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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-04

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Augmentation Reconstruction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Triple blinded, randomized, paired study on healthy participants

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Scaffold and adipose-derived stromal cell enriched fat grafts

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

Group Type EXPERIMENTAL

Scaffold and adipose-derived stromal cell enriched fat grafts

Intervention Type BIOLOGICAL

eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer

Controls samples

Control samples of untreated skin

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

25 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes