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Cosmetic Fat Transplantation Using Expanded ASC Enriched Fat Grafts

Sponsor
Stemform (Industry)
Overall Status
Unknown status
CT.gov ID
NCT03258164
Collaborator
Aleris-Hamlet Hospitaler København (Other)
32
Enrollment
1
Location
2
Arms
50.3
Anticipated Duration (Months)
0.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: ASC enriched lipofilling
  • Biological: Standard Lipofilling
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Fat Transplantation Enriched With Expanded Adipose-derived Autologous Mesenchymal Stromal Cells in Cosmetic Breast Augmentation and Cosmetic Facial Filling
Actual Study Start Date :
Mar 22, 2017
Anticipated Primary Completion Date :
Jan 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: ASC

Biological: ASC enriched lipofilling
Fat grafts enriched with ex vivo expanded ASC
Active Comparator: Control

Biological: Standard Lipofilling
Non-ASC enriched fat grafts

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Criteria breast augmentation:

Inclusion criteria

  1. Age 18 - 50 years

  2. Healthy females

  3. BMI 18 - 30 kg/m2

  4. 1000 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs

  5. Desire for breast augmentation

  6. Speaks and reads Danish or English

  7. Signed informed consent

Exclusion criteria

  1. Smoking

  2. Previous breast surgery

  3. Previous cancer or predisposition to breast cancer

  4. Pregnancy or planned pregnancy within one year after the procedure

  5. Breastfeeding less than 6 months prior to inclusion

  6. Weight gain or loss above 2 BMI point

  7. Known chronic disease associated with metabolism malfunction or pour healing

  8. Pacemaker or other implanted foreign objects

  9. Allergy towards necessary anaesthesia

  10. Intention of weight loss or weight gain within the trial period

Criteria fascial filling

Inclusion criteria

  1. Age 25 - 65 years

  2. Healthy females

  3. BMI 18 - 30 kg/m2

  4. 100 ml of fat (lipoaspirate) available for liposuction at the abdomen and/or thighs

  5. Desire for facial wrinkle treatment and facial augmentation (rejuvenation)

  6. Speaks and reads Danish or English

  7. Signed informed consent

Exclusion criteria

  1. Smoking

  2. Previous facial surgery

  3. Previous cancer

  4. Pregnancy or planned pregnancy within one year after the procedure

  5. Known chronic disease associated with metabolism malfunction or poor healing

  6. Allergy towards necessary anaesthesia

  7. Intention of weight loss or weight gain within the trial period

Contacts and Locations

Locations

Site City State Country Postal Code
1 Stemform Copenhagen Søborg Denmark 2860

Sponsors and Collaborators

  • Stemform
  • Aleris-Hamlet Hospitaler København

Investigators

  • Principal Investigator: Stig-Frederik T Kølle, MD, PhD, Stemform

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Stemform
ClinicalTrials.gov Identifier:
NCT03258164
Other Study ID Numbers:
  • H-16046960
First Posted:
Aug 23, 2017
Last Update Posted:
Jun 24, 2019
Last Verified:
Jun 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Facies

Study Results

No Results Posted as of Jun 24, 2019