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Sponsored by: |
ProChon Biotech Ltd |
Information provided by: | ProChon Biotech Ltd |
ClinicalTrials.gov Identifier: | NCT00729716 |
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.
Condition | Intervention | Phase |
Symptomatic Cartilage Defects of the Femoral Condyle |
Procedure: BioCart™II Procedure: Microfracture |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study to Investigate the Efficacy and Safety of BioCart™II in the Treatment of Chronic Symptomatic Cartilage Defects of the Femoral Condyle in Comparison With Microfracture |
Estimated Enrollment: | 40 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | May 2014 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
A: Experimental
BioCart™II treatment
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Procedure: 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.
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B: Active Comparator
Microfracture procedure
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Procedure: 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 With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn.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.
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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.
Ages Eligible for Study: | 16 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Zipi Roth-Ben Arie, PhD | +972-8-9303021 | zipi.benarie@prochon.co.il |
United States, New York | |||||
Mount Sinai Medical Center | Recruiting | ||||
New York, New York, United States, 10029-6754 | |||||
Principal Investigator: James N Gladstone, MD | |||||
Israel | |||||
Assaf Harofeh Medical Center | Recruiting | ||||
Zerifin, Israel, 70300 | |||||
Principal Investigator: Gabriel Agar, MD | |||||
Sheba Medical Center Tel Hashomer | Recruiting | ||||
Ramat Gan, Israel, 52662 | |||||
Principal Investigator: Gideon Burshtein, MD |
ProChon Biotech Ltd |
Study Director: | Avner Yayon, PhD MD | ProChon Biotech Ltd |
Responsible Party: | ProChon Biotech Ltd ( Clinical Director ) |
Study ID Numbers: | BioCart™II 005-06 |
First Received: | August 4, 2008 |
Last Updated: | August 6, 2008 |
ClinicalTrials.gov Identifier: | NCT00729716 |
Health Authority: | United States: Food and Drug Administration; Israel: Ministry of Health |
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