What side effects are associated with this type of intervention?

Common treatments for digital nerve injury that are similar to the NeuraGen 3D Nerve Guide Matrix include nerve grafts, nerve conduits, and other regenerative scaffolds. Known side effects of these treatments can include infection, scarring, pain at the donor or graft site, and incomplete or delayed nerve regeneration. In some cases, there may also be an immune response to the graft material, leading to inflammation or rejection. Additionally, patients may experience sensory disturbances or motor deficits depending on the extent of the injury and the success of the treatment.

What prior FDA approvals exist?

The FDA has approved several treatments for digital nerve injury that involve the use of nerve guides, conduits, or matrices to support nerve regeneration. These include products like the AxoGuard Nerve Connector and the Avance Nerve Graft. These devices provide a scaffold that facilitates the alignment and growth of regenerating nerve fibers, similar to the NeuraGen 3D Nerve Guide Matrix being studied. Such treatments aim to improve functional recovery by guiding the regrowth of nerves across the injury site.

What other types of research exist?

Promising alternatives to NeuraGen 3D Nerve Guide Matrix for digital nerve injury treatment include: 1) Human embryonic stem cell-derived oligodendrocyte progenitor cell transplants, which have shown potential in remyelination and functional recovery. 2) Polymer-encapsulated human stem cell-derived beta cells, which offer long-term glycemic control and could be adapted for nerve regeneration. 3) Advanced motorized intramedullary nails for limb lengthening and bone transport, which may be applicable in nerve repair contexts. These alternatives leverage cutting-edge stem cell and biomaterial technologies to support nerve regeneration.

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Nerve Guide Matrix

NeuraGen 3D for Digital Nerve Injury

N/A

Waitlist Available

Research Sponsored by Integra LifeSciences Corporation

Eligibility Criteria Checklist

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

Must have

Subject has one, single level, digital nerve injury that involves complete traumatic nerve section of the common or proper nerve of the palmar aspect of hand

Subject has adequate vascular perfusion of the target hand as assessed by the investigator

Must not have

Disorder known to affect the peripheral nervous system (PNS)

Gross contamination of the wound in which the nerve to be studied resides

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a device called NeuraGen 3D Nerve Guide Matrix, which helps repair damaged nerves. It is aimed at patients with peripheral nerve injuries and works by providing a supportive structure for nerve cells to grow back together.

Who is the study for?

This trial is for individuals who have recently (within 21 days) suffered a complete traumatic cut of specific nerves in the palm. They must be able to close the nerve gap without too much tension using the device, have good blood flow in their hand, and can keep their injured hand still after surgery. The other hand should be fully functional.

What is being tested?

The study is testing NeuraGen 3D Nerve Guide Matrix on people with digital nerve injuries. It's an initial look at how well it works and its safety over a year with ten participants across multiple centers, without comparing it to another treatment.

What are the potential side effects?

Since this summary doesn't provide specific side effects of NeuraGen 3D Nerve Guide Matrix, we can assume general risks may include infection, pain at the injury site, inflammation or allergic reactions related to implant materials.

Eligibility Criteria

Inclusion Criteria

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

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I have a single, completely cut nerve injury in my hand.

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My hand's blood flow is good, as checked by my doctor.

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My other hand is fully functional and healthy.

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I can keep my injured hand still after surgery.

Exclusion Criteria

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

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I have a condition that affects my peripheral nervous system.

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My wound with the nerve to be studied is severely infected.

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I have an infection near my nerve injury.

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My vital signs are stable.

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I have existing nerve damage or diagnosed nerve compression in my arms.

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I have had an injury or was born with a condition in my hand or arm that could affect nerve healing.

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The nerve needing repair in my body controls both movement and sensation.

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

The primary objective of this study is to evaluate return to sensory recovery with the NeuraGen 3D Nerve Guide Matrix in a small group of subjects with primary nerve injury of the hand.(s2PD) at each post-operative timepoint of the study.

Secondary study objectives

Continuous Visual Analog Scale for Pain at each post-operative timepoint of the study

Disabilities of the Arm, Shoulder and Hand (DASH) Score at each post-operative timepoint of the study

Grip Strength Test at each post-operative timepoint of the study

+4 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: NeuraGen 3D Nerve Guide MatrixExperimental Treatment1 Intervention

Integra NeuraGen 3D Nerve Guide Matrix is a resorbable implant for the repair of peripheral nerve gaps.

0 / 11Eligibility 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

Common treatments for digital nerve injury include surgical repair, nerve grafting, and the use of nerve guide conduits like the NeuraGen 3D Nerve Guide Matrix. Surgical repair involves direct suturing of the nerve ends, while nerve grafting uses a segment of another nerve to bridge the gap. Nerve guide conduits provide a scaffold that supports and directs the growth of regenerating nerve fibers across the injury site. These treatments are crucial as they aim to restore nerve continuity, promote axonal growth, and ultimately recover sensory and motor functions, which are vital for the patient's hand functionality and quality of life.