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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00978705

Acronym

keratinocyte

Enrollment

Registered

2009-09-17

Start date

2007-11-30

Completion date

2010-01-31

Last updated

2009-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Burn Wound

Keywords

Keratinocyte Cell, severe burn wound

Brief summary

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

Interventions

DRUGAutologous cultured keratinocyte cell

3x10\^7 cell/ vial

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Years to 70 Years

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

Design outcomes

Primary

Measure	Time frame
engraftment assessment	4week

Secondary

Measure	Time frame
the vancouver burn scar scale	8, 12, 24 week

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026