Clinical trial NCT03105284: Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction
Official title: Adipose-tissue Derived Stem Cells: Characterization of Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mesenchymal Stem Cells
Keywords: stem cell
liposuction
regenerative medicine
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will act as their own control. Each participant will receive both excision and liposuction of fat.
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Stem cell yield
timeFrame: At baseline right after isolation.
measure: Stem cell yield
timeFrame: Cells are cultured from baseline to day 14.
Secondary outcomes:
measure: Growth kinetics
timeFrame: Cultured for 7 days and counted.
measure: Adipogenic, chondrogenic and osteogenic differentiation.
timeFrame: Through study completion, an average of 1 year.
Other outcomes:
Locations:
Study officials:
References:
citation: Bourin P, Bunnell BA, Casteilla L, Dominici M, Katz AJ, March KL, Redl H, Rubin JP, Yoshimura K, Gimble JM. Stromal cells from the adipose tissue-derived stromal vascular fraction and culture expanded adipose tissue-derived stromal/stem cells: a joint statement of the International Federation for Adipose Therapeutics and Science (IFATS) and the International Society for Cellular Therapy (ISCT). Cytotherapy. 2013 Jun;15(6):641-8. doi: 10.1016/j.jcyt.2013.02.006. Epub 2013 Apr 6.
citation: Alstrup T, Eijken M, Brunbjerg ME, Hammer-Hansen N, Moller BK, Damsgaard TE. Measured Levels of Human Adipose Tissue-Derived Stem Cells in Adipose Tissue Is Strongly Dependent on Harvesting Method and Stem Cell Isolation Technique. Plast Reconstr Surg. 2020 Jan;145(1):142-150. doi: 10.1097/PRS.0000000000006404.