System - Signed informed consent - Voice Handicap Index > 50/120 - Scarred vocal folds, congenital (sulcus) or after phonosurgery - Scarred middle third in videolaryngostroboscopy - At least six-months delay after initial surgery if appropriate - Patients aged between 18 and 70 - Good general condition - Negative pregnancy test & contraception for women of child-bearing age Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 8 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Persons having taken an investigational medicinal product in the last three months - Refusal or inability to comply with study procedures - Pregnant and lactating women - Patients under curatorship or guardianship - Persons living in public health facilities or residential care - Minors - Persons without social security coverage - Persons deprived of liberty or detainees - Persons in high risk and emergency situations Specific: - Refusal of speech therapy - History of malignant lesion or severe dysplasia of the scarred vocal fold - History of laryngeal papillomatosis - Contraindication to local anesthesia - Anti-coagulant treatment - Coagulation disorders (Prothrombin Ratio 1,2) - Active infectious diseases - Any active viral infection from among the following: HIV, HTLV I and II, VHB, VHC and Syphilis - Known sensitivity to human serum albumin (HSA) - Known sensitivity to the active substance or to any of the excipients of DEPO-MEDROL® - Necessity of intraoperative prophylactic antibiotics - BMI < 18 kg/m2 to insure adequate abdominal or other subcutaneous adipose tissue accessible to lipoharvest
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to evaluate the safety and tolerability of the study treatment. ;Secondary Objective: The secondary objective is to evaluate the clinical efficiency.;Primary end point(s): efficacity after injection ;Timepoint(s) of evaluation of this end point: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): the safety of the injection of stromal vascular fraction and corticosteroids ;Timepoint(s) of evaluation of this end point: 7 days , one month and six months | — |
Countries
France
Contacts
Public ContactCHEF DE PROJET
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE
Outcome results
None listed