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NCT00978705 Clinical Trial

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

Burn Wound Clinical Trial

— keratinocyte  

Official title:
Clinical Study for Evaluation of Clinical Efficacy and Safety of Autologous Cultured Keratinocyte Cell on Severe Burn Wood

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT00978705
Other study ID # MCTT-KRH-06
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received April 15, 2009
Last updated September 15, 2009
Start date November 2007
Est. completion date January 2010

Study information
Verified date September 2009
Source Modern Cell and Tissue Technology
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 19
Est. completion date January 2010
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 1 Year to 70 Years
Eligibility 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Autologous cultured keratinocyte cell
3x10^7 cell/ vial

Locations
Country Name City State
Korea, Republic of Hangang Sacred Heart Hospital Seoul

Sponsors (1)
Lead Sponsor Collaborator
Modern Cell and Tissue Technology

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary engraftment assessment 4week Yes
Secondary the vancouver burn scar scale 8, 12, 24 week Yes
See also
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Active, not recruiting NCT05341427 - DEVELOPMENT OF A CLINICAL PREDICTION RULES TO IDENTIFY EFFICACY OF PULSED ELECTROMAGNETIC THERAPY ON BURN WOUND HEALING N/A
Completed NCT04753723 - The Use of a Platform Wound Device for Reducing Infection Phase 4
Terminated NCT03723590 - A Clinical Evaluation of an Esterified Hyaluronic Acid Matrix in Burn Patients for STSG N/A
Not yet recruiting NCT04011306 - A Feasibility Study of a Novel Phototherapy System for the Management of Acute Burns N/A
Recruiting NCT05404191 - Prediction Rules for Low Level Laser on Burn Wounds N/A
Completed NCT02982096 - Study Comparing Healing With Epidermal Fractional Blistergrafting (CellutomeTM) to Acellular Technique N/A

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