Clinical trial NCT02352649: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Peripheral Nerve Injury
Keywords: Peripheral nerve injury
Neurotmesis
Gene therapy
Plasmid
Nerve regeneration therapy
Lead sponsor: Human Stem Cell Institute, Russia
Sponsor class: OTHER
Collaborators: name: Kazan Federal University
First posted: 2015-02-02
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Measure
timeFrame: 540 days
measure: Adverse events
timeFrame: 540 days
Secondary outcomes:
measure: Medical Research Council (MRC) Scale for Muscle Strength
timeFrame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days
measure: The Short Form (36) Health Survey
timeFrame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days
measure: Nerve conduction velocity
timeFrame: 180 days; 360 days; 540 days
measure: Electromyography
timeFrame: 180 days; 360 days; 540 days
Other outcomes:
Locations:
Study officials:
References: