Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood (keratinocyte)

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Modern Cell and Tissue Technology
ClinicalTrials.gov Identifier:
NCT00978705
First received: April 15, 2009
Last updated: September 15, 2009
Last verified: September 2009

April 15, 2009
September 15, 2009
November 2007
May 2008   (final data collection date for primary outcome measure)
engraftment assessment [ Time Frame: 4week ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00978705 on ClinicalTrials.gov Archive Site
the vancouver burn scar scale [ Time Frame: 8, 12, 24 week ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.

Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Burn Wound
Drug: Autologous cultured keratinocyte cell
3x10^7 cell/ vial
Other Name: Keraheal
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
19
January 2010
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age : 1~70 years
  • More than 30% TBSA of second degree burn or more than 10% TBSA of third degree burn
  • Must provide signed informed consent prior to participation in any study-related procedures

Exclusion Criteria:

  • Have a pyogenic infection
  • Part of the facial cosmetic surgery cost
  • Hypersensitivity reactions in patients with bovine proteins
  • Hypersensitivity reactions in patients with Gentamycin
  • Pregnancy or lactation
Both
1 Year to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00978705
MCTT-KRH-06
Yes
Yunyoung Kim / Senior Research Scientist, Modern Cell and Tissue Technology
Modern Cell and Tissue Technology
Not Provided
Principal Investigator: Wook Chun, MD Hangang Sacred Heart Hospital
Modern Cell and Tissue Technology
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP