Back to resultsClinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood (keratinocyte)
Primary Purpose
Burn Wound
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Autologous cultured keratinocyte cell
Sponsored by
About this trial
This is an interventional treatment trial for Burn Wound focused on measuring Keratinocyte Cell, severe burn wound
Eligibility 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
Sites / Locations
- Hangang Sacred Heart Hospital
Outcomes
Primary Outcome Measures
engraftment assessment
Secondary Outcome Measures
the vancouver burn scar scale
Full Information
NCT ID
NCT00978705
First Posted
April 15, 2009
Last Updated
September 15, 2009
Sponsor
Biosolution Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00978705
Brief Title
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Acronym
keratinocyte
Official Title
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2008 (Anticipated)
Study Completion Date
January 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Biosolution Co., Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The efficacy and safety of Autologous cultured keratinocyte cell on severe burn wound.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burn Wound
Keywords
Keratinocyte Cell, severe burn wound
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
19 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Autologous cultured keratinocyte cell
Other Intervention Name(s)
Keraheal
Intervention Description
3x10^7 cell/ vial
Primary Outcome Measure Information:
Title
engraftment assessment
Time Frame
4week
Secondary Outcome Measure Information:
Title
the vancouver burn scar scale
Time Frame
8, 12, 24 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wook Chun, MD
Organizational Affiliation
Hangang Sacred Heart Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangang Sacred Heart Hospital
City
Seoul
ZIP/Postal Code
150-030
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood
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