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

Not Applicable

Active, not recruiting

• Conditions: Augmentation; Reconstruction
• Interventions: Biological: Scaffold and adipose-derived stromal cell enriched fat grafts

• Registration Number: NCT05079243
• Lead Sponsor: Stemform

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.

Study Timeline

• Study Start: 2021-06-04
• Study First Submitted: 2021-06-06
• Study First Submitted QC: 2021-10-03
• Study First Posted: 2021-10-15
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-24
• Last Update Posted: 2022-11-28
• Primary Completion: 2022-12-01
• Study Completion: 2023-06-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Scaffold and adipose-derived stromal cell enriched fat grafts	Scaffold and adipose-derived stromal cell enriched fat grafts	Randomized and paired injections. Each participant will receive all 11 solutions.

Primary Outcome Measures

Name	Time	Method
Volume assessment	Baseline, three months, Six months	CT scan

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Aleris Hamlet; 🇩🇰 Copenhagen, Søborg, Denmark

StemMedical; 🇩🇰 Copenhagen, Søborg, Denmark