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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02348697

Acronym

NISANIK

Enrollment

Registered

2015-01-28

Start date

2015-06-30

Completion date

2019-10-30

Last updated

2019-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cartilage Diseases

Keywords

Cartilage Defect in the Knee, MACT

Brief summary

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.

Detailed 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.

Interventions

BIOLOGICALNOVOCART 3D

Autologous Chondrocyte Implantation

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

14 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Safety - Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety	36 month	Number of Adverse Drug Reaction/Serious Adverse Drug Reaction as a Measure of Safety

Secondary

Measure	Time frame	Description
Efficacy - International Knee Documentation Committee (IKDC) 2000	36 month	International Knee Documentation Committee (IKDC) 2000

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026