BioCart™II is a novel scaffold seeded with autologous chondrocytes to be used to repair cartilage lesions of the knee. This study is designed to compare the efficacy and safety of BioCart™II treatment compared to microfracture which is the classical method of treatment.
Full thickness cartilage lesions are typically incapable of self repair, are a source of pain and morbidity and lead to early onset osteoarthritis. A classical method of treatment has been microfracture where holes are drilled in the subchondral bone to allow influx of bone marrow cells which fill and repair the lesion. The resulting repair has been reported to be mixed fibrocartilage which is recognized to be less efficient and durable than hyaline cartilage, the physiological material making up the joint. In autologous chondrocyte implantation, a sample of cartilage is removed from a non-weight bearing region of the joint and the cells are grown and expanded in culture and then returned to the knee to repair the damaged cartilage. For implantation with BioCart™II, the chondrocytes are grown in the presence of proprietary growth factors which maintain the chondrocytes in optimal condition for subsequent repair. For implantation, the cells are seeded on a completely human three dimensional spongelike scaffold which holds the cells in the correct topology to allow for a rapid repair of the damaged joint with true physiological cartilage. BioCart™II is user friendly for the surgeon and patient alike giving it an advantage over other methods for autologous chondrocyte implantation that are in clinical use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
A cartilage biopsy will be harvested from patients during arthroscopy and used for chondrocyte isolation, culture and future implantation. Subjects will also have about 80 ml venous blood drawn for autologous cell culture medium. Two-four weeks following biopsy harvest, BioCart™II will be implanted into the cartilage defect after careful debridement via miniarthrotomy.
MF procedure will be carried out according to accepted practice. After careful debridement multiple perforations, or microfractures, are made in the subchondral bone using an awl. The released bone marrow forms a clot at the lesion site which is an enriched environment for new tissue formation. With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn. This will be used for chondrocyte culture and cryopreservation in case a later BioCart™II implantation is required after failure of the microfracture procedure.
Tucson Orthopaedic Institute
Tucson, Arizona, United States
Southeastern Orthopedic Center
Savannah, Georgia, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, United States
Mount Sinai Medical Center
New York, New York, United States
Improvement in the Lysholm joint function score of subjects in the BioCart™II study group compared with the MF study group
Time frame: 12 months with optional follow up to 5 years
Improvement in clinical function post implantation/surgery compared to baseline in the study group and compared with the control group, of the following:
Time frame: 12 months with optional follow up to 5 years
IKDC knee score
Time frame: 12 months with optional follow up to 5 years
KOOS questionnaire
Time frame: 12 months with optional follow up to 5 years
ICRS functional status
Time frame: 12 months with optional follow up to 5 years
VAS pain score
Time frame: 12 months with optional follow up to 5 years
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University Orthopedics Center
Altoona, Pennsylvania, United States
Sheba Medical Center Tel Hashomer
Ramat Gan, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Assaf Harofeh Medical Center
Ẕerifin, Israel