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

Status unconfirmed · Phase 2

Conditions studied: Symptomatic Cartilage Defects of the Femoral Condyle

In brief

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.

Key facts

Study ID

NCT00729716

Run by

ProChon Biotech Ltd

People needed

40

Starts

2008-05-01

Expected to finish

2015-05-01

Last updated by the study team

2012-04-17

Who can join

Age: 16 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 16 to 60 years
• Femoral condyle lesion (medial, lateral or trochlea)
• Single contained lesion
• Symptomatic (moderate to severe pain on VAS)
• Caused by trauma or OCD
• Depth of lesion up to 6 mm
• Size of lesion 1.5-7.5 cm2
• No general bone or cartilage pathology
• No limb mal-alignment (long leg standing X-ray)
• Mechanically stable knee
• Accompanying pathology menisectomy up to 50%
• Willing and able to comply with protocol and undergo vigorous rehabilitation
• Signed informed consent

You may not qualify if…

• Multiple cartilage lesions of the knee, other location than femoral condyle (medial, lateral or trochlear), deeper than 6 mm, smaller than 1.5cm2 or greater than 7.5cm2, mild symptoms, caused by reason other than trauma or OCD, unstable knee, accompanying pathology other than 50% menisectomy.
• Hyaluronic acid knee injections in the past 3 months,
• History of chronic bone or cartilage disorder, bilateral knee pain and/or cartilage lesion
• History of any neoplastic disease, or chemotherapy treatment
• Chronic steroid intake, chronic pain medication use for conditions other than the involved knee, use of blood thinners (during the past 10 days prior to enrollment)
• History of allergy or atopic disease, sensitivity to blood products
• Evidence of any significant systemic disease, known coagulopathies or acute injury that might compromise the patient's welfare
• Pregnant or lactating women
• Substance or alcohol abuse
• Microfracture to the affected knee within the previous 2 years
• Participation in concurrent trials
• Participation in previous trials within 3 months
• Malignancy
• Taking specific drugs for osteoarthritis, such as chondroitin sulfate, diacerein, n-glucosamine, piaseledine, or capsaicin within 2 weeks of the baseline visit
• Chronic use of anticoagulants
• Uncontrolled diabetes
• Active joint infection
• Other unstable cardiac and pulmonary disorder
• Liver enzymes (SGOT, SGPT, alkaline phosphatase) of more then two times the upper limit of normal or any other results that in the clinical investigator's mind is important clinically
• Clinical and/or radiographic disease in the indexed affected joint that includes:
• Osteoarthritis or avascular necrosis
• Rheumatoid arthritis or a history of septic or reactive arthritis
• Gout or a history of gout or pseudogout in the affected knee
• Osteochondritis dissecans of the knee with significant bone loss
• Bipolar articular cartilage involvement (or kissing lesions) of the ipsilateral compartment (i.e >than ICRS grade 2 on the opposing articular surface)

Where it is running

• 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
• 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

Full record on ClinicalTrials.gov

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