A Phase I/II Study of AGA111 for Lumbar Interbody Fusion in Patients With Degenerative Disc Disease

Exclusion Criteria

• •1. Prior surgical procedure at the involved or adjacent spinal levels.
• •2. Presence or prior history of inflammatory disease of the spine.
• •3. Presence or prior history of neoplastic disease of the spine.
• •4. BMI \<18.5 or BMI \>35.
• •5. Documented titanium allergy or intolerance.
• •6. Presence or prior history of malignancy (except for fully resected basal cell carcinoma of the skin).
• •7. Presence or history of an uncontrolled, unstable, clinically significant medical condition that, in the opinion of the investigator, could jeopardize or compromise the subject's safety or ability to participate in this study.
• •8. Active local or systemic infection.
• •9. Female subject who is pregnant or lactating.
• •10. Serological evidence of positive human immunodeficiency virus (HIV) antibody.
• •11. HBsAg positive or HBeAg positive, along with positive HBV DNA test.
• •12. Serological evidence of HCV antibody, along with HCV RNA \> lower limit of detection.
• •13. Known drug or alcohol abuser.