Clinical Research
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Contact a clincal coordinator at 650-736-0502
In an effort to provide cutting-edge therapy for patients with vascular disease, and to develop new insights into the mechanisms of vascular disease, the Clinical Research Program in Vascular Medicine at Stanford is spear-heading a number of new clinical trials. Our Clinical Research Group consists of vascular internists and research coordinators with special expertise in carrying out clinical trials in vascular medicine. On-going trials include
GenePAD: Peripheral Arterial Disease (PAD) is a narrowing of the peripheral arteries that can limit blood flow. Typically, this disease affects the arteries supplying the legs with blood. Patients with PAD can experience leg pain with walking, typically an aching in the calves, thighs and/or buttocks (intermittent claudication). When the disease becomes most severe, patients may have pain in the foot at rest, or even ulceration and gangrene. Many patients are asymptomatic. People with PAD are at risk for death or disability due to stroke and myocardial infarction, as well as gangrene and amputation. People with PAD need intensive medical and lifestyle interventions. Because PAD is underdiagnosed (only about 30% of individuals with the disease are diagnosed) clinical tools to identify patients and predict clinical outcomes would be especially efficacious. The Genetic Determinants of Peripheral Arterial Disease (GenePAD) study is a cross-sectional follow-up study in PAD, which commenced in 2004, designed to examine genetic and biomarker associations in PAD. Ongoing follow-up will enable us to evaluate the effect of disease biomarkers and genetic variants on long term PAD morbidity and mortality.Pluristem: Critical limb ischemia is a severe end-point for patients with PAD and is characterized by severe pain, skin ulceration and the possible need for amputation. In fact, up to 200,000 PAD-amputations are performed annually in the United States alone. Currently, many of these patients are treated medically or by surgical revascularization. Pluristem, a bio-therapeutics company based in Haifa, Israel, has developed an allogeneic cell therapy to treat critical limb ischemia that can be administered without need for donor-patient matching. Our group was selected for the phase I clinical trials of this product, called PLX-PAD, which is intended to determine if this treatment is safe, improves quality of life measures, and/or increases the ankle brachial index.
Cytokinetics: Skeletal muscle weakness often occurs in PAD, due to loss of skeletal muscle mass and mitochondriopathy. However, while this weakness can have a profound impact on patient health and quality of life, no therapeutic agents exist to improve skeletal muscle strength. We are currently involved in the ongoing phase I/II clinical trial of a therapy developed by Cytokinetics, which targets the skeletal muscle sarcomere, the most basic unit of skeletal muscle contraction. By directly enhancing the functional performance of the existing skeletal muscle, utilizing small molecule sarcomere activators, this drug could potentially improve patient outcomes in PAD and other muscle wasting pathologies.
Previous trials include:
The NO PAIN study: There is strong evidence that endothelium-derived nitric oxide activity is suppressed in patients with vascular disease. The mechanism of endothelial dysfunction is multifactorial, but ADMA may contribute. In pre-clinical studies, L-arginine supplementation reduces atherogenesis, and enhances therapeutic angiogenesis. Accordingly, in this NIH funded study (Nitric Oxide for Peripheral Arterial Insufficiency), we are examining the effect of L-arginine administration on atherosclerosis and angiogenesis in patients with peripheral arterial disease using magnetic resonance densitometry.
Therapeutic angiogensis for patients with intermittent claudication: Individuals with intermittent claudication are eligible for this study. Intermittent claudication is pain in the calf, thigh, and/or buttocks with walking that is relieved by rest. These symptoms are due to atherosclerosis (hardening of the arteries) affecting the limb arteries. In this trial we will supply additional amounts of one of the body's own growth factors (fibroblast growth factor) in an attempt to cause new blood vessels to form around the obstructions. The intent is to increase blood flow to the legs to relieve the symptoms of claudication.
Therapeutic angiogenesis in critical limb ischemia: Individuals with critical limb ischemia have pain in their legs at rest and perhaps even gangrene or ulceration due to very poor blood flow. In this study, we are using fibroblast growth factor to cause new blood vessels to grow around the obstructions. The intent of this study is to improve blood flow to heal ulcers, gangrene, and to relieve pain.