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| Name | Class |
|---|---|
| Aleris-Hamlet Hospitaler København | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASC | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ASC enriched lipofilling | Biological | Fat grafts enriched with ex vivo expanded ASC |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in cosmetic facial appearance over time after facial filling | 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. | Baseline, one, four and twelve months |
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Criteria breast augmentation:
Inclusion criteria
Exclusion criteria
Criteria fascial filling
Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stig-Frederik T Kølle, MD, PhD | Stemform | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stemform | Copenhagen | Søborg | 2860 | Denmark |
Results will be published in international medical journals
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| Standard Lipofilling |
| Biological |
Non-ASC enriched fat grafts |
|