UC Davis Health Clinical Studies

A Study of the Experimental Prevena™ device (Incisional Negative Pressure Wound Therapy) for Soft Tissue Sarcoma Wounds

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Patients with sarcomas (tumor in bone or soft tissue) who receive radiation before surgery have a greater chance of complications in wound healing. This research study will test a wound dressing called Negative Pressure Wound Therapy (NPWT). NPWT is a wound sponge attached to a gentle suction device. It is more effective at preventing infection of the surgical wound than standard dry gauze wound dressing. The Prevena™ device (NPWT) is FDA approved for use on incisions. This will be considered the investigational dressing. The NPWT device is a foam sponge that is placed over the incision after surgery, and provides a low pressure gentle suction on the wound. It is sealed with an adhesive dressing. The traditional standard dry gauze dressing will be considered the control dressing for this study

Device study
Any, age 18 years or older

A Long-Term Safety and Tolerability Study of Experimental Givinostat in Duchenne Muscular Dystrophy

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This study will test the long-term safety and effectiveness of the experimental medicine Givinostat. It will be given to patients with Duchenne Muscular Dystrophy (DMD). This long-term study is for patients who have already participated in a study with Givinostat. It provides the opportunity for them to continue treatment. This study is for patients with Duchenne Muscular Dystrophy currently taking experimental Givinostat.

Drug study, Phase [2, 3]
Male, age 7 years or older

A Study of the Experimental Medicine Edasalonexent in Boys With Duchenne Muscular Dystrophy

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This research study will test the effectiveness and safety of experimental edasalonexent. It will be studied in patients with Duchenne Muscular Dystrophy (DMD). An experimental drug is one that has not been approved by the FDA to treat this condition. A mutation (error) in the gene for dystrophin causes DMD. In DMD, dystrophin is not present in the muscle cells. Dystrophin is a protein that helps muscle cells keep their structure. Without dystrophin, muscle contractions damage the membrane around individual muscle cells. This results in cellular degeneration (decline) and inflammation (swelling). It also prevents cellular regeneration (new cells). Over time, the cycle will cause the muscle to be replaced with fibrotic tissue (scar tissue) and fat.

Drug study, Phase 3
Male, age 4 to 7 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 Experimental Neuro-Spinal Scaffold™ Device for Complete Thoracic AIS A Spinal Cord Injury

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The purpose of this study is to test the safety and benefit of a new medical device. This device is implanted into the injured spinal cord for a recent spinal cord injury. The procedure to implant the medical device may be added to the usual, standard treatment for spinal cord injury. The study doctor will attempt to perform your surgery as soon as possible. The medical device is experimental and is not approved by the FDA. There is no evidence that the medical device will be of any benefit to you. However, the study will look at whether the new medical device helps improve the medical condition of patients with recent spinal cord injuries.

Device study
Any, age 16 to 70 years old

A Randomized Trial Comparing Monocryl(absorbable) vs. Nylon (traditional) Suture Closure in Carpal Tunnel Surgery

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This research study hopes to determine if there is a significant difference in using two different types of sutures (stitches): - subcuticular (under the skin) Monocryl (absorbable) vs - traditional Nylon sutures (stitches) These sutures will be used after open carpal tunnel decompression surgery. Both types of suture are commonly used in clinical practice. There is no objective data about which is “better”.

Procedure study
Any, age 18 years or older

A Study of the Experimental Medicine Idebenone for Duchenne Muscular Dystrophy (DMD)

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This study is for patients with DMD, who completed the SIDEROS study. The study doctor will determine if you are eligible for this SIDEROS-Extension study. In this study, a series of physical and laboratory tests will be done. This will check the safety and effectiveness of experimental idebenone. Any side effects will be checked by physical examination, including tests on the heart and by laboratory tests on blood and urine.

Drug study, Phase 3
Male, age 11 years or older

A Study of Experimental PLX-PAD Cells for the Treatment of Muscle Injury After Arthroplasty for Hip Fracture

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This study hopes to learn if the experimental medicine PLX-PAD is effective and safe to treat muscle injury after hip surgery. It will be compared to placebo (a drug that looks like the study drug but has no effect). During surgery after hip fracture, further muscle injury usually occurs. This muscle injury is in addition to the initial muscle injury caused by the hip fracture itself. Further muscle injury may cause loss of muscle mass and strength. It can lead to reduced mobility after recovering from the hip surgery. There is currently no treatment to improve the recovery of the muscle after a hip surgery. PLX-PAD is a cellular therapy. This means that it contains living cells which are injected into the patient’s muscles. These cells come from a human placenta. The cells are collected during a planned cesarean section from healthy female volunteers who donated it. All donors of the placenta complete a comprehensive questionnaire. It asks about 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. Cells in PLX-PAD respond to stress signals from tissues that have been damaged. Although it is not proven, it is thought that PLX-PAD cells injected into the injured muscle during the surgery can improve muscle function after surgery. This improves recovery after surgery for hip fracture. The placebo contains just the fluid with dimethyl sulfoxide (DMSO), human serum albumin (human blood protein) and PlasmaLyte (salts solution), but does not contain the PLX-PAD cells.

Drug study, Phase 3
Any, age 60 to 90 years old

A Study of the Effectiveness and Safety of Oxiplex® Gel to Reduce Pain and Symptoms Following Lumbar Disc Surgery

Please consider joining this clinical research study if you are having surgery for a herniated lumbar disc.

This study will examine the safety and effectiveness of an experimental device called Oxiplex. Oxiplex gel is not yet approved in the U.S. by the FDA. Oxiplex may help prevent some of the side effects that can occur after lower back spine surgery. This includes leg pain not resolved with surgery, back pain, and neurological symptoms such as weakness and numbness. Oxiplex gel is a sterile, bioresorbable (dissolves and absorbs into the body) product. The gel does not require removal after surgery and clears from the body. Oxiplex may improve post-surgical leg and back pain by providing a physical barrier for the nerves around your surgical site. It is applied during the lumbar spine surgery to coat the sensory nerves. This barrier isolates the nerves from tissues and fluid that may cause inflammation in that area.

Device study
Any, age 22 to 70 years old
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