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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Modern Cell and Tissue Technology
ClinicalTrials.gov Identifier:
NCT00978705
First received: April 15, 2009
Last updated: September 15, 2009
Last verified: September 2009
  Purpose

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


Condition Intervention Phase
Burn Wound
Drug: Autologous cultured keratinocyte cell
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

Resource links provided by NLM:


Further study details as provided by Modern Cell and Tissue Technology:

Primary Outcome Measures:
  • engraftment assessment [ Time Frame: 4week ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • the vancouver burn scar scale [ Time Frame: 8, 12, 24 week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 19
Study Start Date: November 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Autologous cultured keratinocyte cell
    3x10^7 cell/ vial
    Other Name: Keraheal
  Eligibility

Ages Eligible for Study:   1 Year to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00978705

Locations
Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of, 150-030
Sponsors and Collaborators
Modern Cell and Tissue Technology
Investigators
Principal Investigator: Wook Chun, MD Hangang Sacred Heart Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Yunyoung Kim / Senior Research Scientist, Modern Cell and Tissue Technology
ClinicalTrials.gov Identifier: NCT00978705     History of Changes
Other Study ID Numbers: MCTT-KRH-06
Study First Received: April 15, 2009
Last Updated: September 15, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Modern Cell and Tissue Technology:
Keratinocyte Cell
severe burn wound

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on April 17, 2014