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

NCT ID: NCT02352649

Last Updated: 2015-02-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2017-09-30

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.

Conditions

Peripheral Nerve Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Neovasculgen

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Neovasculgen

Intervention Type: DRUG

water for injections

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

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Neovasculgen

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kazan Federal University

OTHER

Sponsor Role: collaborator

Artgen Biotech

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Igor Plaksa

Role: CONTACT

i.plaksa2014@yandex.ru

+79112171859

Other Identifiers

Neurotmesis

Identifier Type: -

Identifier Source: org_study_id