Comparison of BioCart™II With Microfracture for Treatment of Cartilage Defects of the Femoral Condyle

PHASE2UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

May 31, 2012

Study Completion Date

May 31, 2015

Conditions
Symptomatic Cartilage Defects of the Femoral Condyle
Interventions
BIOLOGICAL

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.

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 With the subject's consent a cartilage biopsy will be taken (at least 150 mg) and about 80 ml venous blood withdrawn.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.

Trial Locations (8)

16602

University Orthopedics Center, Altoona

21215

Sinai Hospital of Baltimore, Baltimore

31405

Southeastern Orthopedic Center, Savannah

52662

Sheba Medical Center Tel Hashomer, Ramat Gan

64239

Tel Aviv Sourasky Medical Center, Tel Aviv

70300

Assaf Harofeh Medical Center, Ẕerifin

85712

Tucson Orthopaedic Institute, Tucson

10029-6754

Mount Sinai Medical Center, New York

Sponsors
All Listed Sponsors
lead

ProChon Biotech Ltd

INDUSTRY