Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

A Clinical Trial to Assess the Safety of a Novel Scaffold Biomaterial

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Amyloidosis; Peripheral Neuropathy; Chronic Inflammatory Demyelinating Polyradiculoneuropathy; Vasculitic Neuropathy (Disorder); Hereditary Neuropathy; Sarcoid Neuropathy
• Intervention / Treatment: Device: Biopsy + Nerve Repair; Procedure: Biopsy Only

Detailed Description

Patients will be evaluated for eligibility and then, after gaining informed consent, the surgical procedure will be scheduled. Baseline evaluations include physical/neurological examination, nerve conduction study and ultrasonography of the sural nerve, and testing for erythrocyte sedimentation rate, C-reactive protein and complete blood counts (with white blood cell differential). Surgery is done in an operating room under local or monitored anesthesia, depending on patient preference. An incision will be made above the ankle. Immediately after the surgery, the patient will repeat the baseline physical/neurological exams, and sural nerve ultrasonography.

Participants will be evaluated either in the clinic or by phone on a regular basis and will be required to keep a journal and fill out symptom questionnaires for up to 12 months post-procedure.

Development of a grade 4 local reaction at any time will fulfill criteria for review by the Data and Safety Monitoring Board (DSMB) for implant removal and definition as a failure.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic in Rochester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria

• Are between the ages of 18-75 years
• Have clinical indications for whole sural nerve biopsy
• Have a sural nerve SNAP with amplitude > or = 2 microvolt (μV)
• Are able to comply with protocol requirements
• Can provide written informed consent
• Willingness to complete study procedures

Exclusion Criteria

• Current smoker.
• History of prior musculoskeletal (joint or soft tissue) infection.
• Pre-operative nares culture positive for methicillin-resistant Staphylococcus Aureus (MRSA) or methicillin-sensitive Staphylococcus Aureus (MSSA)
• Have systemic immune disorders, such as Crohn's Disease, rheumatoid arthritis, or psoriasis with the exception of hyper/hypothyroidism.
• Have diabetes mellitus.
• Have previous trauma to the biopsy site.
• Have any major, clinically significant medical condition (e.g., within six months of baseline, had myocardial infarction, angina pectoris, and/or congestive heart failure) that, in the opinion of the investigator, would compromise the safety of patient.
• Are pregnant or breast-feeding.
• Unwilling to use adequate contraception.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Biopsy + Nerve Repair; Subjects will undergo standard sural nerve biopsy plus repair of the 6 cm nerve defect using a synthetic polymer (PCLF) nerve tube.	Device: Biopsy + Nerve Repair; During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.
Sham Comparator: Biopsy Only; Subjects will undergo the same standard sural nerve biopsy procedure as the Experimental Group, but will not include the nerve repair.	Procedure: Biopsy Only; Standard sural nerve biopsy only, without nerve repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety as determined by number of participants with post-surgical reactions	Post-surgical reactions will include evaluations of the following: Percussion tenderness at site of proximal stump or repair site;; Skin redness at the site of biopsy (length and width measured with calipers);; Development of mild or moderate swelling along the site (yes or no). It is anticipated that this will resolve to a lower grade or progress to grade 4.; Development of severe swelling or pustules or evidence of tube extrusion or wound dehiscence.	up to 5 years post surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropathic pain as measured by SNAP	Sensory nerve action potential (SNAP) will be measured at the ankle using small electric shocks and recording pads on the skin. This will be done by an experienced and board-certified electrophysiologist.	3 months & 12 months
Neuroma formation	Non-invasive nerve ultrasound will be performed to determine neuroma formation	3 months & 12 months
Sensory nerve regeneration as measured by SNAP	The amplitude of sensory nerve action potential (SNAP) will be used to determine sensory nerve regeneration	3 months & 12 months
Sensory nerve regeneration as measured by ultrasound	Non-invasive nerve ultrasound will be performed to determine sensory nerve regeneration	3 months & 12 months
Neuropathic pain as measured by visual analogue pain scale	The Visual Analogue Scale (VAS) consists of a straight line with the endpoints of 'No pain' and 'Pain as bad as it could possibly be'. The subject is asked to mark his or her pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark defines the subject's pain.	weekly, monthly for first 3 months, then 12 months and yearly for 4 years
Neuropathic pain as measured by visual analogue pain assessment questionnaire	Subjects will be asked to check all of the following that apply: 1) fever, 2) unexplained or new joint aches and pain, 3) increased skin redness at or near the site of the biopsy, 4) increased swelling at or near the site of the biopsy, 5) some degree of pain or discomfort at or near the site of the biopsy	weekly, monthly for first 3 months, then 12 months and yearly for 4 years

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Anthony J Windebank, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): November 9, 2018
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: May 11, 2018
• First Submitted That Met QC Criteria: July 10, 2018
• First Posted (Actual): July 12, 2018

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 27, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pathologic Processes; Neuromuscular Diseases; Chronic Disease; Disease Attributes; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Proteostasis Deficiencies; Polyneuropathies; Polyradiculoneuropathy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Peripheral Nervous System Diseases; Amyloidosis; Polyradiculoneuropathy, Chronic Inflammatory Demyelinating; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Biopsy
• Other Study ID Numbers: 17-008763

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No