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

NCT ID: NCT00978705

Last Updated: 2009-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2010-01-31

Brief Summary

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

Detailed Description

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Conditions

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Burn Wound

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Autologous cultured keratinocyte cell

3x10\^7 cell/ vial

Intervention Type DRUG

Other Intervention Names

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Keraheal

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Biosolution Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Modern Cell and Tissue Technology

Principal Investigators

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Wook Chun, MD

Role: PRINCIPAL_INVESTIGATOR

Hangang Sacred Heart Hospital

Locations

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Hangang Sacred Heart Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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MCTT-KRH-06

Identifier Type: -

Identifier Source: org_study_id

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