NG004 in Spinal Cord Injury Patients

Exclusion Criteria

• •Trauma caused by ballistic or other injury that directly penetrates the spinal cord including gunshot and knife wounds
• •Multiple levels of clinically relevant spinal cord lesions
• •Major brachial or lumbar plexus damage/trauma
• •Significant head trauma or other injury that was, in the opinion of the investigator, sufficient to interfere with the assessment of the spinal cord function
• •Other significant pre-existing or current severe systemic disease such as lung, liver (exception: history of uncomplicated Hepatitis A), gastrointestinal, cardiac, immunodeficiency (including anamnestic known HIV) or kidney disease; or active malignancy
• •History of or an acute episode of Multiple Sclerosis or Guillain-Barre syndrome History of recent (6 months) meningitis or meningoencephalitis
• •History of refractory epilepsy
• •History of or current autoimmune disease
• •Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
• •Presence of any unstable medical or psychiatric condition
• •Drug dependence any time during the 6 month's preceding trial entry
• •Pregnant or nursing women
• •History of a life-threatening allergic or immune mediated reaction
• •Patients with the presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
• •Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
• •Patients who are unconscious