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| Name | Class |
|---|---|
| Rigshospitalet, Denmark | OTHER |
| Aleris-Hamlet Hospitaler København | OTHER |
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Investigate the effect of dermal/subcutaneous injection of ASC enriched fat transplant in a protective natural scaffold, designed to sustain the ASC viability after dermal/subcutaneous injection.
The study investigates the effect of different concentrations of autologous ex-vivo expanded adipose-derived stromal cells (ASCs), fat and a natural scaffold for skin rejuvenation and augmentation. The aim is to better the volume of fat grafts for cosmetic and reconstructive purposes. Fat is a near ideal filler, as it is biocompatible. However the retention rate of fat grafts often result in poor outcomes and it is unpredictable. The investigators have set up an experimental study in which participants with excess abdominal skin is recruited. They will have injections with 11 different solutions of fat, ACSs, scaffold and dermal CO2 laser in the abdominal skin. After 3 months biopsies will be taken and after 6 months all of the treated area will be removed by an cosmetic abdominoplasty.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Scaffold and adipose-derived stromal cell enriched fat grafts | Experimental | Randomized and paired injections. Each participant will receive all 11 solutions. |
|
| Controls samples | No Intervention | Control samples of untreated skin |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaffold and adipose-derived stromal cell enriched fat grafts | Biological | eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer |
| Measure | Description | Time Frame |
|---|---|---|
| Volume assessment | CT scan | Baseline, three months, Six months |
| Measure | Description | Time Frame |
|---|---|---|
| Cell count, immunohistochemistry, skin quality | Cell count, immunohistochemistry, skin quality | Three months, six months |
| Immunohistochemistry | Immunohistochemistry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederik P Mamsen | StemMedical A/S | Principal Investigator |
| stig-Frederik T Koelle, MD, PhD | StemMedical A/S | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aleris Hamlet | Copenhagen | Søborg | 2860 | Denmark | ||
| StemMedical |
Upon request IPD can be shared with different parties if assessed valid by the primary investigators
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Triple blinded, randomized, paired study on healthy participants
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| Three months, six months |
| Skin thickness | Skin thickness | Three months, six months |
| Copenhagen |
| Søborg |
| 2860 |
| Denmark |