Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

NCT03105284 | Completed

• 1 other identifier: ASC Aarhus
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Mesenchymal Stem Cells

Keywords

stem cell; liposuction; regenerative medicine

Outcome Measures

Primary Outcomes (2)

• Stem cell yield

  Stem cell yield measured by antibody stained flow cytometry.

  At baseline right after isolation.

• 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 Outcomes (2)

• Growth kinetics

  Cultured for 7 days and counted.

• Adipogenic, chondrogenic and osteogenic differentiation.

  Through study completion, an average of 1 year.

Study Arms (2)

Liposuction of fat

ACTIVE COMPARATOR

The intervention examined is the extraction method by liposuction.

Procedure: Liposuction

Excision of fat

NO INTERVENTION

Control group

Interventions

Liposuction PROCEDURE

Fat harvest by liposuction (Colemans method)

Liposuction of fat

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current smokers - patients not having paused for a minimum of four weeks prior to surgery.
• Prior or current adjuvant chemo therapy

Sponsors & Collaborators

• University of Aarhus: lead

Related Publications (2)

• 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.

  PMID: 23570660 BACKGROUND

• 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.

  PMID: 31881616 DERIVED

MeSH Terms

Interventions

Lipectomy

Intervention Hierarchy (Ancestors)

Cosmetic Techniques; Therapeutics; Bariatric Surgery; Bariatrics; Obesity Management; Surgical Procedures, Operative; Plastic Surgery Procedures

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will act as their own control. Each participant will receive both excision and liposuction of fat.

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: April 7, 2017
• Study Start: September 1, 2016
• Primary Completion: August 31, 2017
• Study Completion: August 31, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-02