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

ProChon Biotech

Status and phase

Unknown

Phase 2

Conditions

Symptomatic Cartilage Defects of the Femoral Condyle

Treatments

Biological: BioCart™II

Procedure: Microfracture

Study type

Interventional

Funder types

Industry

Identifiers

NCT00729716

BioCart™II 005-06

Details and patient eligibility

About

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 description

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.

Enrollment

40 estimated patients

Sex

All

Ages

16 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
Associated damage to the underlying subchondral bone requiring an osteochondral graft
History of secondary arthropathies (i.e. sickle cell disease, Hemochromatosis, or autoimmune disease)
Receiving prescription pain medication other than NSAIDs or acetaminophen for conditions unrelated to the index knee conditions
BMI >40 kg/m2
Unable to undergo MRI
Any reasons making the patient a poor candidate in the eyes of the investigator