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

Biosolution

Status and phase: Unknown; Phase 3

Conditions: Burn Wound

Treatments: Drug: Autologous cultured keratinocyte cell

Study type: Interventional

Funder types: Industry

Identifiers

NCT00978705

MCTT-KRH-06

Details and patient eligibility

About

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

Enrollment: 19 estimated patients

Sex: All

Ages: 1 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)