Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

October 25, 2017 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stem cell yield
Time Frame: At baseline right after isolation.
Stem cell yield measured by antibody stained flow cytometry.
At baseline right after isolation.
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.
Cells are cultured from baseline to day 14.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Growth kinetics
Time Frame: Cultured for 7 days and counted.
Growth kinetics measured by culturing. The population doubling time is determined using log phase of growth
Cultured for 7 days and counted.
Adipogenic, chondrogenic and osteogenic differentiation.
Time Frame: 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.
Through study completion, an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

August 31, 2017

Study Completion (Actual)

August 31, 2017

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (Actual)

April 7, 2017

Study Record Updates

Last Update Posted (Actual)

October 26, 2017

Last Update Submitted That Met QC Criteria

October 25, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ASC Aarhus

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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