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
  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:


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
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

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 July 31, 2014