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Completed

NCT Number: NCT03105284

Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

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.

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Key information

Conditions

Mesenchymal Stem Cells

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposuction

Procedure

Fat harvest by liposuction (Colemans method)

Primary outcomes

  1. Stem cell yield

    Time frame: At baseline right after isolation.

    Stem cell yield measured by antibody stained flow cytometry.

  2. Stem cell yield

    Time frame: 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 outcomes

  1. Growth kinetics

    Time frame: Cultured for 7 days and counted.

    Growth kinetics measured by culturing. The population doubling time is determined using log phase of growth

  2. Adipogenic, chondrogenic and osteogenic differentiation.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 7, 2017
Registry last updated
Oct 26, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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