UC Davis Health Clinical Studies

A Comparison Study of the Experimental Human Acellular Vessel For Dialysis in End-Stage Renal Disease

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This research study is for patients with kidney failure, undergoing hemodialysis with a dialysis catheter. For long term hemodialysis, it's best to create a more permanent and safe route to connect your blood stream to the dialysis machine. There are many ways to do this including surgically implanting a graft (a short piece of tubing). Another option is to surgically connect your artery and vein. This connection is called an autologous arteriovenous fistula or AVF. This study will compare a new investigational graft developed by Humacyte (the Human Acellular Vessel or HAV) with an AVF. This study will compare the ability of the HAV to function as an alternative to AVF for vascular access during hemodialysis.

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

A Study of Experimental Cellular Immunotherapy For Living Donor Kidney Transplants

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The main goal of this research is to determine if the experimental medicine MDR 101 can help kidney transplant patients. The study team will test if a single infusion of MDR 101 will create a state of “tolerance” in the kidney recipient. The study team wants to learn if this treatment will allow patients to minimize anti-rejection medications. They hope patients can stay off these medications for at least 2 years or longer. MDR 101 is processed from blood stem cells from the same person that is the kidney donor. This study will help better understand the effects of this stem cell therapy on kidney transplantation and life after transplant.

Drug study, Phase 3
Any, age 18 to 65 years old

Multicentre, Randomized, Open-Label, Phase III Clinical Trial for Advanced Nasopharyngeal Carcinoma Patients

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This study is a multi-center, randomized, open label, Phase III clinical trial. Drugs used in chemotherapy, such as gemcitabine and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving an infusion of a person's cytotoxic T lymphocytes (CTL) that have been treated in the laboratory may help the body build an effective immune response to kill tumor cells. Giving combination chemotherapy together with laboratory-treated T lymphocytes may kill more tumor cells. This Phase III trial is to assess if combined gemcitabine-carboplatin (GC) followed by adoptive T-cell therapy would improve clinical outcome for patients with advanced nasopharyngeal carcinoma (NPC). It is also the world's first, and largest, Phase 3 T-cell therapy cancer trial ever conducted, and enrollment is ongoing for 330 patients from 29 hospital centers across Asia and the United States. This clinical trial is conducted on the back of a successful Phase 2 NPC trial involving 38 patients at the National Cancer Centre, Singapore. This trial produced the best published 2-year (62.9%), and median overall survival (OS) data (29.9 months) in 35 patients with advanced NPC who received autologous EBV-specific CTL. Kindly see https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3978790/ for the Phase 2 publication titled "Adoptive T-cell Transfer and Chemotherapy in the First line treatment of Metastatic and/or Locally Recurrent Nasopharyngeal Carcinoma".

Biological study, Phase 3
Any, age 21 years or older

Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant

Study looking at stem cell gene therapy to treat patients with HIV and lymphoma

This study is to test the safety of combining stem cell therapy with gene therapy to treat lymphoma. For gene therapy, researchers in a laboratory will add small stretches of DNA called “anti-HIV genes” into your stem cells to make the gene therapy product used in this study. The type of anti-HIV genes and therapy in this study might make your immune cells more resistant to HIV. The goal of the study is to develop an immune system that can actively prevent new immune cells from getting infected with HIV, while the older cells die due to HIV. This new immune system might be able to fight the spread of HIV even without HIV medications. The gene therapy product in combination with your clinically indicated stem cell transplant in this study is considered experimental because it has not been used in human clinical trials and has not been approved by the Food and Drug Administration (FDA) for treatment of HIV. A similar gene therapy product has been used in other human clinical trials with stem cell therapy.

Procedure study, Phase I/II
Any, age 19 to 100 years old