Status:

UNKNOWN

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

Lead Sponsor:

Biosolution Co., Ltd.

Conditions:

Burn Wound

Eligibility:

All Genders

1-70 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

January 1 2010

Estimated Enrollment :

19 Patients enrolled

Trial Details

Trial ID

NCT00978705

Start Date

November 1 2007

End Date

January 1 2010

Last Update

September 17 2009

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Hangang Sacred Heart Hospital

Seoul, South Korea, 150-030

Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood | DecenTrialz