What side effects are associated with this type of intervention?

Common treatments for peripheral nerve injury include surgical repair, nerve grafting, and the use of neurotrophic factors. Surgical repair and nerve grafting can lead to complications such as infection, scarring, and incomplete recovery of nerve function. Neurotrophic factors, which promote nerve growth, may cause side effects like pain at the injection site and systemic effects if absorbed into the bloodstream. For treatments similar to PEG-assisted axonal fusion, potential side effects could include local inflammation, allergic reactions to the polymer, and unintended fusion of non-target tissues. Overall, while these treatments aim to improve nerve repair, they carry risks that should be discussed with a healthcare provider.

What prior FDA approvals exist?

There is no specific mention of FDA-approved treatments for peripheral nerve injury similar to the Polyethylene Glycol (PEG) assisted axonal fusion technique in the provided context. Current strategies for peripheral nerve repair are limited, often involving surgical techniques that can take months for regenerating axons to reach target tissues. The PEG-assisted axonal fusion technique is being studied to expedite nerve repair by promoting immediate fusion of severed axons, potentially offering a more rapid restoration of function compared to existing methods.

What other types of research exist?

Promising novel alternatives to PEG-assisted axonal fusion for peripheral nerve injury include: 1) Stem cell therapies, particularly mesenchymal stem cells, which have shown potential in promoting nerve regeneration and functional recovery. 2) Growth factor delivery methods, such as the use of nerve growth factor (NGF) or brain-derived neurotrophic factor (BDNF), which can enhance nerve repair and regeneration. 3) Advanced biomaterials and scaffolds that provide structural support and promote cellular growth and differentiation. These alternatives are currently under investigation and may offer new avenues for treatment in the near future.

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Hydrophilic Polymer

PEG Fusion Technique for Peripheral Nerve Injury

Q: What is the mechanism of action of this treatment?

Polyethylene Glycol (PEG) Assisted Axonal Fusion works by promoting the immediate fusion of severed axonal membranes, thereby restoring axonal continuity and function within minutes. This rapid restoration is crucial for Peripheral Nerve Injury patients as it prevents Wallerian degeneration, maintains neuromuscular functions, and accelerates the return of voluntary behaviors. By quickly reestablishing nerve signaling, PEG therapy significantly improves early functional outcomes and reduces the long-term deficits typically associated with nerve injuries.

Phase 1

Recruiting

Led By Wesley Thayer, MD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Candidates for immediate operative repair (Arm 1)

Repair within 48 hours of injury that require nerve grafting

Must not have

Staged repair planned

Patients diagnosed with a neuromuscular disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment using PEG to help repair completely severed nerves in humans. PEG helps the nerve cells reconnect quickly, speeding up healing and improving recovery. PEG has been used in various animal models to improve outcomes in nerve repair by enabling immediate reconnection of injured nerve cells.

Who is the study for?

This trial is for individuals with a specific type of severe nerve injury in the upper extremity, known as Sunderland Class 5. They must be candidates for immediate surgery, with injuries no older than 72 hours and ready to commit to a year-long treatment and evaluation schedule. Excluded are those with contaminated wounds, inadequate tissue coverage, diabetes, neuromuscular diseases, or undergoing treatments affecting neural growth.

What is being tested?

The study tests polyethylene glycol (PEG) assisted axonal fusion technique for repairing peripheral nerve injuries. It aims to see if this method can rapidly restore function after an injury by immediately fusing severed nerves together during surgery.

What are the potential side effects?

While the side effects of PEG-assisted axonal fusion aren't detailed here, similar procedures may cause localized pain at the site of repair, possible inflammation or infection risk around the treated area and allergic reactions to materials used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a candidate for immediate surgery.

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I had surgery to repair a nerve within 2 days of being injured.

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I have nerve injuries with major blood vessel or bone damage.

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I have a severe nerve injury in my hand or arm from a cut.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My surgery is planned to be done in stages.

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I have been diagnosed with a neuromuscular disease.

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My wound lacks enough skin to cover it properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

return of nerve function as measured by (Medical Research Council Classificatoin (MRCC)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups

Experimental Treatment

Active Control

Group I: epineural repair with autografting within 48 hours, using PEGExperimental Treatment1 Intervention

epineural repair with auto grafting within 48 hours

Group II: epineural repair >24 but <72 hours using PEGExperimental Treatment1 Intervention

epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \>24 hours but \< 72 hours after injury); PEG is used during the surgical procedure

Group III: epineural repair <24 hours using PEGExperimental Treatment1 Intervention

epineural repair following treatment with standard epineural repair using PEG in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \<24 hours after injury); PEG is used during the surgical procedure

Group IV: standard epineural repair <24 hoursActive Control1 Intervention

epineural repair following treatment with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term acute injuries (repaired \<24 hours after injury); no medication used

Group V: epineural repair with autografting within 48 hoursActive Control1 Intervention

epineural repair with auto grafting within 48 hours; no medication used

Group VI: standard epineural repair >24 - 72 hoursActive Control1 Intervention

epineural repair following irrigation with standard epineural repair alone in sensory nerve injuries in the upper extremity in short-term chronic injuries (\>24-\<72 hours after injury); no medication used

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Polyethylene glycol (PEG)

2016

Completed Phase 4

~1520

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Polyethylene Glycol (PEG) Assisted Axonal Fusion works by promoting the immediate fusion of severed axonal membranes, thereby restoring axonal continuity and function within minutes. This rapid restoration is crucial for Peripheral Nerve Injury patients as it prevents Wallerian degeneration, maintains neuromuscular functions, and accelerates the return of voluntary behaviors. By quickly reestablishing nerve signaling, PEG therapy significantly improves early functional outcomes and reduces the long-term deficits typically associated with nerve injuries.

Immediate Enhancement of Nerve Function Using a Novel Axonal Fusion Device After Neurotmesis.Polyethylene glycol treated allografts not tissue matched nor immunosuppressed rapidly repair sciatic nerve gaps, maintain neuromuscular functions, and restore voluntary behaviors in female rats.Hydrophilic polymers enhance early functional outcomes after nerve autografting.