Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

• Sponsor: University of Aarhus (Other)
• Overall Status: Completed
• CT.gov ID: NCT03105284
• Collaborator: (none)
• Enrollment: 20
• Arms: 2
• Actual Duration (Months): 12

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mesenchymal Stem Cells	Procedure: Liposuction	N/A

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
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Participants will act as their own control. Each participant will receive both excision and liposuction of fat.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: Sep 1, 2016
• Actual Primary Completion Date: Aug 31, 2017
• Actual Study Completion Date: Aug 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Liposuction of fat The intervention examined is the extraction method by liposuction.	Procedure: Liposuction; Fat harvest by liposuction (Colemans method)
No Intervention: Excision of fat Control group

Outcome Measures

Primary Outcome Measures

1. Stem cell yield [At baseline right after isolation.]

   Stem cell yield measured by antibody stained flow cytometry.

2. Stem cell yield [Cells are cultured from baseline to day 14.]

   Stem cell yield measured by colony forming units and number of colonies >50 cells are counted.

Secondary Outcome Measures

1. Growth kinetics [Cultured for 7 days and counted.]

   Growth kinetics measured by culturing. The population doubling time is determined using log phase of growth

2. Adipogenic, chondrogenic and osteogenic differentiation. [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Aarhus

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: University of Aarhus
• ClinicalTrials.gov Identifier: NCT03105284
• Other Study ID Numbers: ASC Aarhus
• First Posted: Apr 7, 2017
• Last Update Posted: Oct 26, 2017
• Last Verified: Feb 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Aarhus: stem cell; liposuction; regenerative medicine

Study Results

No Results Posted as of Oct 26, 2017