Clinical trial NCT05079243: Dermal and Subcutaneous Augmentation and Skin Assessment After Fat-, Stem Cell and Scaffold Injections
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Augmentation
Reconstruction
Lead sponsor: Stemform
Sponsor class: INDUSTRY
Collaborators: name: Rigshospitalet, Denmark
name: Aleris-Hamlet Hospitaler København
First posted: 2021-10-15
Enrollment: 5
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Triple blinded, randomized, paired study on healthy participants
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Volume assessment
timeFrame: Baseline, three months, Six months
Secondary outcomes:
measure: Cell count, immunohistochemistry, skin quality
timeFrame: Three months, six months
measure: Immunohistochemistry
timeFrame: Three months, six months
measure: Skin thickness
timeFrame: Three months, six months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Aleris Hamlet
state: Søborg
city: Copenhagen
country: Denmark
facility: StemMedical
state: Søborg
Study officials:
affiliation: StemMedical A/S
name: Frederik P Mamsen
role: PRINCIPAL_INVESTIGATOR
affiliation: StemMedical A/S
name: stig-Frederik T Koelle, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: