Use of Allocetra-OTS in End Stage Knee Osteoarthritis - Assessment of Safety

Ki vehet részt

• Age 18 or older
• Diagnosed with end-stage knee osteoarthritis and are scheduled or offered surgery
• X-ray positive for knee osteoarthritis
• Pain and functional disability from osteoarthritis
• Acceptable blood workup results (CBC, electrolytes, kidney and liver function) from up to three months before treatment
• Mentally and physically able to fully comply with the study protocol
• Signed Informed Consent form

Ki nem vehet részt

• Previous surgery of total or partial knee replacement in the injected knee
• Concurrent participation in any other clinical study. Participation in an interventional investigational study within 30 days prior to enrollment
• Evidence of active local infection in the vicinity of the knee joint
• Patients with a major medical condition that would affect quality of life and influence the results of the study
• Acute infection requiring intravenous antibiotics at the time of screening
• Known neurological disease or rheumatic condition other than osteoarthritis
• Bleeding disorders
• Known cognitive disorder
• Patients unable to provide informed consent due to language barrier or mental status
• Patients unwilling to be followed for the duration of the study
• Other limb pain of unknown etiology
• Pain in the limb clinically assessed to arise from an origin which is not the affected knee joint
• Physician objection
• Positive pregnancy test