Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
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ClinicalTrials.gov Identifier: NCT00992147 |
Recruitment Status :
Completed
First Posted : October 9, 2009
Last Update Posted : October 9, 2009
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressed Scar | Drug: Adipocell | Phase 2 Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 36 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy |
Study Start Date : | May 2004 |
Actual Study Completion Date : | March 2007 |

Arm | Intervention/treatment |
---|---|
Experimental: autologous cultured adipocytes |
Drug: Adipocell
autologous cultured adipocytes (ANTG-adip) |
- Efficacy: recovery rate(%) [ Time Frame: week 12 ]
- Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
- 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 ]

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Ages Eligible for Study: | 19 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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

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): NCT00992147
Korea, Republic of | |
Samsung Medical Center | |
Seoul, Korea, Republic of, 135-710 |
Principal Investigator: | Gab-sung Oh, M.D | Samsung Medical Center |
ClinicalTrials.gov Identifier: | NCT00992147 |
Other Study ID Numbers: |
ANTG-adip-301 |
First Posted: | October 9, 2009 Key Record Dates |
Last Update Posted: | October 9, 2009 |
Last Verified: | October 2009 |
Consciousness Disorders Depression Behavioral Symptoms Neurobehavioral Manifestations |
Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders |