Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage

Exclusion Criteria

• •Defect:
• •* Lesions smaller than 2cm2 or greater than 8cm2
• •* Total area of all lesions bigger than 8cm2
• •* Lesions other than on the femoral condyle and/or trochlea
• •* Any evidence of the following diseases in the target joint: septic arthritis; inflammatory joint disease; gout; recurrent episodes of pseudogout; Paget disease of bone; ochronosis; acromegaly; hemochromatosis;Wilson disease; primary osteochondromatosis; heritable disorders; collagen gene mutations
• •* Presence of a clinically relevant cartilage lesion on the patella (second lesion)
• •* Patellofemoral cartilage lesion
• •* Presence of relevant complex knee injuries affecting bone and/or ligaments
• •* Osteochondritis dissecans: recent (within 1 year before baseline); depth of lesion \>0.5 cm; subchondral sclerosis
• •* Advanced osteoarthritis (as defined by Radiographic Atlas of Osteoarthritis, grade 2-3)
• •* Varus or valgus malalignment exceeding 5° (kissing lesions out)
• •Medical history:
• •* gravidity (Pregnancy)
• •* breast feeding
• •* presence of multiple severe allergies (including porcine collagen, streptomycin and penicillin)
• •* Osteoarthritis
• •* Current diagnosis of osteomyelitis
• •* Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
• •* A blood result showing liver enzymes (serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase, alkaline phosphatase) of more than 2 times the upper limit of normal or any other result that in the clinical investigator's mind is clinically important
• •* C-reactive protein level greater than 10 mg/L
• •* Uncontrolled diabetes
• •* Renal insufficiency
• •* Previous pacemaker implantation
• •* Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
• •* Mosaicplasty (osteochondral autograft transfer system)
• •* Microfracture performed less than 1 year before baseline
• •* Received hyaluronic acid intra-articular injections into the afflicted knee within the last 6 months of baseline Meniscal transplant (previous/present)
• •* Meniscal suture with meniscal arrows ipsilaterally (present or previous if not resorbed)
• •* Taking specific osteoarthritis drugs, such as chondroitin sulfate, diacerein, n-glucosamine, piascledine, and capsaicin, within 2 weeks of the baseline visit
• •* Corticosteroid therapy by systemic or intra-articular route within the last month of baseline or intramuscular or oral corticosteroids within the last 2 weeks of baseline
• •* Chronic use of anticoagulants
• •* Patients with human immunodeficiency virus, hepatitis, or syphilis
• •* Malignancy
• •* Alcohol and drug (medication) abuse
• •* Poor general health condition as judged by investigator
• •* Body mass index \>35 kg/m2
• •* Medication:chronic treatment with steroids or growth factors (immunomodulatory drugs)
• •Other:
• •* Participation in concurrent clinical trials
• •* Participation in a previous clinical trial within 1 year