NTX-001 to Repair Peripheral Nerve Transection(s)

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

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

Study Overview

• Status: Temporarily not available
• Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
• Intervention / Treatment: Combination product: NTX-001

Detailed Description

For this expanded access program, there is a case-by-case internal review process conducted by Neuraptive after the respective investigator provides a prospective case narrative for enrollment consideration.

Allowed Sunderland Classifications are IV degree (Seddon's Class II) and V degree (Seddon's Class III). If the case is approved, the investigator can move forward.

Patients who are between twelve (12) and eighty (80) years of age and has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and require surgical treatment. All peripheral nerve repairs including gap repairs (autografts) will be considered for enrollment.

• Study Type: Expanded Access
• Expanded Access Type: Intermediate-size Population; Treatment IND/Protocol

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32806
      • Orlando Health Orthopedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 80 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

Description

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.

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Neuraptive Therapeutics Inc.

Study record dates

Study Registration Dates

• First Submitted: July 21, 2022
• First Submitted That Met QC Criteria: September 28, 2022
• First Posted (Actual): October 4, 2022

Study Record Updates

• Last Update Posted (Estimated): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Wounds and Injuries; Neuromuscular Diseases; Peripheral Nervous System Diseases; Trauma, Nervous System; Peripheral Nerve Injuries
• Other Study ID Numbers: EA-NTX-22-002