Clinical trial NCT01041885: INSTRUCT for Repair of Knee Cartilage Defects
Official title: Prospective Feasibility, Non-randomized, Single Arm Multicentre, Multinational Interventional Clinical Investigation Using INSTRUCT Therapy for the Repair of Knee Cartilage Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Articular Cartilage Lesion of the Knee
Keywords: knee cartilage defect repair
cartilage lesion
autologous chondrocyte
scaffold
INSTRUCT
Lead sponsor: CellCoTec B.V.
Sponsor class: INDUSTRY
First posted: 2010-01-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Incidence of related adverse events
timeFrame: Over 24 months
measure: Lesion filling
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of non-related adverse events
timeFrame: 24 months
measure: KOOS, IKDC and pain VAS scores
timeFrame: At all timepoints over 24 months
measure: Histopathology assessments
timeFrame: 6 or 12 months
measure: MRI evaluation of structural repair
timeFrame: Discharge, 3, 6, 12 and 24 months
measure: dGEMRIC assessment of structural repair
timeFrame: 6, 12 and 24 months
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: University Hospital Gent
city: Bydgoszcz
country: Poland
facility: University Hospital nber 2 Dr. Jana Biziela
city: Katowice
country: Poland
facility: NZOZ "Szpital AVIMED" sp. z o.o.
city: Poznan
country: Poland
facility: NZOZ Endomedical
city: Warsaw
country: Poland
facility: Centrum Medycyny Sportowej (Sports Medicine Center CMS)
city: Birmingham
country: United Kingdom
facility: Royal Orthopaedic Hospital
Study officials:
affiliation: CellCoTec B.V.
name: Joël Guidoux
role: STUDY_DIRECTOR
References:
citation: 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.