NCT05079243

Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections

Examining the Best Solution for Dermal and Subcutaneous Augmentation and Regeneration Using Ex-vivo Expanded Autologous Adipose-derived Stromal Cells, Autologous Fat Tissue and Natural Tissue Scaffolds

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Stemform · Industry
• Sex: All
• Age: 25 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Augmentation
• Reconstruction

Interventions

Type	Name	Description
BIOLOGICAL	Scaffold and adipose-derived stromal cell enriched fat grafts	eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer

Timeline

• Start date: 2021-06-04
• Primary completion: 2022-12-01
• Completion: 2023-06-01
• First posted: 2021-10-15
• Last updated: 2022-11-28

Locations

2 sites across 1 country: Denmark