Clinical Efficacy and Safety of Autologous Cultured Kerat... | NCT00978705

Studies
Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

NCT00978705

Sponsor

Biosolution Co., Ltd.

Status

Unknown status

Last Update Posted

Sep 17, 2009Estimated

Enrollment

19Estimated

Phase

Phase 3

Conditions

Burn Wound

Interventions

Autologous cultured keratinocyte cell

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2007

Primary Completion Date

May 2008Estimated

Completion Date

Jan 2010Estimated

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Sep 15, 2009

First Posted Date

Sep 17, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2009

Last Update Posted Date

Sep 17, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

19Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Autologous cultured keratinocyte cell	Drug	3x10^7 cell/ vial		Keraheal

Measure	Description	Time Frame
engraftment assessment		4week

Measure	Description	Time Frame
the vancouver burn scar scale		8, 12, 24 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wook Chun, MD	Hangang Sacred Heart Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hangang Sacred Heart Hospital		Seoul		150-030	South Korea