Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

NCT03258164 | Completed Phase 3 DMC

• 1 other identifier: H-16046960
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Hypoplasia and Facial Ageing

Outcome Measures

Primary Outcomes (1)

• Change in volume over time after breast augmentation

  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.

  Baseline, four and twelve months

Secondary Outcomes (1)

• Change in cosmetic facial appearance over time after facial filling

  Baseline, one, four and twelve months

Study Arms (2)

ASC

EXPERIMENTAL

Biological: ASC enriched lipofilling

Control

ACTIVE COMPARATOR

Biological: Standard Lipofilling

Interventions

ASC enriched lipofilling BIOLOGICAL

Fat grafts enriched with ex vivo expanded ASC

ASC

Standard Lipofilling BIOLOGICAL

Non-ASC enriched fat grafts

Control

Eligibility Criteria

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

You may qualify if:

• Age 18 - 50 years
• Healthy females
• BMI 18 - 30 kg/m2
• 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

You may not qualify if:

• Smoking
• Previous breast surgery
• Previous cancer or predisposition to breast cancer
• Pregnancy or planned pregnancy within one year after the procedure
• 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
• Age 25 - 65 years
• Healthy females
• BMI 18 - 30 kg/m2
• ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs
• Desire for facial wrinkle treatment and facial augmentation (rejuvenation)

Sponsors & Collaborators

• Stemform: lead
• Aleris-Hamlet Hospitaler København: collaborator

Study Sites (1)

Stemform

Copenhagen, Søborg, 2860, Denmark

Location

Study Officials

• Stig-Frederik T Kølle, MD, PhD

  Stemform

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2017
• First Posted: August 23, 2017
• Study Start: March 22, 2017
• Primary Completion: October 24, 2022
• Study Completion: November 22, 2022
• Last Updated: November 28, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)