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OpenTrials
Completed

NCT Number: NCT03258164

Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

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.

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Key information

Conditions

Breast Hypoplasia and Facial Ageing

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Stemform

Copenhagen, Søborg, 2860, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Criteria breast augmentation:

Inclusion criteria

  • Age 18 - 50 years
  • Healthy females
  • BMI 18 - 30 kg/m2
  • 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
  • Desire for breast augmentation
  • Speaks and reads Danish or English
  • Signed informed consent

Exclusion criteria

  • Smoking
  • Previous breast surgery
  • Previous cancer or predisposition to breast cancer
  • Pregnancy or planned pregnancy within one year after the procedure
  • Breastfeeding less than 6 months prior to inclusion
  • Weight gain or loss above 2 BMI point
  • Known chronic disease associated with metabolism malfunction or pour healing
  • Pacemaker or other implanted foreign objects
  • Allergy towards necessary anaesthesia
  • Intention of weight loss or weight gain within the trial period

Criteria fascial filling

Inclusion criteria

  • Age 25 - 65 years
  • Healthy females
  • BMI 18 - 30 kg/m2
  • 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
  • Desire for facial wrinkle treatment and facial augmentation (rejuvenation)
  • Speaks and reads Danish or English
  • Signed informed consent

Exclusion criteria

  • Smoking
  • Previous facial surgery
  • Previous cancer
  • Pregnancy or planned pregnancy within one year after the procedure
  • Known chronic disease associated with metabolism malfunction or poor healing
  • Allergy towards necessary anaesthesia
  • Intention of weight loss or weight gain within the trial period

Treatment and study plan

ASC enriched lipofilling

Biological

Fat grafts enriched with ex vivo expanded ASC

Standard Lipofilling

Biological

Non-ASC enriched fat grafts

Primary outcomes

  1. Change in volume over time after breast augmentation

    Time frame: 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 outcomes

  1. Change in cosmetic facial appearance over time after facial filling

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Stemform

Industry

Collaborators

  • Aleris-Hamlet Hospitaler København

Registry information

Official study title

Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling

Important dates

Study start
2017
Primary completion
2022
Study completion
2022
First posted
Aug 23, 2017
Registry last updated
Nov 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.