Scaffold Biomaterial for Neuropathy

Overseen By Jane Sultze

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Current smoker, Diabetes, Systemic immune disorders, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to test the safety of a new nerve repair method for patients requiring a sural nerve biopsy, a procedure that removes a small piece of nerve for testing. After the standard biopsy, patients often experience discomfort such as swelling and tenderness. The trial will compare patients receiving a synthetic nerve tube for nerve repair with those who do not receive any repair. Ideal participants are those already needing a sural nerve biopsy and who do not have conditions like diabetes or recent major heart problems.

As an unphased trial, this study provides patients the opportunity to contribute to innovative research that could enhance nerve repair techniques.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this nerve repair technique is safe?

Research has shown that using a man-made tube to repair nerves is generally safe. In one study, 82% of patients experienced significant recovery after their nerve repairs, with no related side effects reported. Another study used 3D-printed tubes for nerve repair, also without any side effects. These treatments appear promising in helping nerves heal faster after surgery. While these results are encouraging, individual experiences may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the new approach to neuropathy treatment involving a scaffold biomaterial because it directly addresses nerve repair, which is not a focus of current treatments. Unlike standard care options that mainly manage symptoms or slow disease progression, this method employs a synthetic polymer nerve tube (PCLF) to bridge nerve defects. This innovative technique aims to promote actual nerve regeneration, potentially restoring function more effectively. Additionally, by integrating nerve repair with a biopsy, it offers a comprehensive approach that could lead to better outcomes for patients with neuropathy.

What evidence suggests that this trial's treatments could be effective for neuropathy?

Research has shown that synthetic tubes can aid in nerve repair. Studies have found these tubes to be safer and more effective than traditional methods for repairing sensory nerves. One study found that these tubes can accelerate nerve healing after surgery. In this trial, participants in the "Biopsy + Nerve Repair" arm will undergo nerve repair using these synthetic polymer nerve tubes. This suggests that the nerve repair treatment being tested could help reduce swelling and pain after a nerve biopsy. Meanwhile, participants in the "Biopsy Only" arm will undergo the biopsy procedure without nerve repair. ^{2 6 7 8 9}

Who Is on the Research Team?

Anthony J Windebank, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults aged 18-75 with certain nerve conditions who need a sural nerve biopsy and can follow the study plan. They must have a specific level of nerve signal strength, not smoke, and not be pregnant or breastfeeding. People with recent major heart issues, immune disorders (except thyroid conditions), previous trauma at the biopsy site, or infections like MRSA are excluded.

Inclusion Criteria

I need a biopsy of my sural nerve.

Willingness to complete study procedures

Your sural nerve SNAP has an amplitude of 2 microvolts or more.

Exclusion Criteria

I have had an infection in my joints or soft tissues before.

I have an immune disorder like Crohn's, rheumatoid arthritis, or psoriasis, but not thyroid issues.

You have had an injury at the place where a tissue sample was taken before.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo the surgical procedure of nerve biopsy with or without nerve repair

1 day

1 visit (in-person)

Post-Surgery Monitoring

Participants are monitored for post-surgical reactions and safety, including physical/neurological exams and sural nerve ultrasonography

12 months

Regular clinic or phone evaluations

Long-term Follow-up

Participants are monitored for safety and effectiveness, including assessments of neuroma formation and sensory nerve regeneration

up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

• Biopsy + Nerve Repair
• Biopsy Only

Trial Overview The study is testing the safety of a new biomaterial used in repairing nerves after a biopsy compared to no repair. Participants will either receive this novel scaffold biomaterial during their routine surgery or just undergo the biopsy without any nerve repair.

How Is the Trial Designed?

Group I: Biopsy + Nerve Repair Experimental Treatment 1 Intervention

Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.

Group II: Biopsy Only Placebo Group 1 Intervention

Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4317607/

Clinical outcomes for Conduits and Scaffolds in peripheral ... This study showed promising results in the reconstruction of large caliber, mixed function peripheral nerves using collagen conduits. Dienstknecht et al[46] ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12212433/

Clinically Reducing/Eliminating Chronic Neuropathic Pain ... This paper shows that combining platelet-rich plasma with an autograft within a collagen tube induces rapid long-term chronic neuropathic pain reduction in 11% ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0974322725002947

Review Article Nerve Repair with Nerve Conduits In this review, the authors identify the common applications of nerve conduits, expected results, and shortcomings of current techniques. Furthermore, future ...

4. orthopedicreviews.openmedicalpublishing.org orthopedicreviews.openmedicalpublishing.org/article/133572-regenerative-medicine-a-new-horizon-in-peripheral-nerve-injury-and-repair

Regenerative Medicine: A New Horizon in Peripheral Nerve ... This novel treatment possesses significant potential to accelerate nerve healing after nerve reconstruction and potentially postpone the ...

5. jns-journal.com jns-journal.com/article/S0022-510X(18)30422-2/abstract

Outcome of human peripheral nerve repair interventions ... Results showed that conduits were safe and significantly more effective compared to the conventional sutures in effecting repair of sensory ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7496926/

Peripheral nerve repair throughout the body with ... Overall, 82% meaningful recovery (MR) was achieved across sensory, mixed, and motor nerve repairs up to gaps of 70 mm. No related adverse events ...

7. nature.com nature.com/articles/s43856-024-00438-6

a non-randomised safety and feasibility trial - Nature Bio 3D nerve conduits were successfully used for clinical nerve reconstruction without adverse events and are a possible treatment option for peripheral nerve ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2452199X24005346

Advances in biomaterial-based tissue engineering for ... The study aims to refine strategies, offering a multifaceted perspective to the treatment of peripheral nerve injuries.

9. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-017-0279-4

Clinical and biometrical 12-month follow-up in patients after ... This open, mono-center, non-randomized clinical study summarizes the 12-month follow-up of patients receiving reconstruction of the sural nerve biopsy defect.