Phase 2 Clinical Trial of CartiLife® in the United States

Exclusion Criteria

• •Individuals who meet any of the following will be excluded from participation in this study:
• •1. Subject who has inflammatory articular diseases such as rheumatoid arthritis or gout or pseudogout
• •2. Subject who has radiographic evidence of grade 4 osteoarthritis based on the Kellgren and Lawrence criteria
• •3. Subject who has received an intra-articular treatment within the last 3 months
• •4. Subject who has had a surgical procedure on the knees within the last 6 weeks (Subjects can be considered enrollment per the investigator's discretion)
• •5. Subject who has a condition in another lower extremity joint that interferes with the function of the index knee
• •6. Subject who would receive a concomitant surgical procedure on the knees at the time of the study treatment
• •7. Subject whose articular cartilage defect is asymptomatic
• •8. Subject who has any clinically significant disease, which is judged by the investigator to affect this clinical trial, including but not limited to diabetes not adequately controlled, bleeding diathesis or hematologic disease, endocrinopathies, cardiovascular disease, renal disease (severe renal impairment), autoimmune disease, inflammatory arthritis, and current infectious disease
• •9. Subject with other diseases including tumors except for cartilaginous defects of joints
• •10. Subject who has a history of hypersensitivity to gentamicin, other aminoglycosides, or products of porcine or bovine origin
• •11. Subject who participates in concurrent trials or in previous trial within 30 days of signing informed consent
• •12. Subject who has any radiation therapy or chemotherapy within 2 years prior to screening
• •13. Subject who is currently pregnant or nursing
• •14. Subject who has any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.
• •15. Subject with known HIV infection, active hepatitis C and/or hepatitis B infection
• •16. Subject who has ligament instability \> Grade 1
• •17. Subject who is an active drug/alcohol abuser or has a history of alcohol or drug abuse during the last two years.
• •18. Subject who has significant lab abnormalities for the following parameters (If the value is within 10% of the listed laboratory exclusion criterion value and the value is considered not to be clinically significant by the investigator, the subject can be considered for enrollment):
• •* Serum ALT and AST \> 3 x upper limit of normal
• •* Serum creatinine \> 1.5 x upper limit of normal
• •* PT/INR out of normal range
• •* Hemoglobin \< 10 g/dL for female subject and hemoglobin \< 11 g/dL for male subject
• •* Platelets out of normal range
• •* Hemoglobin A1c levels \> 9%