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

This study has been completed.

Sponsor:

Information provided by:

Anterogen Co., Ltd.

ClinicalTrials.gov Identifier:

NCT00992147

First received: September 28, 2009

Last updated: October 8, 2009

Last verified: October 2009

History of Changes

Purpose

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.

Condition	Intervention	Phase
Depressed Scar	Drug: Adipocell	Phase 2 Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

MedlinePlus related topics: Scars

U.S. FDA Resources

Further study details as provided by Anterogen Co., Ltd.:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	36
Study Start Date:	May 2004
Study Completion Date:	March 2007

Arms	Assigned Interventions
Experimental: autologous cultured adipocytes	Drug: Adipocell autologous cultured adipocytes (ANTG-adip)

Eligibility


Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00992147

Locations


Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710

Sponsors and Collaborators

Anterogen Co., Ltd.

Investigators


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

More Information


ClinicalTrials.gov Identifier:	NCT00992147 History of Changes
Other Study ID Numbers:	ANTG-adip-301
Study First Received:	September 28, 2009
Last Updated:	October 8, 2009

Additional relevant MeSH terms:


Depression Behavioral Symptoms

ClinicalTrials.gov processed this record on August 22, 2017

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