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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014