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

TBF Genie Tissulaire2 sites in 1 country12 target enrollmentDecember 8, 2020

ConditionsNerve Injury Nerve Lesion

InterventionsNerVFIX

DrugsNerVFIX

Overview

Phase: Phase 2
Intervention: NerVFIX
Conditions: Nerve Injury
Sponsor: TBF Genie Tissulaire
Enrollment: 12
Locations: 2
Primary Endpoint: Recovery of sensory function
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 8, 2020

End Date

August 13, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

TBF Genie Tissulaire

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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

Intervention: NerVFIX

Outcomes

Primary Outcomes

Recovery of sensory function

Time Frame: 12 months

Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)

Secondary Outcomes

Progressive recovery of sensory function(15 days, 1 month, 3 months, 6 months, 12 months)
Decrease of the score of symptoms related to nerve section(15 days, 1 month, 3 months, 6 months, 12 months)
Improvement of the touch-pressure threshold of the hand(15 days, 1 month, 3 months, 6 months, 12 months)
Percentage of nerve regeneration(1 month, 3 months, 6 months, 12 months)
Improvement of health-related quality of life(15 days, 1 month, 3 months, 6 months, 12 months)
Improvement of clinical motricity(15 days, 1 month, 3 months, 6 months, 12 months)