Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury
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
1 other identifier
interventional
45
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Apr 2015
Typical duration for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 24, 2015
CompletedFirst Posted
Study publicly available on registry
February 2, 2015
CompletedStudy Start
First participant enrolled
April 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2017
CompletedFebruary 2, 2015
January 1, 2015
11 months
January 24, 2015
January 28, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
540 days
Adverse events
540 days
Secondary Outcomes (4)
Medical Research Council (MRC) Scale for Muscle Strength
90 days;180 days; 270 days; 360 days; 450 days; 540 days
The Short Form (36) Health Survey
90 days;180 days; 270 days; 360 days; 450 days; 540 days
Nerve conduction velocity
180 days; 360 days; 540 days
Electromyography
180 days; 360 days; 540 days
Study Arms (3)
Neovasculgen 1
EXPERIMENTALGene 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.
Neovasculgen 2
EXPERIMENTALGene 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.
water for injections
PLACEBO COMPARATORInstead of the gene therapy drug, 1 ml of aqueous vehicle (water for injections) will be administered by several intraneural injections.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Artgen Biotechlead
- Kazan Federal Universitycollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 24, 2015
First Posted
February 2, 2015
Study Start
April 1, 2015
Primary Completion
March 1, 2016
Study Completion
September 1, 2017
Last Updated
February 2, 2015
Record last verified: 2015-01