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

October 8, 2009 updated by: Anterogen Co., Ltd.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: autologous cultured adipocytes
Drug: Adipocell
autologous cultured adipocytes (ANTG-adip)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Recovery rate (%)
Time Frame: day 7, 14, 21, 28 days and week 8
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
day 1, 3, 7, 14, 21, 28, week 8 and week 12
Patient satisfaction
Time Frame: week 12
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anterogen Co., Ltd.

Investigators

  • Principal Investigator: Gab-sung Oh, M.D, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

September 28, 2009

First Submitted That Met QC Criteria

October 8, 2009

First Posted (Estimate)

October 9, 2009

Study Record Updates

Last Update Posted (Estimate)

October 9, 2009

Last Update Submitted That Met QC Criteria

October 8, 2009

Last Verified

October 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANTG-adip-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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