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

Phase 3

• Conditions: Burn Wound

• Registration Number: NCT00978705
• Lead Sponsor: Biosolution Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2008-05
• Study First Submitted: 2009-04-15
• Status Verified: 2009-09
• Study First Submitted QC: 2009-09-15
• Last Update Submitted: 2009-09-15
• Study First Posted: 2009-09-17
• Last Update Posted: 2009-09-17
• Study Completion: 2010-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
engraftment assessment	4week

Secondary Outcome Measures

Name	Time	Method
the vancouver burn scar scale	8, 12, 24 week

Trial Locations

Locations (1)

Hangang Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of