Pilot Study to Evaluate the Safety and the Efficacy of the Matrix and Cells Obtained by the AmeaCell® Device and Intended for the Filling of Wrinkles on the Face. (SKINMAT)

Symbioken

Status

Completed

Conditions

Skin Aging

Treatments

Device: AmeaCell

Study type

Interventional

Funder types

Industry

Identifiers

NCT03529292

SYMB-SAF1701

Details and patient eligibility

About

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.

Full description

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

Enrollment

23 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Man or woman from 18 to 70 years
Subject wishing liposuction
Subject wishing a filling of facial wrinkles for aesthetic purposes
Subject for which it is possible to achieve a puncture of adipose tissue of at least 150ml so that after decantation or centrifugation there remains 100ml of adipose tissue
Facial wrinkles that can be treated with the Matrix and Cells volume of approximately 12ml
Grade of wrinkles at level 2 minimum of the nasolabial fold according to the WSRS scale
Free, informed and written consent
Affiliate or beneficiary of a social security scheme

Exclusion criteria

Pregnant or breastfeeding woman or planning to be pregnant
Woman of childbearing age without effective contraceptive
Subject having a filling of facial wrinkles with hyaluronic acid or by a method of lipofilling (injection of adipose tissue) in the 12 months prior to the enrollment
Subject who has undergone treatment of facial wrinkles by injection of botulinum toxin, by mesotherapy or cosmetic procedure (laser, photo modulation, intense pulsed light, radio frequency, dermabrasion, chemical peel or other ablative procedures) within 12 months at least prior to enrolment or subject who is planning this type of procedure during the study
Subject who has received semi-permanent dermal fillers or permanent facial implants or who is planning to do this type of implant during the study
Subject having history of formation of hypertrophic scars or keloids
Subject having a skin disease or skin inflammation (e.g. acne, herpes, eczema, psoriasis, sclerosis) at the site to be treated or elsewhere on the body if suspected of spreading on the site to be treated
Subject with allergic contact dermatitis or a history of allergic contact dermatitis or a family history of allergic contact dermatitis
Presence of tattoo and / or scar in the treatment area that, in the opinion of the investigator, could interfere with the evaluation of the study
Diabetes (type I or type II)
Human Immunodeficiency Virus (HIV), Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV) seropositivity
Subject under anti-HIV treatment
Autoimmune disease
Immunodepression
History of phlebitis or pulmonary embolism
Major pathology involving the renal, hepatic, cardiovascular, immune and / or nervous system
Cancerous lesion on the face
Any other diseases that could, in the opinion of the investigator, be clinically significant and make the subject inappropriate for the study, alter the results of the study or increase the risk for the subject
Known hypersensitivity to cobalt
Known hypersensitivity to collagenase
Known or suspected allergy to lidocaine or any other amide anesthetic
History of known severe allergies (anaphylaxis, angioedema) for a product used in the study
Any contraindication to lipofilling surgery
Active smoking or subject who stopped smoking less than one month before the intervention
Radiotherapy treatment at the head and neck region.
Chemotherapy treatment
Treatment with anticoagulant or Nonsteroidal anti-inflammatory drug (NSAID) or any other substance known to increase clotting time during the 2 weeks prior to enrollment
Corticosteroids in the 6 weeks prior to enrollment
Subject having a metal-metal hip prosthesis
Subject under lidocaine or structurally related local anesthetic (e.g. bupivacaine) within 24 hours prior to enrollment
Subject having undergone general anesthesia for less than 8 days
Treatment with an oral or topical retinoid in the month prior to enrollment
Subject having a history of drug or alcohol addiction in the 12 months prior to enrollment
Participation in another research including an exclusion period still in progress at the time of enrollment
Person placed under guardianship or curatorship or under the protection of justice