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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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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: Depression Scars
U.S. FDA Resources

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

Primary Outcome Measures:
  • Efficacy: recovery rate(%) [ Time Frame: week 12 ] [ Designated as safety issue: Yes ]
  • 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)
Other Name: Adipocell

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Korea: Food and Drug Administration

Additional relevant MeSH terms:
Cicatrix
Depression
Fibrosis
Pathologic Processes
Behavioral Symptoms

ClinicalTrials.gov processed this record on May 19, 2013