Trial | NCT00978705  Report issue

Title

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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    19
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
Study Started
Nov 30
2007
Primary Completion
May 31
2008
Anticipated
Study Completion
Jan 31
2010
Anticipated
Last Update
Sep 17
2009
Estimate

Drug Autologous cultured keratinocyte cell

3x10^7 cell/ vial

  • Other names: Keraheal

Criteria 

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
No Results Posted