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.

NCT03529292 | Completed

• 1 other identifier: SYMB-SAF1701
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin Aging

Outcome Measures

Primary Outcomes (2)

• Incidence of the Adverse Event(s)

  Adverse events will be investigated and recorded at each visit by the investigator

  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).

  First 4 weeks after the injection

Secondary Outcomes (3)

• Wrinkle Severity Rating Scale (WSRS) Evaluation for the nasolabial folds

  Change from baseline at month 1, 6 and 12

• Depth of the wrinkles by 3D picture

  Change from baseline at month 1, 6 and 12

• Global Aesthetic Improvement Scale (GAIS) Evaluation

  Change from baseline at month 1, 6 and 12

Study Arms (1)

Matrix and Cells obtained by the AmeaCell® device

EXPERIMENTAL

Device: AmeaCell

Interventions

AmeaCell DEVICE

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.

Matrix and Cells obtained by the AmeaCell® device

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Symbioken: lead

Study Sites (1)

Hôpital Erasme

Brussels, Belgium

Location

Study Officials

• Dr Cuylits

  Hôpital Erasme, Bruxelles, BELGIUM

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2018
• First Posted: May 18, 2018
• Study Start: July 9, 2018
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

BE (1)