INSTRUCT for Repair of Knee Cartilage Defects | NCT01041885

Studies
INSTRUCT for Repair of Knee Cartilage Defects

NCT01041885

Sponsor

CellCoTec B.V.

Status

Completed

Last Update Posted

Feb 4, 2015Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Articular Cartilage Lesion of the Knee

Interventions

INSTRUCT

Countries

Belgium
Poland
United Kingdom

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

Feb 2015

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

Jan 2010

Primary Completion Date

Sep 2012Actual

Completion Date

Jun 2014Actual

First Submitted Date

Dec 31, 2009

First Submission Date that Met QC Criteria

Dec 31, 2009

First Posted Date

Jan 1, 2010Estimated

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

Feb 2, 2015

Last Update Posted Date

Feb 4, 2015Estimated

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

The purpose of this study is to investigate whether the INSTRUCT therapy is safe and effective in the treatment of cartilage defects of the knee.

Detailed Description

This is a prospective, open-label, single-arm pilot study designed to investigate the safety and efficacy of the INSTRUCT therapy in the treatment of knee cartilage defects.

All patients who meet eligibility criteria and who consent to participate will undergo the implantation of a biodegradable scaffold seeded with autologous primary chondrocytes and bone marrow cells via arthrotomy.

Patients will be followed-up for 2 years at regular intervals. Evaluations will include adverse events collection, patient reported outcomes (mostly pain and function), arthroscopic and histologic evaluations and MRIs (including dGEMRIC).

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

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
INSTRUCT	Experimental	INSTRUCT scaffold implantation	Device: INSTRUCT

Interventions

Name	Type	Description	Arm Group Labels	Other Names
INSTRUCT	Device	INSTRUCT PolyActive scaffold implantation	INSTRUCT

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of related adverse events		Over 24 months
Lesion filling		3 months

Secondary Outcomes

Measure	Description	Time Frame
Incidence of non-related adverse events		24 months
KOOS, IKDC and pain VAS scores		At all timepoints over 24 months
Histopathology assessments

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a symptomatic articular cartilage defect in the knee

Exclusion Criteria:

Surgery on the study knee joint within 6 months
Patients with significant malalignment (more than 5°)
Patients with ligamentous instability of the knee
Majority of the meniscus absent
Severe osteoarthritis
Intake of medications or treatments having an effect on bone or cartilage formation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joël Guidoux	CellCoTec B.V.	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Gent		Ghent			Belgium
University Hospital nber 2 Dr. Jana Biziela

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32267734	Derived	Slynarski K, de Jong WC, Snow M, Hendriks JAA, Wilson CE, Verdonk P. Single-Stage Autologous Chondrocyte-Based Treatment for the Repair of Knee Cartilage Lesions: Two-Year Follow-up of a Prospective Single-Arm Multicenter Study. Am J Sports Med. 2020 May;48(6):1327-1337. doi: 10.1177/0363546520912444. Epub 2020 Apr 8.