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

July 16, 2010 updated by: Novena Medical Center

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 307506
        • Life Source Medical Centre

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

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Liposuction Patients

Description

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

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?

Cohorts and Interventions

Group / Cohort
Liposuction patients
Patients who already opted and are scheduled for liposuction.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stromal Vascular Fraction Cell Count Age Comparison .
Time Frame: 1 day
SVF cell counts differences in different age groups
1 day

Collaborators and Investigators

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

Sponsor

Novena Medical Center

Investigators

  • Principal Investigator: Kok Leong Tan, MBBS, Life Source Medical Centre

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

March 1, 2010

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

May 19, 2010

First Submitted That Met QC Criteria

May 19, 2010

First Posted (Estimate)

May 20, 2010

Study Record Updates

Last Update Posted (Estimate)

July 19, 2010

Last Update Submitted That Met QC Criteria

July 16, 2010

Last Verified

July 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 01-2010/03/14-S0001

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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