Non-Interventional Study to Evaluate Safety and Efficacy of NOVOCART 3D in Patients With Cartilage Defects (NISANIK)

Tissue Engineering Technologies (TETEC)

Status: Completed

Conditions: Cartilage Diseases

Treatments: Biological: NOVOCART 3D

Study type: Observational

Funder types: Industry

Identifiers

NCT02348697

2015-000166-62 (EudraCT Number)

AAG-O-H-1418

Details and patient eligibility

About

Non-interventional study to evaluate safety and efficacy of NOVOCART 3D in adult and adolescent patients with full thickness cartilage defects after the treatment with NOVOCART 3D.

Full description

A 36-month post treatment follow up of adverse and serious adverse effects as well as the measurement of efficacy with the International Knee Documentation Committee (IKDC) Score.

Enrollment: 81 patients

Sex: All

Ages: 14 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male and female adult patients
• Children and adolescents with closed epiphysial plate
• Defect size ≥2.5 and ≤10 cm2 post-debridement
• Localized full thickness articular cartilage defect of the knee (Grade 3 & 4 International Cartilage Repair Society (ICRS) classification)

Exclusion criteria

• Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren and Lawrence grade >2
• More than 2 defects or 2 corresponding lesions
• Ankylosis
• Arthrofibrosis
• Diffuse chondromalacia
• Total/subtotal resected meniscus
• Insufficient Ligament guidance
• Patella malignement
• Inflammatory joint disease
• General cartilage degeneration or increased joint deterioration
• Cancer, present or within the last 5 years
• Primary treatment in children and adolescents with open epiphysial plate
• Chronical infection diseases
• Untreated coagulation disorder
• Pregnancy and lactating
• Known history of allergies against ingredients of NOVOCART® 3D