AP-011 Study to Evaluate the Safety of a Single Intra-articular Injection of Ampion™ for Arthritis of the Basal Thumb Joint

Exclusion Criteria

• •1. As a result of medical review and screening investigation, the Principal Investigator considers the subject unfit for the study.
• •2. Previous Ampion™ injection.
• •3. A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion).
• •4. A history of allergic reactions to excipients in 5% human albumin (N-acetyltryptophan, sodium caprylate).
• •5. Women who are currently pregnant or who could become pregnant.
• •6. Inflammatory or crystal arthropathies, acute fractures, history of aseptic necrosis, as assessed locally by the Principal Investigator.
• •7. Any other disease or condition interfering with the free use and evaluation of the index thumb for the duration of the trial (e.g., congenital defects, stricture).
• •8. Major injury to the index thumb within the 12 months prior to screening.
• •9. Any pharmacological or non-pharmacological treatment targeting OA started or changed during the 4 weeks prior to treatment or likely to be changed during the duration of the study.
• •10. Use of the following medications are exclusionary:
• •* IA injected pain medications in the study thumb during the study;
• •* Analgesics containing opioids;
• •* NSAIDs (including but not limited to ibuprofen, aspirin, naproxen, diclofenac) acetaminophen is available as a rescue medication during the study from the provided supply;
• •* Topical prescription treatment on osteoarthritis index thumb during the study;
• •* Significant anticoagulant therapy (e.g., Heparin or Lovenox) during the study (treatment such as Aspirin in the cardio-protective dose (81mg) and Plavix are allowed);
• •* Systemic treatments that may interfere with safety or efficacy assessments during the study;
• •* Immunosuppressants;
• •* Use of corticosteroids \> 10 mg prednisolone equivalent per day (if ≤ 10 mg prednisolone, the dose must be stable, defined as chronic use of the same dose for at least 1 month).
• •11. Any human albumin treatment in the 3 months before randomization.