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
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 45
- 主要终点
- Disabilities of the Arm, Shoulder and Hand (DASH) Measure
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •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
研究组 & 干预措施
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.
干预措施: Neovasculgen (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.
干预措施: Neovasculgen (Drug)
结局指标
主要结局
Disabilities of the Arm, Shoulder and Hand (DASH) Measure
时间窗: 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.
Adverse events
时间窗: 540 days
次要结局
- 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)