Depressed ScarPhase 2/3NCT00992147
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
A Phase 2/3 study testing Adipocell in people with Depressed Scar, run by Anterogen Co., Ltd. at 1 site in South Korea.
Trial summary
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Depressed Scar
- What is being tested?
- Adipocell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2004to Mar 2007
- Phase
- Phase 2/3
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- older than 19 years
- depressed scar less than volume of 5 ml
- negative for urine beta-HCG for women of childbearing age
- agreement to participate, with signed informed-consent
Who cannot join
- failure to meet inclusion criteria
- any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
- allergy to bovine-derived materials
- Diagnosis of cancer, AIDS, HBV or HCV.
- Patient has a lot of hairs or a tattoo on depressed site
- Insufficient adipose tissue for manufacturing of ANTG-adip
- Patient has depressed scar caused by a malignant tumor
- Patient whom investigator consider is not suitable in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.
- Conditions
- Depressed Scar
- Being tested
- Adipocell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdipocellDrug
autologous cultured adipocytes (ANTG-adip)
| Study group | Role | What they receive |
|---|---|---|
| autologous cultured adipocytes | Experimental | Not described Receives: Drug: Adipocell |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy: recovery rate(%)
Measured: week 12
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Secondary outcomes (3)
Recovery rate (%)
Measured: day 7, 14, 21, 28 days and week 8
A digital photograph
Measured: day 1, 3, 7, 14, 21, 28, week 8 and week 12
Patient satisfaction
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startMay 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressed ScarStudies 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
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anterogen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gab-sung Oh, M.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992147
- Sponsor's protocol ID
- ANTG-adip-301
- Status last verified
- Oct 2009
- First submitted
- 28 Sep 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00992147
- Acronym / sponsor ID
- ANTG-adip-301
- Conditions
- Depressed Scar
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Anterogen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2004
- Study completion
- Mar 2007 (actual)
- First posted
- 9 Oct 2009 (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.
Autologous cultured adipocytes (ANTG-adip) is produced by well-established techniques including cell harvesting from lipoaspirates, expansion of adipose tissue derived stem cells, and differentiation into pure and immature adipocytes. This was an open-label, dose-escalation study. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous cultured adipocytes | Experimental | Drug: Adipocell |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- older than 19 years
- depressed scar less than volume of 5 ml
- negative for urine beta-HCG for women of childbearing age
- agreement to participate, with signed informed-consent
Key exclusion criteria (8 listed)
- failure to meet inclusion criteria
- any immune-suppressive drug, corticosteroid or cytotoxic drug within the previous 30 days
- allergy to bovine-derived materials
- Diagnosis of cancer, AIDS, HBV or HCV.
- Patient has a lot of hairs or a tattoo on depressed site
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adipocellautologous cultured adipocytes (ANTG-adip) | Drug | autologous cultured adipocytes |
Primary outcome
Efficacy: recovery rate(%)
Time frame: week 12
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
3 secondary outcomes
Recovery rate (%)
Time frame: day 7, 14, 21, 28 days and week 8
A digital photograph
Time frame: day 1, 3, 7, 14, 21, 28, week 8 and week 12
Patient satisfaction
Time frame: week 12
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 9 Oct 2009.
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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.
Gab-sung Oh, M.D principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Adipocell in people with Depressed Scar, run by Anterogen Co., Ltd. at 1 site in South Korea.
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 4 inclusion and 8 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 9 Oct 2009. 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 South Korea. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy: recovery rate(%) (time frame: week 12). The study lists 2 primary outcomes in all. 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 9 Oct 2009.