Safety and Efficacy Study of Neovasculgen (Pl-VEGF165) Gene Therapy in Patients With Peripheral Nerve Injury
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|ClinicalTrials.gov Identifier: NCT02352649|
Recruitment Status : Unknown
Verified January 2015 by Human Stem Cell Institute, Russia.
Recruitment status was: Not yet recruiting
First Posted : February 2, 2015
Last Update Posted : February 2, 2015
|Condition or disease||Intervention/treatment||Phase|
|Peripheral Nerve Injury||Drug: Neovasculgen||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|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 Start Date :||April 2015|
|Estimated Primary Completion Date :||March 2016|
|Estimated Study Completion Date :||September 2017|
Experimental: 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.
Experimental: 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.
Placebo Comparator: water for injections
Instead of the gene therapy drug, 1 ml of aqueous vehicle (water for injections) will be administered by several intraneural injections.
- Disabilities of the Arm, Shoulder and Hand (DASH) Measure [ Time Frame: 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 [ Time Frame: 540 days ]
- Medical Research Council (MRC) Scale for Muscle Strength [ Time Frame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days ]In this scale, muscle strength is graded on a scale from 0 to 5 depending on ability to make whole fall active range of motion and presence of muscle resistance
- The Short Form (36) Health Survey [ Time Frame: 90 days;180 days; 270 days; 360 days; 450 days; 540 days ]The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
- Nerve conduction velocity [ Time Frame: 180 days; 360 days; 540 days ]For electrodiagnostic assessment, nerve conduction velocity (NCV) was tested as motor and sensory. The results categorized according to the Yale sensory scale and the severity of sensation and function of the nerves was scored as follows: 0, no sensation; 1, decreased or abnormal sensation; 2, normal sensation.
- Electromyography [ Time Frame: 180 days; 360 days; 540 days ]For an EMG, a needle electrode was inserted through the skin into the muscle which injured nerve supplied. The presence, size and shape of the waveform registered and the ability of the muscle to respond when the nerves were stimulated. Also these results scored as follows: 0, no activity; 1, few or single movement; 2, partial activity; 3, full activity.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02352649
|Contact: Igor Plaksafirstname.lastname@example.org|