NG004 in Incomplete Spinal Cord Injury Patients

Who can take part

• Acute incomplete cervical SCI (Neurological level of injury C1 ≤ lesion ≤ C8) with confirmed classification of American Spinal Injury Association (ASIA) impairment scale (AIS) B, C and D at Screening
• 4-28 days post-injury and no earlier than 4 days after spinal surgery
• No required mechanical ventilation or patients that do not completely depend on mechanical ventilation
• Hemodynamically and clinical stable patient according to the acute SCI condition at baseline

Who cannot take part

• Patients with uncontrolled bleeding diathesis and/or who require concomitant therapeutic anticoagulation and not related to SCI
• Drug dependence any time within the last 6 months before Screening
• Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations
• Other significant pre-existing or current severe systemic disease
• History of or an episode of multiple sclerosis or Guillain-Barre syndrome
• History of recent meningitis or meningoencephalitis
• History of refractory epilepsy
• Presence of any unstable medical or psychiatric condition
• History of a life-threatening allergic or immune-mediated reaction
• Presence of infection around the location where the spinal needle insertions are planned for applying the intrathecal injections
• 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
• Pregnant or nursing women
• Patients who are unconscious