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

Stemform

Status: Active, not recruiting

Conditions: Reconstruction; Augmentation

Treatments: Biological: Scaffold and adipose-derived stromal cell enriched fat grafts

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05079243

H-21004160

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5 patients

Sex: All

Ages: 25 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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5 participants in 2 patient groups

Scaffold and adipose-derived stromal cell enriched fat grafts

Experimental group

Description:

Randomized and paired injections. Each participant will receive all 11 solutions.

Treatment:

Biological: Scaffold and adipose-derived stromal cell enriched fat grafts

Controls samples

No Intervention group

Description:

Control samples of untreated skin