The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face.
The purpose of this study is to evaluate the filling using the Matrix and Cells, obtained by the Ameacell® device from autologous adipose tissue and intended for the filling of wrinkles on the face. This is a mono-center, pilot study in 24 subjects
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Lipoaspirate obtained from liposuction is treated by the AmeaCell® device in order to obtain Matrix and Cells which contains cellular phase and matrix phase. The Matrix ancd Cells are injected in the same patient as facial wrinkles filler.
Hôpital Erasme
Brussels, Belgium
Incidence of the Adverse Event(s)
Adverse events will be investigated and recorded at each visit by the investigator
Time frame: From selection up to 12 months after the injection
Local tolerance
The subject will record daily the local tolerance in a diary card. Signs of erythema, edema, bruising, discolouration, pain / tenderness, and pruritus will be noted and scored from 0 (none) to 3 (severe).
Time frame: First 4 weeks after the injection
Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds
The Wrinkle Severity Rating Scale (WSRS) is a 5-point reference scale with photographs that classifies deep facial wrinkles (Nasolabial Folds). The grading is performed on both sides to give a reliable and reproducible gradation of the depth of the folds. The grading of the wrinkles is made by the investigator according to the following grades: Grade 1 No visible nasolabial folds; continuous skin line Grade 2 Shallow but visible nasolabial folds with a slight indentation Grade 3 Moderate deep nasolabial folds; visible at normal appearance Grade 4 Very long and deep nasolabial folds; prominent facial feature ;\< 2mm visible fold if stretched Grade 5 Extreme deep long nasolabial folds; 2-4mm V shaped fold if stretched
Time frame: Change from baseline at month 1, 6 and 12
Depth of the wrinkles by 3D picture
Time frame: Change from baseline at month 1, 6 and 12
Global Aesthetic Improvement Scale (GAIS) Evaluation
The GAIS scale ("Global Aesthetic Improvement Scale") is a judgment scale noting the apparent overall aesthetic improvement, in comparison with the aspect observed before the injection (on a photograph taken during the day of inclusion). Rating categories are: "Worse"; "No change"; "Slightly improved", "Much improved"; "Very much improved". Evaluations are carried out by the investigator but also by the subject himself according to the same criteria.
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Time frame: Change from baseline at month 1, 6 and 12