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Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03105284
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : October 26, 2017
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Mesenchymal Stem Cells Procedure: Liposuction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will act as their own control. Each participant will receive both excision and liposuction of fat.
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Adipose-tissue Derived Stem Cells: Characterization of Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction
Actual Study Start Date : September 1, 2016
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : August 31, 2017

Arm Intervention/treatment
Active Comparator: Liposuction of fat
The intervention examined is the extraction method by liposuction.
Procedure: Liposuction
Fat harvest by liposuction (Colemans method)

No Intervention: Excision of fat
Control group

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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Responsible Party: University of Aarhus Identifier: NCT03105284     History of Changes
Other Study ID Numbers: ASC Aarhus
First Posted: April 7, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: February 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Aarhus:
stem cell
regenerative medicine