BP CC 001 for Cartilage defect of the knee joint | Articular cartilage defect

Inclusion criteria

• {"criterion_text":"- Patients of any gender with an age of ≥ 18 years to ≤ 60 years\n- Symptomatic grade III/IV cartilage defect according to ICRS or osteochondral defect with a maximum depth of 3 mm\n- A cartilage defect requiring treatment with a defect size of 2 - 6 cm² on the femoral condyles or patella or trochlea\n- Affected and contralateral knee (if known): Kellgren-Lawrence (K/L) osteoarthritis severity < grade III\n- KOOS pain sub-score of ≤ 70 (out of max. 100) in the affected knee joint and > 80 (out of max. 100) in the contralateral knee joint measured without taking analgesics within the last 24 hours\n- BMI < 35 kg/m²\n- Written informed consent"}

Exclusion criteria

• {"criterion_text":"- Known varus or valgus malalignment of the affected leg of ≥ 5°\n- Previous fracture in the affected knee joint\n- Osteoporosis\n- Relevant concomitant diseases that increase the risk of surgery, e.g. heart failure, coronary heart disease, coagulation disorders, diabetes mellitus, liver cirrhosis, renal insufficiency, etc.\n- History of hypersensitivity to porcine collagens, human albumin, glucose or components of fibrin adhesives used in orthopaedics or surgery\n- Simultaneous participation in another interventional clinical trial (incl. within the last 4 weeks before inclusion)\n- Addictions or other illnesses that do not allow the person con-cerned to assess the nature and extent of the clinical trial and its possible consequences\n- Any state that excludes adherence with the trial protocol (e.g. lack of compliance)\n- Persons who are placed in an institution by court or official order\n- Persons dependent on the sponsor\n- Pregnant or breastfeeding women\n- Antero-posterior or medio-lateral instability\n- Women of childbearing potential, except women who meet one of the following criteria: a) post-menopausal (12 months natural amenorrhoea) b) postoperative (6 weeks after bilateral ovarectomy with or with-out hysterectomy, bilateral salpingectomy) c) negative pregnancy test (urine) and regular and correct use of a contraceptive method with an Pearl Index < 1% per year - Combined (oestrogen and progestogen-containing) hormonal contraception - Hormonal contraception containing progestogens (oral, injected, implanted) - IUD (hormonal IUD, copper IUD) d) sexual abstinance e) vasectomy of the partner\n- Meniscus loss of more than 20% in the affected compartment\n- Patella instability\n- Simultaneous participation in surgery on other joint structures (cruciate ligament replacement, meniscus suture, partial meniscus resection > 20%, osteotomy)\n- Simultaneous higher-grade (ICRS grade III/IV) cartilage damage on the corresponding joint surfaces to the treated cartilage damage\n- Intra-articular application of hyaluronic acid or glucocorticoids or thrombocyte concentrates within the last 6 months\n- Joint replacement in the contra-lateral knee or hip within the last 12 months\n- Rheumatoid arthritis or other inflammatory diseases such as autoimmune diseases, seronegative spondyloarthritis, gout, pseudogout"}

Primary endpoints

• {"endpoint_text":"- Proportion of patients with a serious adverse event within 24 months after surgery","definition_or_measurement_approach":"Proportion of patients experiencing a serious adverse event (SAE) within 24 months after surgery (timeframe: 24 months post-surgery)."}

Secondary endpoints

• {"endpoint_text":"- Regeneration of damaged cartilage measured by MOCART score (relative change in the value 12 months after surgery compared to the initial value before surgery)","definition_or_measurement_approach":"MOCART score; relative change at 12 months post-surgery compared to baseline."}
• {"endpoint_text":"- Relative change in knee joint pain 12 and 24 months after the surgery compared to the baseline value before the surgery measured using the KOOS Pain Subscore","definition_or_measurement_approach":"KOOS Pain Subscore; relative change at 12 and 24 months compared to baseline."}
• {"endpoint_text":"- Relative change in knee-related quality of life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-QoL subscore","definition_or_measurement_approach":"KOOS-QoL subscore; relative change at 12 and 24 months compared to baseline."}
• {"endpoint_text":"- Relative change in symptoms and stiffness 12 and 24 months after surgery compared to pre-surgery baseline as measured by KOOS symptom subscore","definition_or_measurement_approach":"KOOS Symptoms subscore; relative change at 12 and 24 months compared to baseline."}
• {"endpoint_text":"- Relative change in activities of daily life 12 and 24 months after surgery compared to baseline before surgery measured by KOOS-ADL subscore","definition_or_measurement_approach":"KOOS-ADL subscore; relative change at 12 and 24 months compared to baseline."}
• {"endpoint_text":"- Relative change in physical resilience during sporting activities 12 and 24 months after the surgery compared to the baseline value before the surgery measured by KOOS-Excercise /Rec-Subscore","definition_or_measurement_approach":"KOOS Sport/Rec subscore; relative change at 12 and 24 months compared to baseline."}
• {"endpoint_text":"- AE, AR, SAE, SAR, SUSAR: Description of all adverse events (AE, AR, SAE, SAR, SUSAR) within 24 months after surgery in terms of severity (assessed according to National Cancer Institute - Common Terminology Criteria for Adverse Events Version 5.0 (NCI-CTCAE V 5.0)), causality, outcome","definition_or_measurement_approach":"Adverse events (AE, AR, SAE, SAR, SUSAR) within 24 months post-surgery described by severity (NCI-CTCAE v5.0), causality and outcome."}

Germany

Earliest CTIS Part Ii Submission Date

04-02-2025

Latest Decision Or Authorization Date

12-08-2025

Processing Time Days

189

Number Of Sites

7

Number Of Participants

55

Primary sponsor

Full Name

BIONCaRT GmbH

Organisation Type

Pharmaceutical company

Country Of Registered Address

Germany

Third parties

• {"country":"","full_name":"Sächsische Aufbaubank - Förderbank","duties_or_roles":"Source of monetary support / funding","organisation_type":""}