An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)

EA-NTX-22-002

The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned.

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Inclusion: 1. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment. Exclusion: 1. Patients whose nerve repair will occur greater than 48 hours after nerve transection. 2. Patients requiring repair of the intracranial portion of any nerve. 3. Patients requiring a nerve repair involving an allograft or conduit. 4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy). 5. Patients who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow-up due to significant muscle atrophy or other morbidity. 6. The patient has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system). 7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.

{'studyType': 'EXPANDED_ACCESS', 'expandedAccessTypes': {'intermediate': True, 'treatment': True}}

2024-02-07