UC Davis Health Clinical Studies

A Study of Experimental Combination of CPX-351 and Gemtuzumab Ozogamicin For Relapsed Acute Myeloid Leukemia

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This study will test the experimental combination of two FDA-approved therapies. We will test CPX-351 (also known as Vyxeos) and Gemtuzumab Ozogamicin (also known as Mylotarg). CPX-351 (CPX) is a chemotherapy given through a vein. It is approved for newly diagnosed AML. CPX is a therapy that contains the two chemotherapies daunorubicin and cytarabine. These are the standard chemotherapies that are used in induction therapy for AML. Gemtuzumab Ozogamicin (GO) is a targeted therapy against a protein called “CD33.” This protein is found on 90% of leukemia cells in patients with AML. The combination of these two therapies is considered experimental. This study involves research that tests the safety and effectiveness of giving patients both of these therapies. The main purpose of the study is to determine if this combination of therapy is safe. We know that each therapy individually is safe, but the safety of the combination in relapsed AML is unknown at this time.

Drug study, Phase 1
Any, age 18 years or older

The HOPE-B Trial of Experimental AMT-061 For Severe or Moderately Severe Hemophilia B

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The purpose of this study is to test the safety and effectiveness of a single infusion of the experimental study drug AMT-061. It will be given to adults with severe or moderately severe hemophilia B. AMT-061 is a gene therapy product. Genes contain the blueprint for the body to produce proteins. A damaged or mutated gene can cause the body to produce insufficient levels of a certain protein or stop producing a certain protein at all. In people suffering from hemophilia B, the gene containing the blue print for clotting factor IX, is damaged or mutated. AMT-061 gene therapy targets the liver cells, where factor IX is normally produced. Once AMT061 reaches the liver cells, the capsid (“Package”) releases the gene cassette (“instruction manual”). The capsid is then broken down and disappears. The gene cassette is expected to remain in the liver cells permanently (independent from your own genetic material). The intended result is stable factor IX production in the liver for a long period of time.

Genetic study, Phase 3
Male, age 18 years or older

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
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