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Table 2 Exclusion criteria for patients in the open-label study of APS on patients with knee OA

From: White blood cell concentration correlates with increased concentrations of IL-1ra and improvement in WOMAC pain scores in an open-label safety study of autologous protein solution

Exclusion Criteria
Disease Related Criteria
On day 1 (pre-injection), presence of active infection or abnormal effusion in the knee as noted by a physical examination (e.g., erythema, redness, heat, swelling)
Diagnosed with rheumatoid arthritis (RA), Reiter’s syndrome, psoriatic arthritis, ankylosing spondylitis, chondromalacia, arthritis secondary to other inflammatory diseases (e.g., inflammatory bowel disease [IBD], sarcoidosis, or amyloidosis)
Arthritis of metabolic origin
Ipsilateral hip OA
Untreated traumatic injury of knee
Limited daily activity for reasons other than OA
Presence of surgical hardware or other foreign body in the knee
Prior or concomitant OA treatment-related criteria
Arthroscopy or open surgery in knee within 12 months prior to screening
Intra-articular steroid injections in any joint within 3 months prior to screening
Intra-articular HA in any joint within 6 months prior to screening
Other intra-articular therapy in any joint within 3 months prior to screening
Taking systemic steroids within 2 weeks prior to screening
Planned/anticipated surgery of the knee during the study period
Patient-related criteria:
Any clinically significant results at screening (values or findings outside of normal ranges that were deemed clinically significant by the investigator)
Active or history of malignancy other than non-melanoma skin cancer
Any serious, non-malignant, significant, acute, or chronic medical condition (e.g., diabetes, cardiopathy) or active psychiatric illness that, in the investigator’s opinion, could have compromised patient safety, limited the patient’s ability to complete the study, and/or compromised the objectives of the study
Skin breakdown at the knee where the injection was planned to take place
Pregnant or nursing mothers, or women likely to conceive a child and unwilling to use a reliable form of birth control for the duration of the study
History of drug or alcohol dependence, and/or positive screening results from urine drug and alcohol tests
Used any investigational drug or device within 30 days prior to screening, or 5 half-lives, whichever is longer
Used any investigational biologic within 60 days prior to screening