Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage (NCT01605201) | Clinical Trial Compass
CompletedPhase 1
Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage
Switzerland18 participantsStarted 2012-08-29
Plain-language summary
The purpose of this study is to investigate the safety and feasibility of implanting an engineered cartilage graft obtained by culturing expanded autologous nasal chondrocytes within a collagen type I/III membrane into the cartilage defect on the femoral condyle and/or trochlea of the knee after a traumatic injury.
Who can participate
Age range18 Years – 55 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Size of the defect on the femoral cartilage:one or two symptomatic lesion(s) grade III-IV from 2 cm2 to 8 cm2 at the femoral condyle and/or trochlea
* Other:
* Age: 18-55 years
* Written informed consent by the patient
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 n…