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Clinical Trials/NCT03105284
NCT03105284CompletedNot Applicable

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

University of Aarhus0 sites20 target enrollmentStarted: September 1, 2016Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
20
Primary Endpoint
Stem cell yield

Study Overview

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 Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
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

Arms & Interventions

Excision of fat

No Intervention

Control group

Liposuction of fat

Active Comparator

The intervention examined is the extraction method by liposuction.

Intervention: Liposuction (Procedure)

Outcomes

Primary Outcomes

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.

Stem cell yield

Time Frame: At baseline right after isolation.

Stem cell yield measured by antibody stained flow cytometry.

Secondary Outcomes

  • Adipogenic, chondrogenic and osteogenic differentiation.(Through study completion, an average of 1 year.)
  • Growth kinetics(Cultured for 7 days and counted.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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