Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

Mesenchymal Stem Cells Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03105284
• Other study ID #: ASC Aarhus
• 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
• 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

Related Conditions & MeSH terms

• Mesenchymal Stem Cells

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.