Advertisement

Topics

Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia

2014-07-23 21:13:41 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and activity of two doses of MultiGeneAngio, a cell therapy product produced from the patient's own cells, as potential treatment for patients with chronic critical limb ischemia.

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 chronic critical limb ischemia due to narrow or blocked leg arteries. 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.

Study Design

Allocation: Randomized, Control: Dose Comparison, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Peripheral Arterial Disease

Intervention

MultiGeneAngio, MultiGeneAngio

Location

Barzilai Medical Center
Ashkelon
Israel
78278

Status

Recruiting

Source

MultiGene Vascular Systems Ltd.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:13:41-0400

Clinical Trials [1418 Associated Clinical Trials listed on BioPortfolio]

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

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...

The Effects of Ramipril on Clinical Symptoms in Patients With Peripheral Arterial Disease

One important clinical challenge in older individuals is maintaining mobility in the absence of pain. Peripheral arterial disease affects up to 12% of adults over 50 and impairs quality of...

Etiology and Prevalence of Peripheral Arterial Disease

To determine the prevalence of peripheral arterial disease in a defined population by non-invasive techniques; to evaluate the association of cardiovascular disease risk factors with perip...

Natriuretic Peptide for the Treatment of Peripheral Arterial Disease (Cen-Walk)

This study proposes the use of a novel medication, cenderitide, designed by molecular engineering, to test the effects on pain free walking duration for patients with peripheral arterial d...

FGF-1 for Intramuscular Injection for the Treatment of Peripheral Arterial Disease

FGF-1 for the treatment of patients with peripheral arterial disease with intermittent claudication.

PubMed Articles [17528 Associated PubMed Articles listed on BioPortfolio]

Environmental tobacco smoke and peripheral arterial disease: A review.

Despite worldwide reductions in active smoking, non-smokers continue to be exposed to environmental tobacco smoke, especially at home or workplace. There is a well-recognised association between activ...

Anti-inflammatory agents in peripheral arterial disease.

Inflammation is pivotally involved in coronary and peripheral atherosclerotic disease. This established concept is based on both experimental animal models of vascular inflammation and Mendelian rando...

Association of Vitamin D deficiency with peripheral arterial disease: a meta-analysis of literature studies.

Vitamin D deficiency patients have an increased cardiovascular (CV) morbidity and mortality. Contrasting data are available about the association between peripheral arterial disease (PAD) and Vitamin ...

Risk of acute coronary syndrome and peripheral arterial disease in chronic liver disease and cirrhosis: A nationwide population-based study.

Until now, no study has investigated the risks of acute coronary syndrome (ACS) and peripheral arterial disease (PAD) in cirrhosis.

Lower limb arterial calcification (LLAC) scores in patients with symptomatic peripheral arterial disease are associated with increased cardiac mortality and morbidity.

The association of coronary arterial calcification with cardiovascular morbidity and mortality is well-recognized. Lower limb arterial calcification (LLAC) is common in PAD but its impact on subsequen...

Medical and Biotech [MESH] Definitions

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.

Lack of perfusion in the EXTREMITIES resulting from atherosclerosis. It is characterized by INTERMITTENT CLAUDICATION, and an ANKLE BRACHIAL INDEX of 0.9 or less.

Thickening and loss of elasticity of the walls of medium and large muscular ARTERIES with lesions in the innermost layer of the artery (ARTERIAL INTIMA). This disease process of atherogenesis includes the retention of cholesterol-rich LIPOPROTEINS and their binding to PROTEOGLYCANS in the arterial intima, generation of proinflammatory molecules that recruit MACROPHAGES to the subendothelial space, formation of FOAM CELLS, and eventual calcification of the arterial wall. These arterial plaques (atheromas) contain CARBOHYDRATES; BLOOD; and CALCIUM.

Comparison of the BLOOD PRESSURE between the BRACHIAL ARTERY and the POSTERIOR TIBIAL ARTERY. It is a predictor of PERIPHERAL ARTERIAL DISEASE.

More From BioPortfolio on "Safety Study of MultiGeneAngio in Patients With Chronic Critical Limb Ischemia"

Advertisement
Quick Search
Advertisement
Advertisement

 

Searches Linking to this Trial