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Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00263432
First received: December 4, 2005
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis


Condition Intervention
Cartilage Injuries in the Human Knee
 Procedure: Human allogenic chondrocytes

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Healing of the cartilage injuries [ Time Frame: After 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: August 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Implantation of fresh human allogenic chondrocytes
 Procedure: Human allogenic chondrocytes
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Important cartilage injury in the knee

Exclusion Criteria:

  • Important axis deviation
  • Inflammatory joint disorder
  • Severe obesity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00263432

Contacts
Contact: Karl Fredrik Almqvist, MD, PhD fredrik.almqvist@UGent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Karl Fredrik Almqvist, MD, PhD         fredrik.almqvist@UGent.be    
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
Investigators
Principal Investigator: Karl Fredrik Almqvist, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00263432     History of Changes
Other Study ID Numbers: 2001/245
Study First Received: December 4, 2005
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013