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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02352649
Recruitment Status : Unknown
Verified January 2015 by Human Stem Cell Institute, Russia.
Recruitment status was:  Not yet recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
Sponsor:
Collaborator:
Kazan Federal University
Information provided by (Responsible Party):
Human Stem Cell Institute, Russia

Study Description
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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.

Condition or disease Intervention/treatment Phase
Peripheral Nerve Injury Drug: Neovasculgen Phase 1 Phase 2

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : April 2015
Estimated Primary Completion Date : March 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Neovasculgen 1
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.
 Drug: Neovasculgen
Experimental: Neovasculgen 2
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.
 Drug: Neovasculgen
Placebo Comparator: water for injections
Instead of the gene therapy drug, 1 ml of aqueous vehicle (water for injections) will be administered by several intraneural injections.


Outcome Measures
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Primary Outcome Measures :
  1. Disabilities of the Arm, Shoulder and Hand (DASH) Measure [ Time Frame: 540 days ]
    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.

  2. Adverse events [ Time Frame: 540 days ]

Secondary Outcome Measures :
  1. Medical Research Council (MRC) Scale for Muscle Strength [ Time Frame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days ]
    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

  2. The Short Form (36) Health Survey [ Time Frame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days ]
    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.

  3. Nerve conduction velocity [ Time Frame: 180 days; 360 days; 540 days ]
    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.

  4. Electromyography [ Time Frame: 180 days; 360 days; 540 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352649


Contacts
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Contact: Igor Plaksa +79112171859 i.plaksa2014@yandex.ru

Sponsors and Collaborators
Human Stem Cell Institute, Russia
Kazan Federal University
More Information
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Responsible Party: Human Stem Cell Institute, Russia
ClinicalTrials.gov Identifier: NCT02352649    
Other Study ID Numbers: Neurotmesis
First Posted: February 2, 2015    Key Record Dates
Last Update Posted: February 2, 2015
Last Verified: January 2015
Keywords provided by Human Stem Cell Institute, Russia:
Peripheral nerve injury
Neurotmesis
Gene therapy
Plasmid
Nerve regeneration therapy
Additional relevant MeSH terms:
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Peripheral Nerve Injuries
Wounds and Injuries
Peripheral Nervous System Diseases
 Neuromuscular Diseases
Nervous System Diseases
Trauma, Nervous System