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UC Davis Health Clinical Studies

A Study of Renal Anhydramnios Fetal Therapy (repeated infusions of replacement amniotic fluid into the womb)

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This research is being done to test repeated infusions of replacement amniotic fluid into the womb. We hope this can reliably rescue the lung function of fetuses that do not make urine, and as a result, have no amniotic fluid. This condition occurs when the fetus has a severe birth defect called congenital bilateral renal agenesis (CoBRA). It can also be caused by fetal renal failure (FRF). We hope to discover whether this fetal intervention can make early pregnancy renal anhydramnios, called EPRA, reliably survivable after birth. We are also doing this study to better understand what happens to EPRA fetuses in the womb that do not receive therapy. During EPRA, the fetus does not have well-developed or functional kidneys and does not make urine. Fetal urine makes up what we commonly call amniotic fluid. This fluid surrounds the fetus and performs many vital functions. The most important function of amniotic fluid is to allow development of the lungs. In normal fetal life, the fetus gets oxygen and releases carbon dioxide through the placenta. Because gas exchange occurs in the placenta, the lungs do not need to function in the womb. They do need to go through a complex developmental process to be ready to work after birth. This developmental process involves the formation of tiny sacs called alveoli in the lungs. They allow the baby to absorb oxygen from the air it breathes in and expel carbon dioxide from the air it breathes out once born. A critical part of the formation of these alveoli is the fluid that fills the lungs during fetal life. The fluid made by the fetus’s lungs causes the alveoli to stretch and grow. If there is no amniotic fluid in the womb, the lung fluid easily escapes from the lungs and cannot perform its vital function of making the alveoli grow. Normally, the amniotic fluid creates enough pressure in the womb to keep the lung fluid in the lungs. Since the amniotic fluid and the lung fluid connect when the fetus opens its mouth and windpipe, the pressure of the amniotic fluid pushes on the lung fluid. This pressure on the lung fluid must be present for the alveoli to develop correctly. Even if the baby’s lungs work well enough after birth for the baby to survive, the baby will still have no kidneys and need dialysis. A pediatric surgeon will need to place a dialysis catheter into the baby’s abdomen. This will allow fluid and toxins to be removed from the baby as a replacement for kidney function and urination. This process is commonly known as peritoneal dialysis. The baby may also need special assistance with feeding and breathing. All of this requires advanced neonatal care in a neonatal intensive care unit (NICU). It is likely that surviving babies will need to be in the NICU for several months before being able to go home. There are frequent challenges with peritoneal dialysis. This includes infection and dialysis catheter malfunction. Not all babies survive because of complications that can arise from peritoneal dialysis. Additionally, surviving babies will eventually need a kidney transplant to survive long-term. Current survival for infants with complete renal failure who survive to receive a kidney transplant is about 70-80%. Organs can come from either living or deceased donors. They require the baby to take medicine every day to prevent his or her body from rejecting the donated kidney. These babies also have problems with the urinary system that normally drains urine from the kidneys namely the bladder and the urethra. This will become an issue after kidney transplant because the urine will need a place to drain and be expelled. A urologic surgeon will need to be involved to help manage this. He or she may need to make a new bladder out of intestine or do other reconstructive surgery.

Procedure study
Female, age 18 to 60 years old

A Study of Experimental AB-205 in Adults With Lymphoma Undergoing Autologous (from self) Stem Cell Transplantation

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You are invited to be in this study because you have lymphoma. A clinical trial is a type of research study. We do research studies to try to answer questions about how to prevent, diagnose, and treat diseases like cancer. Clinical trials include only people who choose to take part. This is a first in-human study. The purpose of this research is to find out if the experimental product, AB-205, is safe. AB-205 is made up of engineered (modified) human endothelial cells. The endothelial cells are cells that line the inside of blood vessels including the umbilical cord. AB-205 is made from human umbilical endothelial cells that are collected from the umbilical cord of a healthy newborn baby. This research study will test the safety of a single dose infusion of AB-205, given after a bone marrow transplant. The study goal is to test the highest dose of AB-205 to be given in humans with Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). Patients are in a chemo-sensitive remission undergoing high-dose therapy (HDT), with or without radiation. Participants have an autologous stem cell transplant. This is a type of transplant in which a person’s own stem cells are taken, preserved and returned to them.

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

A Study of Gene Edited Autologous Neoantigen Targeted TCR T Cells With or Without Anti-PD-1 in Patients With Solid Tumors

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The purpose of this study is to test the safety and effectiveness of an experimental cancer treatment called NeoTCR-P1. This is a research study for people who have been diagnosed with cancer. Specifically: - advanced melanoma, - bladder cancer, - colorectal cancer, - ovarian cancer, - breast cancer, or - prostate cancer The study is for patients whose cancer has gotten worse after standard therapy and no additional therapies are available. This research study will take some of your own white blood cells, modify them in a laboratory, and re-infuse them back into you. White blood cells are part of the body’s immune system. They help the body fight infection and other immune diseases. Types of white blood cells are granulocytes (neutrophils, eosinophils, and basophils), monocytes, and lymphocytes (T-cells and B-cells). In this study, your T-cells will be modified so that they can identify and possibly kill your cancer cells. Cancer cells have markers, called “neoantigens”, on their surface that are unique and specific to each person’s tumor. You can think of neoantigens as a tumor’s hidden fingerprint. Your T-cells will be modified to recognize your tumor’s specific neoantigen. The modification is a genetic change, or gene transfer, to your normal T-cells. This means that a section of DNA (genetic material) in your T-cells will be replaced. A specific DNA sequence will be put in its place to help your T-cells identify and locate your tumor cells. A receptor is a protein molecule on a cell’s surface. It receives chemical signals from outside the cell and translates them into a response inside the cell. This modification will add a new receptor to your T-cells so that they recognize cancer cells expressing neoantigens specific to your tumor. This type of genetic modification has not been tested in humans. These modified T-cells are called “NeoTCR-P1” T-cells. NeoTCR-P1 will be given back to you through your vein in one infusion. Unlike standard drugs that are broken down by your body, NeoTCR-P1 is a “living drug.” It is able to proliferate (expand the number and type of stimulated T-cells) extensively in participants. The actual number of cells that expand after infusion will vary from participant to participant. The use of NeoTCR-P1 is experimental and has not been approved by the Food and Drug Administration (FDA) for use outside this study. NeoTCR-P1 is being tested in humans for the first time under this study. Providing your blood for the collection of genetic material to be used in the production of the study drug is not optional in this study.

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

Analysis of Both Sex and Device Specific Factors on Outcomes in Patients With Non-Ischemic Cardiomyopathy

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We invite you to take part in a research study because your doctor has determined that you have non-ischemic cardiomyopathy. This is the weakening of the heart muscle. It is not caused by coronary artery disease or heart attack. This study is for patients who have recently received an ICD or CRT-D implant. Cardiac rhythm devices help the heart function better. They relieve symptoms and treat life threatening arrhythmias (irregular heart beats). The study is being done to better understand ICD or CRT-D implant. These devices are used to prevent sudden cardiac death. They are give to patients who have not yet experienced a cardiac arrest (heart attack) or life threatening arrhythmias (abnormal heart beats). The outcomes will be evaluated to determine if there are differences between the ICD and CRT-D devices. We will also study the differences in effectiveness between men and women.

Other Study
Any, age 18 years or older
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