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

Obesity Clinical Trial

— COMPARE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01127230
• Other study ID #: 01-2010/03/14-S0001
• Status: Completed
• Phase: N/A
• First received: May 19, 2010
• Last updated: July 16, 2010
• Start date: March 2010
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Novena Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Centre for Research Excellence, Aesthetic Training and Education
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Singapore	Life Source Medical Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Novena Medical Center

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stromal Vascular Fraction Cell Count Ratio	SVF cell count Ratio = SVF cell count from Cytori's Celution : SVF cell count from manual preparation	1 day	No
Secondary	Stromal Vascular Fraction Cell Count Age Comparison .	SVF cell counts differences in different age groups	1 day	No