Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

Not Applicable

Completed

• Conditions: Mesenchymal Stem Cells
• Interventions: Procedure: Liposuction

• Registration Number: NCT03105284
• Lead Sponsor: University of Aarhus

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2017-02
• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Primary Completion: 2017-08-31
• Study Completion: 2017-08-31
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

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Exclusion Criteria

• Current smokers - patients not having paused for a minimum of four weeks prior to surgery.
• Prior or current adjuvant chemo therapy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Liposuction of fat	Liposuction	The intervention examined is the extraction method by liposuction.

Primary Outcome Measures

Name	Time	Method
Stem cell yield	Cells are cultured from baseline to day 14.	Stem cell yield measured by colony forming units and number of colonies \>50 cells are counted.

Secondary Outcome Measures

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