Tissue Engineered Nasal Cartilage for Regeneration of Articular Cartilage
Sponsored by University Hospital, Basel, Switzerland
About this trial
Last updated 8 years ago
Study ID
92/11
Status
Completed
Type
Interventional
Phase
Phase 1
Placebo
No
Accepting
18 to 55 Years
All Sexes
Trial Timing
Ended 8 years ago
What is this trial about?
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.
What are the participation requirements?
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 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