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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

This is safety study. Subjects will be undergoing the surgical procedure of nerve biopsy. After routine surgery without grafting, patients develop swelling, redness, tenderness and dysesthesia at the biopsy site. In order to determine whether grafting is safe compared to not repairing the nerve, it is necessary to compare treated vs. untreated patients using systematic, sensitive and reproducible criteria.

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 data supports the effectiveness of the treatment Biopsy + Nerve Repair, Biopsy Only for neuropathy?

Research shows that using bioresorbable materials and neural scaffolds can help nerve regeneration, which is important for treating nerve damage. These materials have been used successfully in animal studies to support nerve healing, suggesting they might be helpful in similar human treatments. ^{1 2 3 4 5}

Is the scaffold biomaterial for neuropathy safe for humans?

The safety of nerve guidance conduits and wraps, which are similar to scaffold biomaterials, has been reviewed and approved by the FDA for peripheral nerve repair. These materials, made from both natural and synthetic substances, have been evaluated for safety in clinical settings, indicating they are generally safe for human use. ^{1 2 6 7 8}

How is the treatment Biopsy + Nerve Repair unique for treating neuropathy?

This treatment is unique because it uses a scaffold biomaterial, which is a structure that supports nerve regeneration, potentially offering a more effective alternative to traditional nerve grafts. The use of biomimetic (nature-inspired) scaffolds can enhance nerve repair by mimicking the natural environment of nerves, which may improve healing outcomes compared to standard treatments. ^{1 2 4 9 10}

Research Team

Anthony J Windebank, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Regeneration of rat sciatic nerve across a LactoSorb bioresorbable conduit with interposed short-segment nerve grafts. [2019]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Fate and contribution of induced pluripotent stem cell-derived neurospheres transplanted with nerve conduits to promote peripheral nerve regeneration in mice. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Side-to-side supercharging nerve allograft enhances neurotrophic potential. [2020]

4. England pubmed.ncbi.nlm.nih.gov

Biomimetic neural scaffolds: a crucial step towards optimal peripheral nerve regeneration. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

An Experimental Study to Bridge a Nerve Gap with a Decellularized Allogeneic Nerve. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Development of an acellular nerve cap xenograft for neuroma prevention. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

FDA approved guidance conduits and wraps for peripheral nerve injury: a review of materials and efficacy. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Mechanism of Peripheral Nerve Regeneration Using a Bio 3D Conduit Derived from Normal Human Dermal Fibroblasts. [2021]

9. China pubmed.ncbi.nlm.nih.gov

[Repair of peripheral nerve defect by xenogeneic acellular nerve basal lamina scaffolds]. [2011]

10. United States pubmed.ncbi.nlm.nih.gov

A clinical multi-center registry study on digital nerve repair using a biodegradable nerve conduit of PGA with external and internal collagen scaffolding. [2020]