Augmentation, Reconstruction
Conditions
Brief 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.
Interventions
BIOLOGICALScaffold 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
Sponsors
Rigshospitalet, Denmark
Aleris-Hamlet Hospitaler København
Stemform
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Triple blinded, randomized, paired study on healthy participants
Eligibility
Sex/Gender
ALL
Age
25 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
* BMI between 18-30 kg/m2 * 400 mL of fat (lipoaspirate) available for liposuction in the thighs or back * Desire for abdominoplasty * Speaks and reads Danish * Signed informed consent
Exclusion criteria
* Smoking * Previous major abdominal surgery * Previous cancer or predisposition to cancer * Pregnancy or planned pregnancy * Known chronic disease associated with metabolic malfunction or poor healing * Pacemaker * Allergy to necessary anaesthesia * Intention of significant weight loss or weight gain within the trial period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volume assessment | Baseline, three months, Six months | CT scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cell count, immunohistochemistry, skin quality | Three months, six months | Cell count, immunohistochemistry, skin quality |
| Immunohistochemistry | Three months, six months | Immunohistochemistry |
| Skin thickness | Three months, six months | Skin thickness |
Countries
Denmark
Outcome results
None listed