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Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury

Primary Purpose

Peripheral Nerve Injury

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Neovasculgen
Sponsored by
Human Stem Cell Institute, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Nerve Injury focused on measuring Peripheral nerve injury, Neurotmesis, Gene therapy, Plasmid, Nerve regeneration therapy

Eligibility Criteria

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

Inclusion Criteria:

  • Patients with confirmed transection injury between shoulder and wrist
  • Isolated injury of ulnar or median nerve (not mixed injury of several nerves)
  • Nerve injuries which are amenable to direct end-to-end repair
  • Length of the gap between of stumps of transected nerve no longer than 3,5 centimeters
  • Early delayed (secondary) repair performed between 2 to 6 weeks after nerve injury

Exclusion Criteria:

  • Length of the gap between of stumps of transected nerve more than 3,5 centimeters
  • Simultaneous injury of several peripheral nerves
  • Localization of nerve injury beyond of forearm
  • Presence of neurological deficit preceding to nerve injury
  • Systemic disease of connective tissue
  • Myopathy
  • Large surgical procedures planned for next one and a half year
  • Presence of oncological diseases
  • Pregnancy and breastfeeding
  • Alcohol and drug addiction
  • Patient ability to adhere strictly to the rules of the current clinical trial protocol

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Arm Label

    Neovasculgen 1

    Neovasculgen 2

    water for injections

    Arm Description

    Gene therapy drug Neovasculgen will be administered by several intraneural injections after surgical nerve reconstruction before wound closing. A dose is 0,6 mg will be dissolved in 1 ml of aqueous vehicle (water for injection) prior to injection.

    Gene therapy drug Neovasculgen will be administered by several intraneural injections after surgical nerve reconstruction before wound closing. A dose is 1,2 mg will be dissolved in 1 ml of aqueous vehicle (water for injection) prior to injection.

    Instead of the gene therapy drug, 1 ml of aqueous vehicle (water for injections) will be administered by several intraneural injections.

    Outcomes

    Primary Outcome Measures

    Disabilities of the Arm, Shoulder and Hand (DASH) Measure
    The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. Testing has shown that the DASH performs well in both these roles.
    Adverse events

    Secondary Outcome Measures

    Medical Research Council (MRC) Scale for Muscle Strength
    In this scale, muscle strength is graded on a scale from 0 to 5 depending on ability to make whole fall active range of motion and presence of muscle resistance
    The Short Form (36) Health Survey
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    Nerve conduction velocity
    For electrodiagnostic assessment, nerve conduction velocity (NCV) was tested as motor and sensory. The results categorized according to the Yale sensory scale and the severity of sensation and function of the nerves was scored as follows: 0, no sensation; 1, decreased or abnormal sensation; 2, normal sensation.
    Electromyography
    For an EMG, a needle electrode was inserted through the skin into the muscle which injured nerve supplied. The presence, size and shape of the waveform registered and the ability of the muscle to respond when the nerves were stimulated. Also these results scored as follows: 0, no activity; 1, few or single movement; 2, partial activity; 3, full activity.

    Full Information

    First Posted
    January 24, 2015
    Last Updated
    January 28, 2015
    Sponsor
    Human Stem Cell Institute, Russia
    Collaborators
    Kazan Federal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02352649
    Brief Title
    Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury
    Official Title
    1-2 Phase of Safety and Efficacy of Patient Intraneural Injections of VEGF165 Plasmid Gene Therapy on Regeneration After Total Severance or Disruption of the Entire Nerve Fiber
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2015 (undefined)
    Primary Completion Date
    March 2016 (Anticipated)
    Study Completion Date
    September 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Human Stem Cell Institute, Russia
    Collaborators
    Kazan Federal University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine safety and efficacy of pl-vegf165 ("Neovasculgen") for regeneration of peripheral nerve. Pl-vegf165 ("Neovasculgen") is the permitted in Russian Federation angiogenic medication that induce growth of new vessels and included in a complex therapy for patients with peripheral arterial diseases in Russia. It has also been shown to enhance nerve regeneration and muscle reinnervation in animals but these properties have not previously been studied in patients. Moreover, currently there is no method in clinical use to speed the rate of recovery after nerve injury. The objective of this study is to explore the ability of pl-vegf165 to benefit the treatment of patients with peripheral nerve injury. The investigators hypothesize that treatment with intraneural injections with pl-vegf165 after peripheral nerve reconstruction will accelerate nerve regeneration, reduce the period of denervation and improve muscle reinnervation and recovery in patients with peripheral nerve injury.
    Detailed Description
    All patients enrolled into the study will receive standard surgery procedures indicated in accordance with medical care standards for the certain disease. Patients after nerve injury classified as neurotmesis will receive surgical repair of injured nerves what will be added by intraneural injections of pl-vegf165. Safety and efficacy of gene therapy will be assessed by physical examination, comprehensive laboratory tests over next 18 month after surgical nerve reconstruction.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Nerve Injury
    Keywords
    Peripheral nerve injury, Neurotmesis, Gene therapy, Plasmid, Nerve regeneration therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    45 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neovasculgen 1
    Arm Type
    Experimental
    Arm Description
    Gene therapy drug Neovasculgen will be administered by several intraneural injections after surgical nerve reconstruction before wound closing. A dose is 0,6 mg will be dissolved in 1 ml of aqueous vehicle (water for injection) prior to injection.
    Arm Title
    Neovasculgen 2
    Arm Type
    Experimental
    Arm Description
    Gene therapy drug Neovasculgen will be administered by several intraneural injections after surgical nerve reconstruction before wound closing. A dose is 1,2 mg will be dissolved in 1 ml of aqueous vehicle (water for injection) prior to injection.
    Arm Title
    water for injections
    Arm Type
    Placebo Comparator
    Arm Description
    Instead of the gene therapy drug, 1 ml of aqueous vehicle (water for injections) will be administered by several intraneural injections.
    Intervention Type
    Drug
    Intervention Name(s)
    Neovasculgen
    Primary Outcome Measure Information:
    Title
    Disabilities of the Arm, Shoulder and Hand (DASH) Measure
    Description
    The Disabilities of the Arm, Shoulder and Hand (DASH) Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in patients with any or several musculoskeletal disorders of the upper limb. The questionnaire was designed to help describe the disability experienced by people with upper-limb disorders and also to monitor changes in symptoms and function over time. Testing has shown that the DASH performs well in both these roles.
    Time Frame
    540 days
    Title
    Adverse events
    Time Frame
    540 days
    Secondary Outcome Measure Information:
    Title
    Medical Research Council (MRC) Scale for Muscle Strength
    Description
    In this scale, muscle strength is graded on a scale from 0 to 5 depending on ability to make whole fall active range of motion and presence of muscle resistance
    Time Frame
    90 days;180 days; 270 days; 360 days; 450 days; 540 days
    Title
    The Short Form (36) Health Survey
    Description
    The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
    Time Frame
    90 days;180 days; 270 days; 360 days; 450 days; 540 days
    Title
    Nerve conduction velocity
    Description
    For electrodiagnostic assessment, nerve conduction velocity (NCV) was tested as motor and sensory. The results categorized according to the Yale sensory scale and the severity of sensation and function of the nerves was scored as follows: 0, no sensation; 1, decreased or abnormal sensation; 2, normal sensation.
    Time Frame
    180 days; 360 days; 540 days
    Title
    Electromyography
    Description
    For an EMG, a needle electrode was inserted through the skin into the muscle which injured nerve supplied. The presence, size and shape of the waveform registered and the ability of the muscle to respond when the nerves were stimulated. Also these results scored as follows: 0, no activity; 1, few or single movement; 2, partial activity; 3, full activity.
    Time Frame
    180 days; 360 days; 540 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with confirmed transection injury between shoulder and wrist Isolated injury of ulnar or median nerve (not mixed injury of several nerves) Nerve injuries which are amenable to direct end-to-end repair Length of the gap between of stumps of transected nerve no longer than 3,5 centimeters Early delayed (secondary) repair performed between 2 to 6 weeks after nerve injury Exclusion Criteria: Length of the gap between of stumps of transected nerve more than 3,5 centimeters Simultaneous injury of several peripheral nerves Localization of nerve injury beyond of forearm Presence of neurological deficit preceding to nerve injury Systemic disease of connective tissue Myopathy Large surgical procedures planned for next one and a half year Presence of oncological diseases Pregnancy and breastfeeding Alcohol and drug addiction Patient ability to adhere strictly to the rules of the current clinical trial protocol
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Igor Plaksa
    Phone
    +79112171859
    Email
    i.plaksa2014@yandex.ru

    12. IPD Sharing Statement

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    Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury

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