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Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

Primary Purpose

Peripheral Nerve Injury Digital Nerve Hand

Status

Unknown status

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

SilkBridge

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury Digital Nerve Hand focused on measuring peripheral nerve injury, nerve guide, silk fibroin, silk, nerve regeneration

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

male & female patients between 18 and 65 years of age
a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint
single lesion per finger
nerve defect of >5mm
nerve treatment initiated within 24 months after nerve injury
signed informed consent

Exclusion Criteria:

disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy
an additional injury that could compromise nerve regeneration
clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult
previous conditions of the hand that could affect the healing of the actual nerve injury
complete amputation injury
extensive crush injury
grossly contaminated wound
receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment
known to be HIV positive
known pregnant and lactating females
participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation
uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation
absence of a healthy opposite finger
suspected allergy to silk
need of emergency surgery (within 24 hours from injury)

Sites / Locations

Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SilkBridge treatment

Arm Description

Surgery for digital nerve reconstruction with SilkBridge

Outcomes

Primary Outcome Measures

Safety of SilkBridge

Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period

Secondary Outcome Measures

Performance - assess at each study visit versus baseline

Sensory recovery after nerve reconstruction by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing Pain evaluation via a visual analog scale (VAS: scale where patient has to specify level of pain by indicating a position along a continuous line between two end-points (0 - 10). 0 indicates no pain while 10 represents the highest level.)

Performance - assess at V5 and at last visit versus opposite control finger

Sensory recovery by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing

Performance - assess at the last visit

Patient's satisfaction through the Patient Global Impression of Change (PGIC) questionnaire (Patient has to describe the change (if any) in activity limitations, symptoms, emotions and overall quality of life, in relation to its painful condition. 0 value represent no change, 7 a considerable improvement).

Full Information

NCT ID

NCT03673449

First Posted

September 12, 2018

Last Updated

March 17, 2020

Sponsor

Silk Biomaterials srl

1. Study Identification

Unique Protocol Identification Number

NCT03673449

Brief Title

Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

Official Title

A Pilot Study to Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

Study Type

Interventional

2. Study Status

Record Verification Date

March 2020

Overall Recruitment Status

Unknown status

Study Start Date

March 22, 2019 (Actual)

Primary Completion Date

March 2021 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Silk Biomaterials srl

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The goal of this study is to ascertain the feasibility and safety of the procedure using SilkBridge - a biocompatible silk fibroin-based scaffold - for the regeneration of sensory nerve fibres and follow it up together with the reinnervation of the target organs (sensory receptors in the skin).

Detailed Description

This is a pre-market, monocentre, first-in-human pilot on adult patients with digital nerve defects. Category C clinical trial, medical devices. The study will be performed in Switzerland. SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments. SilkBridge will provide surgeons with an implant with unique features, such as easy suturability, full biocompatibility and specific biomimetic properties that enhance cells adhesion and integration of the device with the surrounding tissue. The study will have a 12 months and 1 week duration per patient, including the follow-up period, and with an expected enrollment period of 15 months. The study will evaluate 15 adult patients, aged 18-65 years, diagnosed with digital nerve defects (> 5 mm gap) in whom surgical repair may not allow direct suture.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Nerve Injury Digital Nerve Hand

Keywords

peripheral nerve injury, nerve guide, silk fibroin, silk, nerve regeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Open Label Monocentre Study

Masking

None (Open Label)

Allocation

N/A

Enrollment

4 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SilkBridge treatment

Arm Type

Experimental

Arm Description

Surgery for digital nerve reconstruction with SilkBridge

Intervention Type

Device

Intervention Name(s)

SilkBridge

Intervention Description

SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.

Primary Outcome Measure Information:

Title

Safety of SilkBridge

Description

Assess type and severity of adverse device effects related to SilkBridge and surgical procedure throughout the follow-up period

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Performance - assess at each study visit versus baseline

Description

Time Frame

12 months

Title

Performance - assess at V5 and at last visit versus opposite control finger

Description

Sensory recovery by static and moving 2-point discrimination and Semmes-Weinstein monofilament testing

Time Frame

6 and 12 months

Title

Performance - assess at the last visit

Description

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: male & female patients between 18 and 65 years of age a traumatic injury or a post-traumatic neuroma of a digital nerve on the palmar side of the hand, between the metacarpophalangeal joint and the distal interphalangeal joint single lesion per finger nerve defect of >5mm nerve treatment initiated within 24 months after nerve injury signed informed consent Exclusion Criteria: disorders known to affect the peripheral nervous system, such as, but not only, diabetes mellitus, chronic heavy alcohol use, or toxic nerve lesions, or any polyneuropathy an additional injury that could compromise nerve regeneration clinically significant (as defined by the investigator) renal, hepatic, cardiac, endocrine, metabolic, hematologic, autoimmune, or any systemic disease, which may make implementation/interpretation of the protocol or results difficult previous conditions of the hand that could affect the healing of the actual nerve injury complete amputation injury extensive crush injury grossly contaminated wound receiving immunosuppressive or antineoplastic agents within 30 days prior to the enrolment known to be HIV positive known pregnant and lactating females participated in another clinical investigation using an investigational new drug or device (or in the present study) within 30 days prior to enrolment into this investigation uncooperative or unsuitable, e.g. language problems or a suspicion to be unable to attend follow up appointments, for completion of the investigation absence of a healthy opposite finger suspected allergy to silk need of emergency surgery (within 24 hours from injury)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Maurizio Calcagni, MD

Organizational Affiliation

Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich

Official's Role

Principal Investigator

Facility Information:

Facility Name

Klinik für Plastische Chirurgie und Handchirurgie - UniversitätsSpital Zürich

City

Zürich

ZIP/Postal Code

8091

Country

Switzerland

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

25446133

Citation

Faroni A, Mobasseri SA, Kingham PJ, Reid AJ. Peripheral nerve regeneration: experimental strategies and future perspectives. Adv Drug Deliv Rev. 2015 Mar;82-83:160-7. doi: 10.1016/j.addr.2014.11.010. Epub 2014 Nov 14.

Results Reference

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PubMed Identifier

23303520

Citation

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PubMed Identifier

29349931

Citation

Wieringa PA, Goncalves de Pinho AR, Micera S, van Wezel RJA, Moroni L. Biomimetic Architectures for Peripheral Nerve Repair: A Review of Biofabrication Strategies. Adv Healthc Mater. 2018 Apr;7(8):e1701164. doi: 10.1002/adhm.201701164. Epub 2018 Jan 19.

Results Reference

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PubMed Identifier

18804584

Citation

Ichihara S, Inada Y, Nakamura T. Artificial nerve tubes and their application for repair of peripheral nerve injury: an update of current concepts. Injury. 2008 Oct;39 Suppl 4:29-39. doi: 10.1016/j.injury.2008.08.029.

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PubMed Identifier

17565531

Citation

Pfister LA, Papaloizos M, Merkle HP, Gander B. Nerve conduits and growth factor delivery in peripheral nerve repair. J Peripher Nerv Syst. 2007 Jun;12(2):65-82. doi: 10.1111/j.1529-8027.2007.00125.x.

Results Reference

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PubMed Identifier

22090283

Citation

Daly W, Yao L, Zeugolis D, Windebank A, Pandit A. A biomaterials approach to peripheral nerve regeneration: bridging the peripheral nerve gap and enhancing functional recovery. J R Soc Interface. 2012 Feb 7;9(67):202-21. doi: 10.1098/rsif.2011.0438. Epub 2011 Nov 16.

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PubMed Identifier

15363160

Citation

Meek MF, Varejao AS, Geuna S. Use of skeletal muscle tissue in peripheral nerve repair: review of the literature. Tissue Eng. 2004 Jul-Aug;10(7-8):1027-36. doi: 10.1089/ten.2004.10.1027.

Results Reference

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PubMed Identifier

19543442

Citation

Vepari C, Kaplan DL. Silk as a Biomaterial. Prog Polym Sci. 2007;32(8-9):991-1007. doi: 10.1016/j.progpolymsci.2007.05.013.

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PubMed Identifier

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Citation

Thurber AE, Omenetto FG, Kaplan DL. In vivo bioresponses to silk proteins. Biomaterials. 2015 Dec;71:145-157. doi: 10.1016/j.biomaterials.2015.08.039. Epub 2015 Aug 20.

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Citation

De Vita R, Buccheri EM, Pozzi M, Zoccali G. Direct to implant breast reconstruction by using SERI, preliminary report. J Exp Clin Cancer Res. 2014 Nov 25;33(1):78. doi: 10.1186/s13046-014-0078-5.

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Citation

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Evaluate the Reconstruction of Digital Nerve Defects in Humans Using an Implanted Silk Nerve Guide

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