Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial NervesNCT05565846
NTX-001 to Repair Peripheral Nerve Transection(s)
A study testing NTX-001 in people with Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves, run by Neuraptive Therapeutics Inc. at 2 sites in United States.
Trial summary
The proposed use of NTX-001 for transections of upper extremity and facial peripheral nerves, acutely or planned. Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
- What is being tested?
- NTX-001
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients whose nerve repair will occur greater than 48 hours after nerve transection.
- Patients requiring repair of the intracranial portion of any nerve.
- Patients requiring a nerve repair involving an allograft or conduit.
- Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
- 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.
- 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).
- The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
- Available
Orlando Health Orthopedic Institute
Orlando, Florida, 32806
Karan A Desai, MD, 321-843-5851, Karan.Desai@orlandohealth.com
David J Krol, CRC, 321-843-5687, David.Krol@orlandohealth.com
- Available
Harborview Medical Center
Seattle, Washington, 98104
Yusha (Katie) Liu, MD PhD, 206-744-4263, ykliu@uw.edu
Laura Hennessy, RN, 206-276-6235, hennessy@uw.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- NTX-001
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-001Combination product
One-time use surgical product of three solutions and a device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial NervesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Neuraptive Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05565846
- Sponsor's protocol ID
- EA-NTX-23-001
- Status last verified
- Jun 2026
- First submitted
- 21 Jul 2022
- Last updated
- 8 Jul 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Using NTX-001 to Repair Peripheral Nerve Transection(s)
- ClinicalTrials.gov ID
- NCT05565846
- Acronym / sponsor ID
- EA-NTX-23-001
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Neuraptive Therapeutics Inc.Industry (pharma, biotech, devices)
- First posted
- 4 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (7 listed)
- Patients whose nerve repair will occur greater than 48 hours after nerve transection.
- Patients requiring repair of the intracranial portion of any nerve.
- Patients requiring a nerve repair involving an allograft or conduit.
- Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-001One-time use surgical product of three solutions and a device | Combination product | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NTX-001 in people with Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves, run by Neuraptive Therapeutics Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seth Schulman, MD (617-416-4520, seth.schulman@neuraptive.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.