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

Phase 3UnknownNCT00978705

Biosolution Co., Ltd.19 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Burn Wound

Interventions

Autologous cultured keratinocyte cellDRUG

3x10\^7 cell/ vial

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Hangang Sacred Heart Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

engraftment assessment

Time frame: 4week

Secondary Outcomes

the vancouver burn scar scale

Time frame: 8, 12, 24 week

Data from ClinicalTrials.gov

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