NCT00390767

Safety Study of MultiGeneAngio in Patients With Peripheral Arterial Disease (PAD)

A Phase I Safety, Dose Escalating Study of MultiGeneAngio in Patients With Peripheral Arterial Disease

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: MultiGene Vascular Systems Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• PAD
• Claudication

Interventions

Type	Name	Description
BIOLOGICAL	MultiGeneAngio	Escalating doses of MultiGeneAngio, one dose per patient administered as one treatment, infused intra-arterially

Timeline

• Start date: 2006-10-01
• Primary completion: 2010-12-01
• Completion: 2024-12-01
• First posted: 2006-10-20
• Last updated: 2015-03-05

Locations

2 sites across 1 country: United States