Back to resultsSafety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
Primary Purpose
Depressed Scar
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Adipocell
Sponsored by
About this trial
This is an interventional treatment trial for Depressed Scar
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
autologous cultured adipocytes
Arm Description
Outcomes
Primary Outcome Measures
Efficacy: recovery rate(%)
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Secondary Outcome Measures
Recovery rate (%)
A digital photograph
Patient satisfaction
Full Information
NCT ID
NCT00992147
First Posted
September 28, 2009
Last Updated
October 8, 2009
Sponsor
Anterogen Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00992147
Brief Title
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
Official Title
A Phase II/III Clinical Study of ANTG-adip for the Treatment of Depressed Scar to Evaluate Safety and Efficacy
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
May 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Anterogen Co., Ltd.
4. Oversight
5. Study Description
Brief 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. Patients are given subcutaneous injection of ANTG-adip and followed for 12 weeks according to the clinical trial protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressed Scar
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous cultured adipocytes
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Adipocell
Intervention Description
autologous cultured adipocytes (ANTG-adip)
Primary Outcome Measure Information:
Title
Efficacy: recovery rate(%)
Time Frame
week 12
Title
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test
Secondary Outcome Measure Information:
Title
Recovery rate (%)
Time Frame
day 7, 14, 21, 28 days and week 8
Title
A digital photograph
Time Frame
day 1, 3, 7, 14, 21, 28, week 8 and week 12
Title
Patient satisfaction
Time Frame
week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gab-sung Oh, M.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
12. IPD Sharing Statement
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Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar
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