Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction
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|ClinicalTrials.gov Identifier: NCT03105284|
Recruitment Status : Completed
First Posted : April 7, 2017
Last Update Posted : October 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Mesenchymal Stem Cells||Procedure: Liposuction||Not Applicable|
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 Type :||Interventional|
|Actual Enrollment :||20 participants|
|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|
Active Comparator: Liposuction of fat
The intervention examined is the extraction method by liposuction.
Fat harvest by liposuction (Colemans method)
No Intervention: Excision of fat
- Stem cell yield [ Time Frame: At baseline right after isolation. ]Stem cell yield measured by antibody stained flow cytometry.
- 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.
- 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
- 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.