40
Participants
Start Date
May 31, 2008
Primary Completion Date
May 31, 2012
Study Completion Date
May 31, 2015
BioCart™II
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.
Microfracture
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 With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn.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.
University Orthopedics Center, Altoona
Sinai Hospital of Baltimore, Baltimore
Southeastern Orthopedic Center, Savannah
Sheba Medical Center Tel Hashomer, Ramat Gan
Tel Aviv Sourasky Medical Center, Tel Aviv
Assaf Harofeh Medical Center, Ẕerifin
Tucson Orthopaedic Institute, Tucson
Mount Sinai Medical Center, New York
Lead Sponsor
ProChon Biotech Ltd
INDUSTRY