Reparation of Cartilage Injuries in the Human Knee by Imp... | NCT00263432

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

NCT00263432

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Dec 9, 2022Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cartilage Injuries in the Human Knee

Interventions

Human allogenic chondrocytes

Countries

Belgium

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

Dec 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2011Actual

Primary Completion Date

Jul 1, 2015Actual

Completion Date

Jul 1, 2015Actual

First Submitted Date

Dec 4, 2005

First Submission Date that Met QC Criteria

Dec 6, 2005

First Posted Date

Dec 8, 2005Estimated

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

Dec 6, 2022

Last Update Posted Date

Dec 9, 2022Actual

Name	Class
University Ghent	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Description Module

Brief Summary

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

Detailed Description

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Implantation of fresh human allogenic chondrocytes	Procedure: Human allogenic chondrocytes

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Human allogenic chondrocytes	Procedure	Implantation of fresh human allogenic chondrocytes in human knee cartilage injuries	1

Measure	Description	Time Frame
Healing of the cartilage injuries		After 2 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Important cartilage injury in the knee

Exclusion Criteria:

Important axis deviation
Inflammatory joint disorder
Severe obesity

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karl Fredrik Almqvist, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium