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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2009 by Biosolution Co., Ltd..
Recruitment status was:  Enrolling by invitation
Sponsor:
ClinicalTrials.gov Identifier:
NCT00978705
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Biosolution Co., Ltd.
  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: Intervention Model: Single Group Assignment
Masking: None (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 Biosolution Co., Ltd.:

Primary Outcome Measures:
  • engraftment assessment [ Time Frame: 4week ]

Secondary Outcome Measures:
  • the vancouver burn scar scale [ Time Frame: 8, 12, 24 week ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00978705


Locations
Korea, Republic of
Hangang Sacred Heart Hospital
Seoul, Korea, Republic of, 150-030
Sponsors and Collaborators
Biosolution Co., Ltd.
Investigators
Principal Investigator: Wook Chun, MD Hangang Sacred Heart Hospital
  More Information

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
First Submitted: April 15, 2009
First Posted: September 17, 2009
Last Update Posted: September 17, 2009
Last Verified: September 2009

Keywords provided by Biosolution Co., Ltd.:
Keratinocyte Cell
severe burn wound

Additional relevant MeSH terms:
Burns
Wounds and Injuries