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

Augmentation Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05079243
• Other study ID #: H-21004160
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 4, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: November 2022
• Source: Stemform
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5
• Est. completion date: June 1, 2023
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Augmentation

Intervention

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

Locations

Country	Name	City	State
Denmark	Aleris Hamlet	Copenhagen	Søborg
Denmark	StemMedical	Copenhagen	Søborg

Sponsors (3)

Lead Sponsor	Collaborator
Stemform	Aleris-Hamlet Hospitaler København, Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume assessment	CT scan	Baseline, three months, Six months
Secondary	Cell count, immunohistochemistry, skin quality	Cell count, immunohistochemistry, skin quality	Three months, six months
Secondary	Immunohistochemistry	Immunohistochemistry	Three months, six months
Secondary	Skin thickness	Skin thickness	Three months, six months