A Study of MACI in Patients Aged 17 to 65 Years With Symptomatic Chondral or Osteochondral Defects of the Ankle

Exclusion Criteria

• •1. Lesions with an underlying bony defect depth of \> 5 mm.
• •2. Any surgery on the target joint within 24 weeks prior to Visit 1 (not including diagnostic ankle arthroscopy).
• •3. Previous investigational drug, biologic or device use within 12 weeks prior to Visit.
• •4. Avascular necrosis of the target ankle.
• •5. Symptomatic musculoskeletal conditions in the lower limbs that could impede measurement of efficacy for the target ankle joint.
• •6. Subjects with "kissing lesions" (bipolar lesions, involving both the tibia and talus), or with bilateral lesions in both ankles.
• •7. Subjects with lesions that require an osteotomy procedure to allow for MACI implantation as determined at the time of ankle arthroscopy (Visit 2).
• •8. Concomitant systemic inflammatory diseases or other conditions that affect the joints (e.g., rheumatoid arthritis, metabolic bone disease, psoriasis, symptomatic chondrocalcinosis).
• •9. History of advanced or severe osteoarthritis of the ankle as determined by prior surgical history confirming no joint space (i.e., "bone on bone") or radiographic evidence of Modified Kellgren-Lawrence Grade 4 arthritis (i.e., osteophytes on lateral and medial malleoli and at the tibiotalar joint margins, narrowing of the joint space width \> 50%, and tibiotalar sclerosis), Van Dijk Grade III (i.e., total or subtotal destruction of the joint space) or the equivalent.
• •10. Known history of septic arthritis in the target ankle joint within 1 year prior to Visit 1.
• •11. Current malignancy or treatment for malignancy within the past 5 years prior to Visit 1, excluding non-melanoma skin cancer.
• •12. Known history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin.
• •13. Females who are pregnant or lactating.
• •14. Patients who, in the opinion of the Investigator, have significant medical or psychosocial problems that warrant exclusion. Examples of significant problems included but are not limited to:
• •1. Any condition that has potential for negatively impacting intra- or postoperative course.
• •2. Conditions that limit compliance with rehabilitation program.
• •3. Any condition that has potential for significantly limiting patient's ability to assess postoperative ankle function.
• •4. Any condition, psychiatric or otherwise, that would preclude informed consent/assent, consistent follow-up, or compliance with any aspect of the trial.
• •5. Patient is currently abusing drugs or alcohol or, in the opinion of the Investigator, at high risk for poor compliance.
• •6. Any result from screening blood work (including complete blood count, Prothrombin Time (PT)/Partial Thromboplastin Time (PTT)/INR, liver function, and creatinine) that exceeds 1.5x the upper limit of normal or is below 0.5x the lower limit of normal.