Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury
Status:
Unknown status
Trial end date:
2017-09-01
Target enrollment:
Participant gender:
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.