Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

Study Overview
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Brief Summary
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The aim of the study is to evaluate a physiological concentration of adipose tissue-derived stem cells (ASC) in excised fat versus fat harvested by liposuction. Participants will act as their own control as both extraction methods are performed on each participant.

Detailed Description
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Adipose tissue-derived stem cells are of great interest due to their relevance in regenerative medicine and tissue engineering. A reason, being their capacity for multipotent differentiation, tissue repair and immune modulation. To evaluate a physiological concentration level of ASCs in human fat we investigate two extraction methods of fat, excision and liposuction. This is done through a standardised setup with patients acting their own control. The study is carried out in accordance with the guidelines provided by the International Federation for Adipose Therapeutics and Science and International Society for Cellular Therapy.

Official Title
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Adipose-tissue Derived Stem Cells: Characterization of Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

Conditions
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Mesenchymal Stem Cells

Intervention / Treatment
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* Procedure: Liposuction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible women - over the age of 18 Deemed suitable for abdominoplasty with abdomen pendens, fleur de lis, panniculectomy or belt lipectomy. Able to read and understand Danish Exclusion Criteria: Current smokers - patients not having paused for a minimum of four weeks prior to surgery. Prior or current adjuvant chemo therapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will act as their own control. Each participant will receive both excision and liposuction of fat.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Liposuction of fat<br>The intervention examined is the extraction method by liposuction. | Procedure: Liposuction<br>* Fat harvest by liposuction (Colemans method)<br>|
| No Intervention: Excision of fat<br>Control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stem cell yield | Stem cell yield measured by antibody stained flow cytometry. | At baseline right after isolation. | 
| Stem cell yield | Stem cell yield measured by colony forming units and number of colonies >50 cells are counted. | Cells are cultured from baseline to day 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Growth kinetics | Growth kinetics measured by culturing. The population doubling time is determined using log phase of growth | Cultured for 7 days and counted. | 
| Adipogenic, chondrogenic and osteogenic differentiation. | Differentiation assays for adipogenic, chondrogenic and osteogenic differentiation with Oil Red O staining, Safranin O staining and Alizarin red S staining. | Through study completion, an average of 1 year. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cell, liposuction, regenerative medicine