A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy

Inclusion Criteria:

• Age 18 to 60, inclusive
• In need of medial meniscectomy
• Normal axial alignment
• Stable knee- previous ligament reconstruction, if stable
• Removal of at least 50% of the affected portion of the medial meniscus
• Intact articular cartilage in posterior meniscal weight-bearing zone
• Willingness to follow normal post-operative rehabilitation
• Willingness to participate in follow-up for two years from the time of meniscectomy surgery
• Ability to understand and willingness to sign consent form

Exclusion Criteria:

• Pregnant or lactating
• ACL or other support structure damage confirmed at surgery
• Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area >15mm on weight-bearing aspect of femoral condyle or tibial plateau)
• Synvisc, steroid, or corticosteroid injections in preceding 3 months
• Diffuse synovitis at time of arthroscopy
• Inflammatory arthritis
• Oral steroid, methotrexate therapy
• Unable to follow post-operative exercise regimen or return for evaluations
• Active alcohol or substance abuse within 6 months of study entry
• Current and active tobacco product use
• Patient is positive for HIV
• Patient is positive for hepatitis (past history of Hepatitis A is allowed)
• Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
• Indwelling pacemaker
• Cerebral aneurysm clips
• Ear, eye and penile implants with avian components
• Electrical indwelling device such as bone stimulator
• Indwelling magnets as tissue expander for future implants
• Known allergy to avian, bovine or porcine protein