Nerve InjuryPhase 2NCT05199155
Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist
A Phase 2 study testing NerVFIX in people with Nerve Injury and Nerve Lesion, run by TBF Genie Tissulaire at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nerve Injury, Nerve Lesion
- What is being tested?
- NerVFIX
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesFrance
- Study dates
- 8 Dec 2020to 13 Aug 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
France2 sites
Clinique de la Main - Nantes Atlantique
Saint-Herblain, 44800
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, 69100
About this study
Official title: 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.
- Conditions
- Nerve Injury, Nerve Lesion
- Being tested
- NerVFIX
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerVFIXBiological
Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit
| Study group | Role | What they receive |
|---|---|---|
| NerVFIX | Experimental | 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 Receives: Biological: NerVFIX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of sensory function
Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)
Measured: 12 months
Secondary outcomes (6)
Progressive recovery of sensory function
Improvement in the s2PD
Measured: 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)
Measured: 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
Measured: 15 days, 1 month, 3 months, 6 months, 12 months
Percentage of nerve regeneration
Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign
Measured: 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)
Measured: 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
Measured: 15 days, 1 month, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start8 Dec 2020
- Primary completion13 Aug 2024
- Study completion13 Aug 2024
Why it stopped: Low accrual rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nerve InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- TBF Genie Tissulaire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199155
- Sponsor's protocol ID
- NerVFIX-TBF2
- Other IDs
- 2019-A03050-57
- Status last verified
- Nov 2024
- First submitted
- 30 Dec 2021
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study Evaluating the Safety and Efficacy of NerVFIX Treatment for Trauma or Accidental Nerve Section of the Wrist
- ClinicalTrials.gov ID
- NCT05199155
- Acronym / sponsor ID
- NerVFIX-TBF2
- Conditions
- Nerve Injury, Nerve Lesion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual rate
- Enrolment
- 12 participants (actual)
- Lead sponsor
- TBF Genie TissulaireIndustry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 13 Aug 2024 (actual)
- Study completion
- 13 Aug 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NerVFIX | Experimental | Biological: NerVFIXBiological 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NerVFIXDecellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit | Biological | NerVFIX |
Primary outcome
Recovery of sensory function
Time frame: 12 months
Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)
6 secondary outcomes
Progressive recovery of sensory function
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Decrease of the score of symptoms related to nerve section
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Improvement of the touch-pressure threshold of the hand
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Percentage of nerve regeneration
Time frame: 1 month, 3 months, 6 months, 12 months
Improvement of health-related quality of life
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Improvement of clinical motricity
Time frame: 15 days, 1 month, 3 months, 6 months, 12 months
Results and safety
The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NerVFIX in people with Nerve Injury and Nerve Lesion, run by TBF Genie Tissulaire at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low accrual rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of sensory function (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2024.