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NTX-001 to Repair Peripheral Nerve Transection(s)

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

Status
AVAILABLE
Phases
Unknown
Study type
Expanded Access
Source
ClinicalTrials.gov
Registry ID
NCT05565846
Enrollment
Unknown
Registered
2022-10-04
Start date
Unknown
Completion date
Unknown
Last updated
2026-07-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves

Brief summary

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

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.

Interventions

COMBINATION_PRODUCTNTX-001

One-time use surgical product of three solutions and a device

Sponsors

Neuraptive Therapeutics Inc.
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
ALL
Age
12 Years to 80 Years

Inclusion criteria

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.

Countries

United States

Contacts

CONTACTSeth Schulman, MD
seth.schulman@neuraptive.com617-416-4520
CONTACTAnna Dodds, BS
anna.dodds@neuraptive.com724-991-4431

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 9, 2026