INSTRUCT for Repair of Knee Cartilage Defects

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
CellCoTec B.V.
ClinicalTrials.gov Identifier:
NCT01041885
First received: December 31, 2009
Last updated: October 1, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Articular Cartilage Lesion of the Knee
Device: INSTRUCT

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects

Further study details as provided by CellCoTec B.V.:

Primary Outcome Measures:
  • Incidence of related adverse events [ Time Frame: Over 24 months ] [ Designated as safety issue: Yes ]
  • Lesion filling [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence of non-related adverse events [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
  • KOOS, IKDC and pain VAS scores [ Time Frame: At all timepoints over 24 months ] [ Designated as safety issue: No ]
  • Histopathology assessments [ Time Frame: 6 or 12 months ] [ Designated as safety issue: No ]
  • MRI evaluation of structural repair [ Time Frame: Discharge, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
  • dGEMRIC assessment of structural repair [ Time Frame: 6, 12 and 24 months ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2010
Estimated Study Completion Date: June 2014
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INSTRUCT
INSTRUCT scaffold implantation
Device: INSTRUCT
INSTRUCT PolyActive scaffold implantation

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).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01041885

Locations
Belgium
University Hospital Gent
Gent, Belgium
Poland
University Hospital nber 2 Dr. Jana Biziela
Bydgoszcz, Poland
NZOZ "Szpital AVIMED" sp. z o.o.
Katowice, Poland
NZOZ Endomedical
Poznan, Poland
Centrum Medycyny Sportowej (Sports Medicine Center CMS)
Warsaw, Poland
United Kingdom
Royal Orthopaedic Hospital
Birmingham, United Kingdom
Sponsors and Collaborators
CellCoTec B.V.
Investigators
Study Director: Joël Guidoux CellCoTec B.V.
  More Information

No publications provided

Responsible Party: CellCoTec B.V.
ClinicalTrials.gov Identifier: NCT01041885     History of Changes
Other Study ID Numbers: 309-019
Study First Received: December 31, 2009
Last Updated: October 1, 2013
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products

Keywords provided by CellCoTec B.V.:
knee cartilage defect repair
cartilage lesion
autologous chondrocyte
scaffold
INSTRUCT

ClinicalTrials.gov processed this record on August 26, 2014