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Trial record 10 of 109 for:    stromal vascular fraction

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

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ClinicalTrials.gov Identifier: NCT01127230
Recruitment Status : Completed
First Posted : May 20, 2010
Last Update Posted : July 19, 2010
Sponsor:
Information provided by:
Novena Medical Center

Brief Summary:

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.


Condition or disease
Obesity

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.


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Study Type : Observational
Estimated Enrollment : 100 participants
Official Title: Comparison Between Celution Preparation and Manual Preparation of Adipocyte Derived Regenerative Cells, Using Stromal Vascular Fraction Cell Counts (COMPARE)
Study Start Date : March 2010
Actual Primary Completion Date : July 2010
Actual Study Completion Date : July 2010

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



Primary Outcome Measures :
  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 Outcome Measures :
  1. Stromal Vascular Fraction Cell Count Age Comparison . [ Time Frame: 1 day ]
    SVF cell counts differences in different age groups


Biospecimen Retention:   Samples With DNA
Lipoaspirate from liposuction.


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Liposuction Patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127230


Locations
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Singapore
Life Source Medical Centre
Singapore, Singapore, 307506
Sponsors and Collaborators
Novena Medical Center
Investigators
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Principal Investigator: Kok Leong Tan, MBBS Life Source Medical Centre

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Responsible Party: Dr Tan Kok Leong, Life Source Medical Centre
ClinicalTrials.gov Identifier: NCT01127230     History of Changes
Other Study ID Numbers: 01-2010/03/14-S0001
First Posted: May 20, 2010    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

Keywords provided by Novena Medical Center:
ADRC
adipocyte derived regenerative cells
stem cells
liposuction
Cytori
Celution
Lipoaspirate is obtained from patients who have opted for liposuction and consent to donate the lipoasirate for this study, which would otherwise be discarded.