Cartilage defects of knee joints, osteochondral defects MedDRA version: 18.0 Level: LLT Classification code 10007713 Term: Cartilage tear in knee System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 18.0 Level: LLT Classification code 10007702 Term: Cartilage biopsy System Organ Class: 100000004848 MedDRA version: 18.0 Level: LLT Classification code 10003423 Term: Articular cartilage disorder System Organ Class: 100000004859 MedDRA version: 18.0 Level
Conditions
Interventions
Product Name: co.don chondrosphere
Pharmaceutical Form: Living tissue equivalent
Other descriptive name: Viable autologous human cartilage-forming chondrocytes
Concentration type: range
Concentration
Sponsors
co.don AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female patients, age: between 18 and 50 years 2. Defect: isolated ICRS grade III or IV single defect on medial or lateral femoral condyle, trochlea, tibia and retropatellar defect, also OCD (in case of OCD: Bone grafting up to the level of the original bone lamella must be performed if bone loss exceeds 3 mm in depth) 3. Defect size: = 4 to 10 cm2 after debridement to healthy cartilage up to 6 mm in depth. Assessment with MRI at Screening and per estimation during arthroscopy prior to randomization 4. Nearly intact surrounding chondral structure around the defect as well as corresponding joint area 5. Informed consent signed by patient 6. Patient understands strict rehabilitation protocol and follow-up programme and is willing to follow it. 7. In case of pain, patient agrees to use only paracetamol mono- (max 4 g/day) or combination preparation and oral and/or topic NSAIDs during the trial and to discontinue the use of oral and/or topic NSAIDs and/or paracetamol combination preparation 1 week before each visit whereas the use of paracetamol mono-preparation (max 4 g/day) is allowed. However, in the morning of the visit day, no pain medication is allowed. Other pain medications are allowed during surgical operation and may be taken for a period not exceeding 4 weeks after surgery Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 75 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Defects on both knees at the same time 2. Radiological signs of osteoarthritis 3. Any signs of knee instability 4. Valgus or varus malalignment (more than 5° over the mechanical axis) 5. Clinically relevant second cartilage lesion on the same knee 6. More than 50 % resection of a meniscus in the affected knee or incomplete meniscal rim 7. Rheumatoid arthritis, parainfectious or infectious arthritis, and condition after these diseases 8. Pregnancy and planned pregnancy (no MRI possible) 9. Obesity (Body Mass Index >30) 10. Uncontrolled diabetes mellitus 11. Serious illness 12. Poor general health as judged by physician 13. Participation in concurrent clinical trials or previous trials within 3 months of screening 14. Previous treatment with ACT in the affected knee 15. Microfracture performed less than 1 year before screening in the affected knee 16. Alcohol or drug (medication) abuse 17. Meniscal transplant in the affected knee 18. Meniscal suture (in the affected knee) three months prior to baseline 19. Mosaicplasty (Osteoarticular Transplant System, OATS) in the affected knee 20. Having received hyaluronic acid intra-articular injections in the affected knee within the last 3 months of baseline 21. Taking specific ostheoarthritis drugs such as chondroïtin sulfate, diacerein, n-glucosamine, piascledine, capsaicin within 2 weeks of baseline 22. Corticosteroid treatment by intra-articular route within the last month of baseline or systemic (all routes) corticosteroïds within the last 2 weeks of baseline 23. Chronic use of anticoagulants 24. Any concomitant painful or disabling disease of the spine, hips or lower limbs that would interfere with evaluation of the afflicted knee 25. Any clinically significant or symptomatic vascular or neurological disorder of the lower extremities 26. Any evidence of the following diseases in the affected knee: septic arthritis, inflammatory joint disease, recurrent episodes of pseudogout, Paget's disease of bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, primary osteochondromatosis, heritable disorders, collagen gene mutation 27. Current diagnosis of osteomyelitis, human immunodeficiency virus (HIV-1, -2) and/or hepatitis C (HCV) infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: General Objectives: Assessment of the short-term and long-term efficacy and safety of 3 different doses of the three-dimensional autologous chondrocyte transplantation product ACT3D-CS for the treatment of cartilage defects (= 4-10 cm2) of knee joints. The health economic outcomes are mainly intended to be assessed and evaluated as a basis for future negotiations with health insurances, health care providers and development of newly implemented procedural codes within the German DRG (Diagnosis Related Groups) system for ACT3D-CS. Health economic data within the phase II study will be collected and assessed, where different doses of ACT3D-CS will be applied. Primary Objectives: Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) from baseline (Day 0) to final assessment (FA) at 12 months after transplantation determined for each dosage group and between the dosage groups;Secondary Objective: see protocol;Primary end point(s): Change of overall KOOS (Knee Injury and Osteoarthritis Outcome Score) from baseline (Day 0’) to final assessment (FA) at 12 months after transplantation determined for each dosage group and between the dosage groups.;Timepoint(s) of evaluation of this end point: 2014 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change of overall KOOS from baseline (Day 0) to 24, 36, 48 and 60 months (follow-up, FU) after transplantation determined for each dosage group Change of overall KOOS from baseline (Day 0) to, 24, 36, 48 and 60 months (follow-up, FU) after transplantation compared between the dosage groups Change of overall KOOS from Day 0’ (day before transplantation) to 12, 24, 36, 48 and 60 months (follow-up, FU) after transplantation determined for each dosage group and compared between the dosage groups Change of the 5 subscores of the KOOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee related Quality of life (QoL)) from baseline (Day 0 = day before arthroscopy) to 12, 24, 36, 48 and 60 months (follow-up, FU) after transplantation determined for each dosage group and between the dosage groups Change of the 5 subscores of the KOOS (Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec), knee related Quality of life (QoL)) from Day 0’ (day before transplantation) to 12, 24, 36, 48 and 60 months (follow-up, FU) after transplantation determined for each dosage group and between the dosage groups MOCART (MRI Score) at 12,24, 36, 48 and 60 months after transplantation compared between the dosage groups Arthroscopy and biopsy at 12 months after transplantation, assessment of cartilage repair after ACT3D-CS to be compared for each dosage group and between the dosage groups ICRS Visual Histological Assessment Score at final assessment (FA, 12 months) determined for each dosage group and compared between the dosage groups Bern Score and additional histological assessment scores at final assessment (12 months) determined for each dosage group and compared between the dosage groups Change of ICRS/IKDC from baseline (Day 0) to 12, 24, 36, 48 and 60 months after transplantation determined for each dosage group and compared between the dosage groups Chang | — |
Countries
Germany
Contacts
Public Contactco.don AG
co.don AG
Outcome results
None listed