ObesityCOMPARENCT01127230
Comparison Between Celution Preparation and Manual Preparation of Adipocyte Derived Regenerative Cells, Using Stromal Vascular Fraction Cell Counts (COMPARE)
An observational study of Obesity, run by Novena Medical Center at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Mar 2010to Jul 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Liposuction Patients
Who may be able to join
- patients who already opted for liposuction
- patients who consents to donate the lipoaspirate after liposuction
- patients more than 21 years of age
Who cannot join
- patients with history of organ failure
- patients with history of carcinoma
- patients who are pregnant
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Obesity
- Keywords
- 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.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Liposuction patients | Patients who already opted and are scheduled for liposuction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stromal Vascular Fraction Cell Count Ratio
SVF cell count Ratio = SVF cell count from Cytori's Celution : SVF cell count from manual preparation
Measured: 1 day
Secondary outcomes (1)
Stromal Vascular Fraction Cell Count Age Comparison .
SVF cell counts differences in different age groups
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Novena Medical Center
- Sponsor type
- Research network
- Investigators
- Kok Leong Tan, MBBS, Principal investigator, Life Source Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127230
- Sponsor's protocol ID
- 01-2010/03/14-S0001
- Acronym
- COMPARE
- Status last verified
- Jul 2010
- First submitted
- 19 May 2010
- Last updated
- 19 Jul 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Celution Preparation and Manual Preparation of Adipocyte Derived Regenerative Cells, Using Stromal Vascular Fraction Cell Counts (COMPARE)
- ClinicalTrials.gov ID
- NCT01127230
- Acronym / sponsor ID
- COMPARE / 01-2010/03/14-S0001
- Conditions
- Obesity
- Keywords
- 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.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Novena Medical CenterResearch network
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 20 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Liposuction patients | – | –Patients who already opted and are scheduled for liposuction. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Liposuction Patients
Key inclusion criteria (3 listed)
- patients who already opted for liposuction
- patients who consents to donate the lipoaspirate after liposuction
- patients more than 21 years of age
Key exclusion criteria (3 listed)
- patients with history of organ failure
- patients with history of carcinoma
- patients who are pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 secondary outcome
Stromal Vascular Fraction Cell Count Age Comparison .
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kok Leong Tan, MBBS principal investigator
Life Source Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Novena Medical Center at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stromal Vascular Fraction Cell Count Ratio (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2010.