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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00992147
First Posted: October 9, 2009
Last Update Posted: October 9, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Anterogen Co., Ltd.
  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:


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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

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


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
First Submitted: September 28, 2009
First Posted: October 9, 2009
Last Update Posted: October 9, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Depression
Behavioral Symptoms