Evaluating the Safety and Efficacy of Polyethylene Glycol (PEG) Mediated Fusion (PEG Fusion)

NCT04789044 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: W81XWH2010825
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 7

Brief Summary

The overall objective of this study is to determine the safety of PEG fusion when used with primary repair or reconstruction in patients with an acute upper extremity peripheral nerve injury. PEG is safe and effective for extending the half-life of circulating pharmaceutical products, when used in conjunction with a topical hemostatic agent in surgical wounds, and when used as a colon cleanser for endoscopic surgical procedures. However, PEG fusion has not been rigorously tested as a safe reagent to promote nerve regeneration in humans. Therefore, the goal of this Phase 2a clinical trial is to establish safety data and to examine the effect of PEG fusion on clinical outcomes including recovery of sensory and motor function. Results will be externally validated using data collected in the DoD funded prospective NERVE study and will provide preliminary evidence to power a larger phase II efficacy trial.

Conditions

Peripheral Nerve Injuries

Outcome Measures

Primary Outcomes (1)

• Complications or problems that occur with in the first 30 days.

  Complications or problems include surgical site infections, wound dehiscence/breakdown, exposure of nerves and/or their repairs and reconstructions, breakdown of nerve repair or reconstruction, seroma/hematoma requiring an additional procedure to treat, and any other local wound complications related to the zone of nerve injury that require an additional surgical procedure

  Up to 2 years

Study Arms (2)

PEG mediated reconstruction

EXPERIMENTAL

NTX-001 will be administered topically via isolation chamber medical device. Dose Unit: 2.5 mL NTX-001 is a single use surgical product intended for use as adjunct treatment in the repair of severed peripheral nerves in patients requiring standard suture neurorrhaphy.

Drug: NTX-001

Conventional nerve reconstruction

NO INTERVENTION

Conventional nerve reconstruction

Interventions

NTX-001 DRUG

• PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.

PEG mediated reconstruction

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ages 18-80
• Sustained a complete peripheral nerve injury resulting from upper extremity trauma presenting within 48 hours of injury
• Involves injury or dysfunction to motor and/or sensory function of the axillary, radial, median, ulnar, or musculocutaneous nerve with injury localized between the proximal humerus and the distal flexion crease of the wrist
• Involves a "mixed" nerve segment (i.e., involves a location of any of the above specified nerves that can be expected to have both sensory and motor axons present).

You may not qualify if:

• Patients beginning surgery within hours after injury.
• Injury to the brachial plexus nerves
• Injury to the nerves distal to the distal flexion crease of the wrist
• Injury that involves a distal extension of the parent nerve that is considered sensory only (superficial radial nerve, lateral antebrachial cutaneous nerve, etc.) or the posterior interosseus or anterior interosseus nerve distal to the midpoint of the forearm (i.e., distal to what can be considered the main motor branches of the PIN and AIN).
• Previous peripheral nerve injury resulting from trauma, stroke, muscular, neurologic, or neuromuscular disorder
• Documented psychiatric disorder that is expected to result in high probability of self-harm or interfere with study follow-up.
• Severe problems with maintaining follow up (e.g., patients who are prisoners or homeless at time of injury or who are intellectually challenged without adequate family support).
• Not expected to survive the next 30 days due to their injuries/health condition.
• The subject has a known allergy to polyethylene glycol (PEG).
• If any of the assessments cannot be done on the contralateral side (CL) or the MRCC sensory 2PD value is \> 10 mm on the CL side during baseline period, the subject is a screen failure.
• The subject is pregnant and/or is breastfeeding.
• The subject has a significant medical comorbidity precluding immediate repair.
• The subject is not able to strictly adhere to the rules of the current clinical protocol.

Sponsors & Collaborators

• Major Extremity Trauma Research Consortium: lead
• United States Department of Defense: collaborator

Study Sites (7)

University of Maryland Medical Center Shock Trauma Center

Baltimore, Maryland, 21201, United States

RECRUITING

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21213, United States

RECRUITING

Cooper Health

Camden, New Jersey, 08103, United States

RECRUITING

OrthoCarolina

Charlotte, North Carolina, 28207, United States

RECRUITING

Wellspan Health

York, Pennsylvania, 17403, United States

RECRUITING

San Antonio Military Medical Center (SAMMC)

San Antonio, Texas, 78234, United States

RECRUITING

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23219, United States

RECRUITING

MeSH Terms

Conditions

Peripheral Nerve Injuries

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Ala Elhelali, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Wysocki, MA

CONTACT

410-955-0396; ewysock2@jhu.edu

Ala Elhelali, PhD

CONTACT

443-220-2537; aelhela1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study will enroll 40 patients receiving autograft reconstruction within 24 hours of injury. Patients within each group will be randomized to either PEG mediated reconstruction (n=20); or conventional nerve reconstruction (n=20).

Study Record Dates

• First Submitted: February 22, 2021
• First Posted: March 9, 2021
• Study Start: June 1, 2023
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)