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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03105284
Other study ID # ASC Aarhus
Secondary ID
Status Completed
Phase N/A
First received February 27, 2017
Last updated October 25, 2017
Start date September 1, 2016
Est. completion date August 31, 2017

Study information

Verified date February 2017
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date August 31, 2017
Est. primary completion date August 31, 2017
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Liposuction
Fat harvest by liposuction (Colemans method)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Stem cell yield Stem cell yield measured by antibody stained flow cytometry. At baseline right after isolation.
Primary Stem cell yield Stem cell yield measured by colony forming units and number of colonies >50 cells are counted. Cells are cultured from baseline to day 14.
Secondary Growth kinetics Growth kinetics measured by culturing. The population doubling time is determined using log phase of growth Cultured for 7 days and counted.
Secondary Adipogenic, chondrogenic and osteogenic differentiation. Differentiation assays for adipogenic, chondrogenic and osteogenic differentiation with Oil Red O staining, Safranin O staining and Alizarin red S staining. Through study completion, an average of 1 year.
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