Claudication Clinical Trial
Official title:
A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease
The purpose of this study is to evaluate the safety and activity of increasing doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with peripheral arterial disease.
Approximately 16 million patients worldwide (1 in 20 people over the age of 50) suffer from
peripheral arterial disease(PAD). PAD is characterized by narrowing or occlusion of vessels
supplying blood to the lower limbs, most often due to atherosclerosis. Symptoms of PAD
include claudication that may progress to critical limb ischemia manifested by rest pain,
tissue loss and gangrene, which eventually may necessitate amputation.
MultiGeneAngio is a cell therapy-based product developed for treatment of patients with PAD
secondary to narrow or blocked arteries in the legs. MultiGeneAngio is composed of
endothelial and smooth muscle cells that are isolated from a short vein segment stripped
from the patient's arm. After isolation the cells are expanded, characterized, and gene
modified by transfer of angiogenic genes.
MultiGeneAngio is a clear cell suspension injected intra-arterially at the site of blockage
using a standard diagnostic catheter, in order to create and expand new collateral arteries,
and thereby improve blood flow to an ischemic limb.
Comprehensive pre-clinical studies, as well as clinical experience with PAD patients
suffering from claudication showed that production and administration of MultiGeneAngio was
feasible and safe, as no apparent drug-related adverse events have been observed. Moreover,
follow-up data of peak walking times imply a beneficial trend of this efficacy end-point.
Additional follow-up data will continue to be collected to help evaluate the safety and
efficacy of MultiGeneAngio.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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