NCT00978705

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

September 17, 2009

Status Verified

September 1, 2009

Enrollment Period

6 months

First QC Date

April 15, 2009

Last Update Submit

September 15, 2009

Conditions

Burn Wound

Keywords

Keratinocyte Cellsevere burn wound

Outcome Measures

Primary Outcomes (1)

  • engraftment assessment

    4week

Secondary Outcomes (1)

  • the vancouver burn scar scale

    8, 12, 24 week

Interventions

Autologous cultured keratinocyte cellDRUG

3x10\^7 cell/ vial

Also known as: Keraheal

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangang Sacred Heart Hospital

Seoul, 150-030, South Korea

Location

MeSH Terms

Conditions

Burns

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Wook Chun, MD

    Hangang Sacred Heart Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 15, 2009

First Posted

September 17, 2009

Study Start

November 1, 2007

Primary Completion

May 1, 2008

Study Completion

January 1, 2010

Last Updated

September 17, 2009

Record last verified: 2009-09

Locations

KR(1)