Safety and Efficacy of Autologous Cultured Adipocytes in... | NCT00992147

Studies
Safety and Efficacy of Autologous Cultured Adipocytes in Patient With Depressed Scar

NCT00992147

Sponsor

Anterogen Co., Ltd.

Status

Completed

Last Update Posted

Oct 9, 2009Estimated

Enrollment

36Actual

Phase

Phase 2Phase 3

Conditions

Depressed Scar

Interventions

Adipocell

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Not provided

Completion Date

Mar 2007Actual

First Submitted Date

Sep 28, 2009

First Submission Date that Met QC Criteria

Oct 8, 2009

First Posted Date

Oct 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 8, 2009

Last Update Posted Date

Oct 9, 2009Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
autologous cultured adipocytes	Experimental		Drug: Adipocell

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adipocell	Drug	autologous cultured adipocytes (ANTG-adip)	autologous cultured adipocytes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy: recovery rate(%)		week 12
Safety: clinically measured abnormality of laboratory tests and adverse events, Injection site observation, Immune rejection test

Secondary Outcomes

Measure	Description	Time Frame
Recovery rate (%)		day 7, 14, 21, 28 days and week 8
A digital photograph		day 1, 3, 7, 14, 21, 28, week 8 and week 12
Patient satisfaction

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Gab-sung Oh, M.D	Samsung Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Samsung Medical Center		Seoul		135-710	South Korea