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NCT Number: NCT01127230

Comparison Between Celution Preparation and Manual Preparation of Adipocyte Derived Regenerative Cells, Using Stromal Vascular Fraction Cell Counts (COMPARE)

This scientific study is meant to establish correlation in Stromal Vascular Fraction (SVF) cell counts between our manual method of harvesting and Cytori's Celution automated system.

Future scientific studies involving Adipocyte Derived Regenerative Cells (ADRCs) will be based on SVF cell counts from the more economical manual method of harvesting if this study shows good correlation.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Life Source Medical Centre

Singapore, 307506

About this study

This study requires lipoaspirate obtained from liposuction. Lipoaspirate is typically discarded in the biohazard waste disposal system. We will be using the lipoaspirate (which would otherwise be discarded) in this study.

Lipoaspirate contains adipose tissues. With a suitable enzymatic separation method, stromal vascular fraction (SVF) can be separated from the adipose cells (adipocyte).

Adipocyte derived regenerative cells has been isolated from the stromal vascular fraction (SVF) of adipose tissues. There are two methods of obtaining the SVF from the adipose tissue in this study. One is called the manual preparation and the other the Celution preparation. The Celution preparation is an automated system, providing a constant standard by which to compare the manual preparation of SVF. This study aims to establish correlation between the manual preparation and Celution preparation.

The purpose of establishing correlation is to allow the manual preparation of SVF to be used in future scientific studies. The manual preparation has the advantage of being more economical than the Celution automated system.

In future scientific studies, we hope to establish correlation between survival rates of fat graft and SVF cell counts. Currently fat grafting is an accepted List A aesthetic procedure in Singapore to enhance facial features and in breast augmentation. However results vary widely among patients, and seems unpredictable. A possible hypothesis is that the survivability of the fat graft is dependent on the number of naturally occurring ADRCs found in the fat graft. In the future we hope to conduct a scientific study on this hypothesis using the manual preparation.

The secondary purpose for this study is to correlate SVF cell counts with the age, sex, weight, BMI and anatomical area of liposuction.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients who already opted for liposuction
  • patients who consents to donate the lipoaspirate after liposuction
  • patients more than 21 years of age

Exclusion criteria

  • patients with history of organ failure
  • patients with history of carcinoma
  • patients who are pregnant

Treatment and study plan

Primary outcomes

  1. Stromal Vascular Fraction Cell Count Ratio

    Time frame: 1 day

    SVF cell count Ratio = SVF cell count from Cytori's Celution : SVF cell count from manual preparation

Secondary outcomes

  1. Stromal Vascular Fraction Cell Count Age Comparison .

    Time frame: 1 day

    SVF cell counts differences in different age groups

Sponsors and collaborators

Lead sponsor

Novena Medical Center

Network

Registry information

Acronym: COMPARE

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 20, 2010
Registry last updated
Jul 19, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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