UC Davis Health Clinical Studies

A Study of Experimental Treatment with OrcaGraft for Allogeneic (donor) Transplant in Hematologic Malignancies (blood cancers)

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This research study will test if experimental OrcaGraft can be safely given to patients. It will be studied as a stem cell transplant in patients with blood cancers and pre-cancerous conditions. We are doing this research because some transplants can cause complications. One complication is called graft-versus-host-disease (GVHD). GVHD causes donor cells to attack recipient tissues. OrcaGraft is designed to minimize or eliminate potential complications and provide a safer transplant. This study will see if OrcaGraft is safe to use. We will also collect data about the best dose of cells that make up a part of OrcaGraft. This could provide data to make the composition of OrcaGraft better in the future. This study is being done at UC Davis Health and at other sites around the U.S.

Biological study, Phase 1
Any, age 18 to 65 years old

A Study of the Safety and Effectiveness of Experimental BIVV003 for Stem Cell Transplant for Severe Sickle Cell Disease

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This research study is being done to see if the investigational product being studied is well-tolerated. We hope to understand the safety of the product, and to see if it improves the health of patients with sickle cell disease. Sickle cell disease is an inherited disorder. Red blood cells become sickle shaped (shaped like a crescent) and rigid. This leads to a variety of serious complications throughout the body. It is possible to replace the abnormal red blood cells in sickle cell patients with normal red blood cells. This is done by a bone marrow transplant from a matched donor. The investigational product to be tested in the present study is known by its code name BIVV003. BIVV003 is made from stem cells that will be collected from your own blood. Stem cells are the primitive cells that make all your blood cells. The stem cells contain the genetic code for making hemoglobin. A portion of that code decides which kind of hemoglobin is made: adult, which is the sickle hemoglobin in your case, or fetal (baby hemoglobin). Bioverativ Therapeutics Inc. has found a way to change this code to make more of the fetal hemoglobin and less of the sickle hemoglobin.

Biological study, Phase [/1/,/ /2/]
Any, age 18 to 35 years old

A Study of the Experimental CorMatrix Cor TRICUSPID ECM Device for Tricuspid Valve Replacement

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This study will determine if the experimental Cor TRICUSPID ECM Valve is a safe replacement of your natural Tricuspid Valve. This is an Early Feasibility Study. That means that it is a small study of a new kind of device. It has only been implanted in a limited number of human subjects. There may be less nonclinical information and testing than would be required to start a larger study. The study is designed to gain initial insights into the basic safety and functionality of the study device. Participation in this study will involve placement of the experimental device Cor TRICUSPID ECM Valve. It will replace your dysfunctional tricuspid heart valve. Over time, the design of the CorMatrix Cor TRICUSPID ECM Valve may allow your own cells to grow into and reconstruct the tricuspid valve structure. This will result in long-term tissue repair with your own natural tissue.

Device study
Any, age 1 to 70 years old

A Study of Experimental Blood Derived Autologous Angiogenic Cell Precursor (type of stem cell) Therapy for Critical Limb Ischemia

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Peripheral Artery Disease (PAD) is a common, progressive circulatory disease. It sometimes advances to Critical Limb Ischemia (CLI). CLI symptoms can be painful and lead to sores and in some cases amputation. This study will test the safety and effectiveness of injecting Angiogenic Cell Precursors (ACPs) into the muscles of your leg and foot. ACPs are specific stem cells collected from your blood. This experimental study treatment will be used to relieve symptoms of Critical Limb Ischemia.

Biological study, Phase 2
Any, age 18 years or older

A Study of Experimental PLX PAD for Critical Limb Ischemia (severely obstructed arteries limiting bloodflow to limbs)

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This study will test if experimental PLX-PAD is safe, well tolerated and effective for the treatment of critical limb ischemia (CLI). This study is for people with CLI, who are not considered good candidates for surgery or other procedures designed to increase blood flow. CLI is a severe form of peripheral artery disease (PAD). It is caused by atherosclerosis (hardening of the arteries due to plaques in their inner walls). When the blood vessels that supply blood to the leg narrow, this leads to insufficient blood and oxygen supply to the leg tissues. CLI may be characterized by pain in the foot or leg even when lying at rest. It can also involve foot and leg wounds, which sometimes lead to infection and tissue death. This may lead to the amputation of toes, foot or leg. PLX-PAD is an experimental medicine. This means that it is not approved for use by the FDA, other than in research studies. PLX-PAD is a cellular therapy, meaning that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta (the organ that connects the fetus to the uterus). It is collected in a sterile procedure during a planned cesarean section, from healthy female volunteers who donated it. All placenta donors complete a comprehensive questionnaire on their risk of being infected or being a carrier of infectious diseases. Their blood is tested for a vast panel of infectious diseases. Since this research uses human cells, the process for obtaining the cells and preparing them for use is subject to the highest standards. PLX-PAD cells are added to a fluid which contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution). The control solution contains: - dimethyl sulfoxide (DMSO), - human serum albumin (human blood protein) - PlasmaLyte (salts solution) The control solution does not contain the PLX-PAD cells and is not expected to make your disease better.

Biological study, Phase 3
Any, age 45 to 99 years old

A Study of the Safety and Effectiveness of Experimental Ralinepag for Patients With Pulmonary Arterial Hypertension

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This study will test an experimental medication called Ralinepag. It will be used in the treatment of pulmonary arterial hypertension (PAH). Ralinepag has not been approved by the FDA and is not available by prescription. Ralinepag is designed to activate the prostacyclin receptor. The prostacyclin receptor is a protein found on cells of blood vessels. A naturally occurring substance called prostacyclin attaches to it. In patients with PAH, reduced activity of the prostacyclin receptors can cause the blood vessels in the lungs to become narrow. This it harder for the blood to flow. By increasing the activity of prostacyclin receptors, we hope that Ralinepag may improve blood flow to the lungs. This may improve symptoms of PAH (shortness of breath while exercising, dizziness, high blood pressure). We are doing this research study to test whether the study drug provides the expected benefits to patients who take it. This study is being done at UC Davis Health and at other sites around the U.S.

Drug study, Phase 3
Any, age 18 to 75 years old

ILUMIEN IV: A Study of OPtical Coherence Tomography (OCT) Guided Coronary Stent IMplantation (OPTIMAL PCI)

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Coronary Stent placement is guided by imaging techniques. The most commonly used technique is Coronary Angiography, which uses x-rays. The doctors in your hospital also use OCT (optical coherence tomography). OCT is an imaging technique. It allows for visualization of the stent and artery wall using light, like having a microspic flashlight placed in your heart artery. The primary purpose of this study is to compare OCT to angiography during coronary stent placement. The physicians participating in this study are experienced users of angiography and OCT in routine clinical practice. There are two phases of the study. The first phase in a roll-in phase. During this time, up to 3 persons at UC Davis will be enrolled who will have the stenting procedure done using OCT. This roll in phase is to show that the physicians can follow the OCT stent guidance procedures. The second phase of the study will enroll persons to be randomized to have the stent placed with angiography or OCT. The study physician will let you know at time of consent if you will be part of the roll-in phase or the randomized phase.

Device study
Any, age 18 years or older

A Study of Experimental Mino-Lok Therapy (MLT) for Catheter-Related or Central Line-Associated Bloodstream Infection

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This research study will test the safety and effectiveness of an experimental drug called Mino-Lok Therapy (MLT). It will be combined with standard of care (SOC) intravenous (IV) antibiotic therapy. This treatment will be compared to antibiotic lock in combination with SOC IV antibiotics. It will be used in catheter-related or central line associated bloodstream infection (CRBSI/CLABSI). The infection is in your central venous catheter (CVC). A CVC is a sterile tube that allows drug to flow from a bottle or bag directly into a patient’s bloodstream. The CVC may get bacteria in it causing an infection to enter the bloodstream. Typically, when a CRBSI/CLABSI occurs, the CVC is replaced. We hope to learn if MLT makes it possible for the CVC not to have to be replaced while treating the bloodstream infection with antibiotics. MLT is a combination of minocycline, edetate disodium, and ethanol. Minocycline and ethanol are designed to disinfect the CVC. Edetate disodium is designed to keep the CVC from clogging. The information we get from this study could help future patients with CRBSI/CLABSIs.

Drug study, Phase 3
Any, age 12 years or older

A Study of the Effects of Sweet Cherry Juice on Metabolism (converting food to energy) and Heart Health

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This research study will test whether regular consumption of cherry juice improves cardiovascular (heart) and metabolic (converting food to energy) health. This study will involve: - daily consumption of study beverages, - tracking study beverage and food consumption in a food diary, - completion of 9 at-home dietary records, - one screening visit and 6 study visits. Here are some reasons you may not want to participate in this research: - You may find frequent test visits at the research center inconvenient and time consuming. - You may find it tedious to: -- drink study beverages, -- limit consumption of certain foods and beverages, -- complete dietary records and questionnaires. - You may find the following procedures uncomfortable: -- blood draws, -- the PAT procedure, -- continuous blood pressure monitoring (CNAP) -- MindWare electrode placement.

Dietary Supplement study
Any, age 20 to 65 years old

A Study of the Long-term Safety of Experimental Tafamidis For Transthyretin Cardiomyopathy

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You have been diagnosed with transthyretin amyloid cardiomyopathy. This is a life-threatening disease involving misfolded protein in the heart. Symptoms include: heart failure, manifested by dyspnea, fatigue, orthostatic hypotension, and/or syncope. Currently there are no FDA approved therapies specific to treating amyloid cardiomyopathy. In a clinical trial, experimental tafamidis was shown to be superior to placebo. It reduced the rate of hospitalizations from cardiac events. It also reduced the rate of death from this disease. The trial enrollment period has ended for this trial. Pfizer is currently pursuing approval in the United States of this drug for TTR amyloid disease. It is not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory agency in the United States. During this study, you will be monitored by your physician in clinic to see how well you are responding to the study drug. The safety of tafamidis will also be evaluated by tracking any adverse events.

Drug study, Phase 3
Any, age 18 years or older
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