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

• Status: Unknown status
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Biosolution Co., Ltd.; Modern Cell and Tissue Technology

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