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The primary objective is to evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue, at injection site, after Intra Muscular (IM) administration of increasing single doses of NV1FGF.
Secondary objectives :
- To evaluate the safety and tolerability of IM administration of increasing single doses of NV1FGF
- To evaluate the transgene expression (FGF-1 protein) in injected tissues (injection site and remote site)
- To evaluate the presence of FGF-1 receptors in injected tissues (injection site and remote site)
- To evaluate the NV1FGF biodistribution in injected tissues (injection site and remote site), in multiple organs/tissues when appropriate, and plasma
- To evaluate the transgene expression (synthesis of FGF-1 mRNA) in injected tissue at remote site
- To collect data from plasma NV1FGF pharmacokinetics
- To evaluate healing of the amputation site
Screening of 1 to 4 weeks before study drug administration; Single study drug administration 3 to 8 days before planned amputation; 6 months of follow up
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Peripheral Arterial Occlusive Disease
Published on BioPortfolio: 2014-08-27T03:12:24-0400
The primary objective is to evaluate safety and tolerability of single and repeated administrations of escalating doses of NV1FGF administered intramuscularly in patients with severe Perip...
The primary objective of the study is to demonstrate the superiority of XRP0038/NV1FGF over placebo in the prevention of major amputation above the ankle of the treated leg or of death fr...
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Common occlusive arterial disease which is caused by ATHEROSCLEROSIS. It is characterized by lesions in the innermost layer (ARTERIAL INTIMA) of arteries including the AORTA and its branches to the extremities. Risk factors include smoking, HYPERLIPIDEMIA, and HYPERTENSION.
Pathological processes which result in the partial or complete obstruction of ARTERIES. They are characterized by greatly reduced or absence of blood flow through these vessels. They are also known as arterial insufficiency.
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Regional infusion of drugs via an arterial catheter. Often a pump is used to impel the drug through the catheter. Used in therapy of cancer, upper gastrointestinal hemorrhage, infection, and peripheral vascular disease.
A respiratory stimulant that enhances respiration by acting as an agonist of peripheral chemoreceptors located on the carotid bodies. The drug increases arterial oxygen tension while decreasing arterial carbon dioxide tension in patients with chronic obstructive pulmonary disease. It may also prove useful in the treatment of nocturnal oxygen desaturation without impairing the quality of sleep.
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