Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist

Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist

The purpose of this open, multicenter trial is to assess the impact of a nerve regeneration conduit made of allogeneic artery or vein from umbilical cord lining on the regeneration of wrist nerve.

Study Overview

• Status: Recruiting
• Conditions: Nerve Injury; Nerve Lesion
• Intervention / Treatment: Biological: NerVFIX

• Study Type: Interventional
• Enrollment (Anticipated): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• France
  • Saint-Herblain, France, 44800
    • Recruiting
    • Clinique de la Main - Nantes Atlantique
    • Contact: Ludovic ARDOUIN, MD; Email: ardouin.ludo@gmail.com
    • Principal Investigator: Ludovic ARDOUIN, MD
  • Villeurbanne, France, 69100
    • Recruiting
    • Institut Chirurgical de la Main et du Membre Supérieur
    • Contact: Lionel ERHARD, MD; Email: lionel.erhard@institut-chirurgical.com
    • Principal Investigator: Lionel ERHARD, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Men and women over 18 years of age and under 65 years of age
• One wrist nerve section ( medial, ulnar) with a minimum of 2 mm and maximum gap of 2 cm evaluated during the surgical procedure (Sunderland Grade V)
• Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nerve junction
• Poor outcome on the Mackinnon-Dellon scale: < S3
• Within 1 month of the injury or accident event and/or at the time of the injury (emergency procedure)
• Any damaged artery must be repaired
• Patient with no poor vascularization risk (no surgical treatment of vessel section) or no disease linked to poor vascularization.
• Patient who received the study information and provided consent
• Patients who are members or the beneficiary of a national health insurance plan

Exclusion Criteria:

• Breast feeding women or women without effective contraception (if no effective contraception: a pregnancy test is mandatory)
• Digital nerve section
• Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method
• Patient who suffered amputation of the hand in question
• Surgical site infection or necrotic area; tendon and/or bone damage
• Underlying motor or sensory disorder that could compromise the evaluation; inflammatory arthritis causing pain
• Disease that compromises healing such as diabetes, alcoholism or skin disorder
• Vascular disease leading to reduced blood flow or altered microvascularisation such as Raynaud's disease
• Subjects who are unlikely to follow through with rehabilitation or who could be addicted to drugs or alcohol; heavy smokers will be asked to stop smoking voluntarily
• Persons confined by a judicial or administrative decision
• Adults subject to legal protection measures or who are unable to provide their consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NerVFIX; Biological regeneration nerve conduit of allogeneic artery or vein from umbilical cord used as a conduit for gap < 2 cm or as a wrap after peripheral nerve suture	Biological: NerVFIX; Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recovery of sensory function	Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progressive recovery of sensory function	Improvement in the s2PD	15 days, 1 month, 3 months, 6 months, 12 months
Decrease of the score of symptoms related to nerve section	Score of cold sensitivity, hyperaesthesia and numbing (0 = no complication, 4 = major complication) and score of pain to the pressure (0 = no pain, 10 = worst imaginable pain)	15 days, 1 month, 3 months, 6 months, 12 months
Improvement of the touch-pressure threshold of the hand	Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests	15 days, 1 month, 3 months, 6 months, 12 months
Percentage of nerve regeneration	Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign	1 month, 3 months, 6 months, 12 months
Improvement of health-related quality of life	Quality of life related to nerve section of the hand evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability)	15 days, 1 month, 3 months, 6 months, 12 months
Improvement of clinical motricity	Improvement of thumb opposition in case of median nerve section or of Froment's sign, abduction and adduction of the fingers and movement of the 4th and 5th digit in case of ulnar nerve section	15 days, 1 month, 3 months, 6 months, 12 months

Collaborators and Investigators

• Sponsor: TBF Genie Tissulaire

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: December 30, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 20, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 28, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: NerVFIX-TBF2; 2019-A03050-57 (Registry Identifier: IDRCB)

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: No