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

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ClinicalTrials.gov Identifier: NCT00978705
Recruitment Status : Unknown
Verified September 2009 by Biosolution Co., Ltd..
Recruitment status was:  Enrolling by invitation
First Posted : September 17, 2009
Last Update Posted : September 17, 2009
Sponsor:
Information provided by:
Biosolution Co., Ltd.

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

Condition or disease Intervention/treatment Phase
Burn Wound Drug: Autologous cultured keratinocyte cell Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 19 participants
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
Study Start Date : November 2007
Estimated Primary Completion Date : May 2008
Estimated Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Drug: Autologous cultured keratinocyte cell
    3x10^7 cell/ vial
    Other Name: Keraheal


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

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


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

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

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 Posted: September 17, 2009    Key Record Dates
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