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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Augmentation; Reconstruction
• Intervention / Treatment: Biological: Scaffold and adipose-derived stromal cell enriched fat grafts

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Søborg
    • Copenhagen, Søborg, Denmark, 2860
      • Aleris Hamlet
    • Copenhagen, Søborg, Denmark, 2860
      • StemMedical

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Scaffold and adipose-derived stromal cell enriched fat grafts; Randomized and paired injections. Each participant will receive all 11 solutions.	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
No Intervention: Controls samples; Control samples of untreated skin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Volume assessment	CT scan	Baseline, three months, Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cell count, immunohistochemistry, skin quality	Cell count, immunohistochemistry, skin quality	Three months, six months
Immunohistochemistry	Immunohistochemistry	Three months, six months
Skin thickness	Skin thickness	Three months, six months

Collaborators and Investigators

• Sponsor: Stemform
• Collaborators: Rigshospitalet, Denmark; Aleris-Hamlet Hospitaler København
• Investigators: Principal Investigator: Frederik P Mamsen, StemMedical; Principal Investigator: stig-Frederik T Koelle, MD, PhD, StemMedical

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2021
• Primary Completion (Anticipated): December 1, 2022
• Study Completion (Anticipated): June 1, 2023

Study Registration Dates

• First Submitted: June 6, 2021
• First Submitted That Met QC Criteria: October 3, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 28, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: H-21004160

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Upon request IPD can be shared with different parties if assessed valid by the primary investigators

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No