Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

Phase 3

Completed

• Conditions: Breast Hypoplasia and Facial Ageing
• Interventions: Biological: ASC enriched lipofilling; Biological: Standard Lipofilling

• Registration Number: NCT03258164
• Lead Sponsor: Stemform

Brief Summary

The purpose of the present study is to examine whether enrichment of a fat graft with autologous ex vivo expanded ASC injected into the breast tissue or face, both for cosmetic use, will significantly improve the results of conventional lipofilling and synthetic facial fillers, thereby being able to offer a safer, more natural and long-lasting alternative to current artificial solutions for cosmetic patients.

Detailed Description

The cosmetic breast augmentation design is a double-blind (surgeon and data assessor) randomized, prospective clinical study on healthy subjects.

The cosmetic facial filling design is a data assessor-blinded, randomized, prospective clinical study on healthy subjects.

Study Timeline

• Study Start: 2017-03-22
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-18
• Study First Posted: 2017-08-23
• Primary Completion: 2022-10-24
• Status Verified: 2022-11
• Study Completion: 2022-11-22
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASC	ASC enriched lipofilling	-
Control	Standard Lipofilling	-

Primary Outcome Measures

Name	Time	Method
Change in volume over time after breast augmentation	Baseline, four and twelve months	Measurement of the residual volume of fat transplants as based on MRI before operation (baseline), and four and twelve months after lipo-injection to the breast in order to determine the difference in volume between baseline and 4 months and 12 months post operative; and thereby the resorption rate over time.

Secondary Outcome Measures

Name	Time	Method
Change in cosmetic facial appearance over time after facial filling	Baseline, one, four and twelve months	Assessment of cosmetic outcome based on clinical photos before (baseline), one, four and twelve months after the procedure when compared to baseline, evaluated by 5 independent plastic surgeons blinded to the intervention using a scale of 1-5 to determine the difference in appearance over time.

Trial Locations

Locations (1)

Stemform; 🇩🇰 Copenhagen, Søborg, Denmark