LENZUMESTROCEL for Articular cartilage defect

Inclusion criteria

• {"criterion_text":"- Adult patients of either sex, age between 18 and 55 years."}
• {"criterion_text":"- Able to provide written informed consent."}
• {"criterion_text":"- Confirmed diagnosis of chondral defects of the weight bearing compartment of the knee joint up to the radiologically confirmed knee osteoarthrosis stage II (according to Kellgren classification), the cause of the defect being either trauma or incipient degeneration."}
• {"criterion_text":"- Defect is located in the weigh-bearing part of femoral condyle."}
• {"criterion_text":"- Scheduled to undergo an open surgery of the knee for the chondral defect management (namely microfracture of the subchondral bone followed by the application of a 3D scaffold)."}
• {"criterion_text":"- Isolated chondral defect with a maximum size of 6 cm2."}
• {"criterion_text":"- No previous knee surgery due to a treatment of a chondral defect."}
• {"criterion_text":"- Preoperative level of hemoglobin at least 110 g per L."}
• {"criterion_text":"- Preoperative level of platelet count higher than 150 000 per mL."}
• {"criterion_text":"- Sexually active, nonsterile female patients need to use highly effective contraception during the whole study."}

Exclusion criteria

• {"criterion_text":"- Axial deformities over 10° on the study knee."}
• {"criterion_text":"- Systemic corticoid or immunosuppressive medication, or anticoagulant therapy, ongoing or recent, (used regularly during the last 3 months before the planned knee surgery). Intraarticular corticoid medication is not allowed within the same time period."}
• {"criterion_text":"- Active infection or any other condition limiting the healing (e.g., immunodeficiency, hepatitis, active tuberculosis, neoplasm, diabetes and other serious metabolic disorders, drug abuse, etc.)."}
• {"criterion_text":"- Concurrent or previous cancer."}
• {"criterion_text":"- Blood, plasma or platelet transfusion during previous 8 weeks."}
• {"criterion_text":"- Pregnant or lactating women."}
• {"criterion_text":"- BMI higher than 40."}
• {"criterion_text":"- Clinical instability of the knee joint."}

Primary endpoints

• {"endpoint_text":"- Lysholm knee function score, at 24 months post-operation (comparison of score changes between the study arms).","definition_or_measurement_approach":"Lysholm knee function score measured at 24 months post-operation; comparison of score changes between study arms."}
• {"endpoint_text":"- KOOS value, at 24 months post-operation (comparison of score changes between the study arms).","definition_or_measurement_approach":"KOOS (Knee injury and Osteoarthritis Outcome Score) measured at 24 months post-operation; comparison of score changes between study arms."}
• {"endpoint_text":"- Pain according to VAS, at 24 months post-operation (comparison of score changes between the study arms).","definition_or_measurement_approach":"Pain measured by Visual Analogue Scale (VAS) at 24 months post-operation; comparison of change between study arms."}
• {"endpoint_text":"- X-ray and MRI evaluation, at 24 months post-operation.","definition_or_measurement_approach":"Radiological assessment by X-ray and MRI at 24 months post-operation; comparison between study arms."}

Secondary endpoints

• {"endpoint_text":"- Lysholm knee function score, at 3, 6 and 12 months post-operation.","definition_or_measurement_approach":"Lysholm knee function score measured at 3, 6 and 12 months post-operation; comparison of score changes between study arms."}
• {"endpoint_text":"- KOOS value, at 3 , 6 and 12 months post-operation.","definition_or_measurement_approach":"KOOS measured at 3, 6 and 12 months post-operation; comparison of score changes between study arms."}
• {"endpoint_text":"- Pain according to VAS, at 6 weeks, 3, 6 and 12 months post-operation.","definition_or_measurement_approach":"Pain measured by VAS at 6 weeks, 3, 6 and 12 months post-operation; comparison between study arms."}
• {"endpoint_text":"- X-ray and MRI evaluation, at 12 months post-operation.","definition_or_measurement_approach":"Radiological assessment by X-ray and MRI at 12 months post-operation; comparison between study arms."}
• {"endpoint_text":"- Adverse event profiles at 6 weeks, 3, 6, 12 and 24 months post-operation (comparison between the study arms).","definition_or_measurement_approach":"Collection and comparison of adverse event profiles at specified timepoints between study arms."}

Czechia

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

15-11-2024

Processing Time Days

10

Number Of Sites

3

Number Of Participants

40

Primary sponsor

Full Name

Bioinova a.s.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Czechia