Back to resultsReparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Primary Purpose
Cartilage Injuries in the Human Knee
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Human allogenic chondrocytes
Sponsored by
About this trial
This is an interventional treatment trial for Cartilage Injuries in the Human Knee
Eligibility Criteria
Inclusion Criteria: Important cartilage injury in the knee Exclusion Criteria: Important axis deviation Inflammatory joint disorder Severe obesity
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Implantation of fresh human allogenic chondrocytes
Outcomes
Primary Outcome Measures
Healing of the cartilage injuries
Secondary Outcome Measures
Full Information
NCT ID
NCT00263432
First Posted
December 4, 2005
Last Updated
December 6, 2022
Sponsor
University Hospital, Ghent
Collaborators
University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT00263432
Brief Title
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Official Title
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2011 (Actual)
Primary Completion Date
July 1, 2015 (Actual)
Study Completion Date
July 1, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
University Ghent
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries to obtain a repair and prevention of secondary osteoarthritis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cartilage Injuries in the Human Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Implantation of fresh human allogenic chondrocytes
Intervention Type
Procedure
Intervention Name(s)
Human allogenic chondrocytes
Intervention Description
Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries
Primary Outcome Measure Information:
Title
Healing of the cartilage injuries
Time Frame
After 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Important cartilage injury in the knee
Exclusion Criteria:
Important axis deviation
Inflammatory joint disorder
Severe obesity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl Fredrik Almqvist, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Links:
URL
http://www.uzgent.be
Description
Website of the University Hospital Ghent
Learn more about this trial
Reparation of Cartilage Injuries in the Human Knee by Implantation of Fresh Human Allogenic Chondrocytes
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