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Adipose-tissue Derived Stem Cells in Flaps Versus Liposuction

NCT ID: NCT03105284

Last Updated: 2017-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-01

Study Completion Date

2017-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Mesenchymal Stem Cells

Keywords

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stem cell liposuction regenerative medicine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Participants will act as their own control. Each participant will receive both excision and liposuction of fat.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Liposuction of fat

The intervention examined is the extraction method by liposuction.

Group Type ACTIVE_COMPARATOR

Liposuction

Intervention Type PROCEDURE

Fat harvest by liposuction (Colemans method)

Excision of fat

Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Liposuction

Fat harvest by liposuction (Colemans method)

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

References

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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.

Reference Type BACKGROUND
PMID: 23570660 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31881616 (View on PubMed)

Other Identifiers

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ASC Aarhus

Identifier Type: -

Identifier Source: org_study_id