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Research and Outcomes
As one of Southern California's most active and respected research facilities, Cedars-Sinai Medical Center dedicates enormous resources to conducting basic, as well as clinical, research. Our busy research laboratories are staffed by innovative and forward-thinking scientists who devote their time exclusively to discovering new techniques, devices and drugs to add to and improve treatment options for heart disorders of every kind.
Kidney Transplantation Research and Clinical Trials
Because the expertise of its medical professionals is widely acknowledged, Cedars-Sinai is an important hub in the world of kidney transplantation research. Drug companies, scientists from other institutions, technology experts and equipment makers regularly come to our scientific labs to test new protocols and procedures.
Cedars-Sinai is honored to have been awarded two of the five available Controlled Clinical Trials Grants in Kidney Transplantation from the National Institutes of Health (NIH). Each trial, one for pediatric patients and one for adults, studies transplant immunotherapy protocols developed at Cedars-Sinai. The trial is examining the ability of intravenous gamma globulin (IVIG) to lower antibodies that cause kidney transplant rejections. Recently, the Transplant Immunotherapy Program conducted an open-label Phase I/II study using a combination of IVIG & Rituximab to desensitize highly HLA sensitized patients awaiting kidney transplantation. This treatment protocol takes 5 weeks to complete and enables a 80% transplant rate. This approach represents a breakthrough for thousand of patients who await transplantation and was published in New England Journal of Medicine on July 17, 2008. Cedars-Sinai is the only Southern California facility involved in this groundbreaking trial.
In addition, an information analysis project is producing important clues gleaned from a large database of kidney transplant patients. Other projects involve trials of transplant-enhancing drugs.
Rheumatology Clinical Trails and Research
Clinical research and studies are becoming one of the most important ways to advance the treatment of rheumatic diseases. Tests of promising new and innovative clinical studies help find cures, new and more effective therapies and provide information about the genetics of diseases.
As part of our commitment to the health of rheumatic diseases patients, the Division of Rheumatology at Cedars-Sinai has estabalished the Rheumatic Diseases Research Registry. This is a database that contains health information provided by interested individuals who want to make a contribution to the future of medicine. As we begin clinical trials or studies at Cedars-Sinai, we contact appropriate candidates in the registry to see if they would like to participate.
The following clinical studies are underway:
- Genetics of Hand Osteoarthritis Study
- A Comprehensive Model of Severity in Outcomes in Ankylosing Spondylitis
- Studies of the Etiology of Rheumatoid Arthritis
- Improved Diagnosis of Metabolic Diseases in Statin Myopathies
Cardiology Clinical Studies/Trials
One of the important benefits of being a Cedars-Sinai heart patient is that the newest cardiac treatments become available quickly after clinical studies have shown them to be effective. Some of the clinical trials currently underway include:
- The role of apo A-1 Milano in arterial plaque reduction
- Evaluation of the role of anticoagulants in heart failure
- Hormone replacement therapy for women with heart disease
- The effect of supplemental magnesium in patients with heart disease
- Early detection of heart disease through nuclear cardiology
- Techniques for treating restenosis (scar tissue that forms after surgery)
- Methods for improving the effectiveness of drugs after heart transplantation
- Powerful new anti-rejection medications for heart transplant patients
- Radioactive stent therapy o Fetal cardiac correction
Recent Heart Failure Trials
- ADHERE. Systematic study of the treatment and outcomes of patients admitted to the hospital with heart failure.
- BEST. Study of a new beta-blocker in patients with severe heart failure. Study was completed in 2000.
- COMPANION. Study of the use of biventricular pacing (to resynchronize the pumping function of the right and left pumping chambers of the heart) with or without a defibrillator to prevent sudden death in patients with advanced heart failure.
- ESSENTIAL Trial. Study of a new oral medication, enoximone, for patients with advanced heart failure. This medication may improve the pumping function of the heart.
- Nesiritide Cardiac Surgery Study. This is a study of a new intravenous medication, nesiritide, for patients with heart failure after cardiac surgery.
- OVERTURE. Study of a new drug Omapatrilat in patients with advanced heart failure.
- REVIVE. Study of a new intravenous medication, levosimendan, for treatment of patients who are hospitalized with advanced heart failure.
- ValHeFT. Study of new drug Valsartan in patients with heart failure. Study was completed in 2000.
- WATCH. Study of three different types of blood-thinning drugs in patients with advanced heart failure.
Recent Heart Valve-Related Studies
- ACT (Aortic Comparative Trial). In this study, the advantages and drawbacks of two different artificial heart values (a St. Jude Toronto Stentless and an Edwards Pericardial valve) is being compared.
Recent Coronary Artery Disease Trials
- HERS-II. This is a follow-up to the Heart and Estrogen Replacement study and is evaluating the benefits of hormone replacement therapy in women with heart disease.
- TNT. The Treatment to New Targets trial is comparing the benefits of moderate versus high doses of cholesterol-lowering medication in patients with heart disease.
- REVERSAL. In this trial, the benefits of moderate versus aggressive cholesterol-lowering on coronary artery plaque size is being evaluated
Research and Clinical Trials - Advancing Understanding of Pituitary Tumors and Their Treatment
Research is an ongoing process at the Cedars-Sinai Pituitary Center. Scientists at Cedars-Sinai are doing research that expands our knowledge of pituitary tumors -- how they begin, how they grow and how best to treat them.
The Cedars-Sinai Pituitary Center is conducting the following clinical trials:
- The global hypopituitary control and complications study. (IRB #4083. Principal Investigator: Shlomo Melmed, MD)
- A study to compare the safety, efficacy and pharmacokinetic/pharmacodynamic relationship of multiple doses of SOM 230 and doses of open label Sandostatin in acromegalic patients. (IRB #4337. Principal Investigator: Shlomo Melmed, MD)
- A study to explore the natural course of disease for non-functioning microadenomas and non-functioning macroadenomas. (Pro9829. Principal Investigator: Shlomo Melmed) o Effectivness of SOM230 in treating non-functioning pituitary tumors. (IRB # 4291. Principal Investigator: Shlomo Melmed, MD)
- Does surgical debulking of pituitary adenomas improve responsiveness to Octreotide LAR in the treatment of acromegaly: an investigator-initiated study. (IRB #4276. Principal Investigator: Shlomo Melmed)
- A study examining the peri- and post-operative dynamics of the GH/IGF-1 axis in subjects with acromegaly during the first year after surgical resection. (Pro8997. Principal Investigator: John D. Carmichael, MD)
- Laser fluorescence of brain tumors. (IRB #3444. Principal Investigator: Adam Mamelak, MD)
- Prevalence of pituitary incidentaloma in relatives of patients with pituitary adenoma. (IRB #3765. Principal Investigator: Vivien Bonert, MD)
Pulmonary/Critical Care Medicine Clinical Trials
The research department at the Women's Guild Lung Institute has several clinical trials open for patient participation. At Cedars-Sinai, our doctors and researchers study the causes and development of lung cancer in a continuing search for new and better treatments. New anti-cancer drugs and innovative procedures are currently being tested. The Lung Center at Cedars-Sinai is on the forefront of medical technology and offers patients access to the latest clinical trials and investigational studies involving new treatments for diseases of the pulmonary system. Among other national and international studies, The Lung Center is one of the principal centers for the National Institutes of Health study for the treatment of chronic obstructive pulmonary disease (COPD), investigating lung-volume reduction as an effective treatment for end-stage emphysema.
The following is a list of currently open clinical trials and research studies:
- A Study to Evaluate Whether Selenium Yeast Tablet can Prevent New Lung Cancers in People with Surgically Removed Non-Small Cell Lung Cancer as Compared to Patients taking a Placebo Yeast (CALGB) (23 patients) (IRB# 3596) PI: Robert McKenna, Jr., MD
- Clinical Trial of Tarceva® (erlotinib) After Complete Tumor Removal with or without Combination Chemotherapy in Patients with Stage IB-IIIA Non-small Cell Lung Cancer who Have Epidermal Growth Factor Receptor (EGFR) Positive Tumors (OSI Pharmaceuticals Co.) (2 patients) (IRB# 00010207) PI: Ronald Natale, MD
- A Study Comparing the Removal of an Entire Lobe of the Lung (Lobectomy) versus the Removal of a Smaller Portion of the Lobe of the Lung (Sublobar Resection) For Small (< 2 cm) Peripheral Non-Small Cell Lung Cancer Tumors (CALGB) (IRB# Pro00013599) PI: Robert McKenna, Jr., MD
- A Study that Compares Overall Survival in High Risk Patients with Stage I Non-Small Cell Lung Cancer Receiving Either Lung Surgery Followed by Brachytherapy or Lung Surgery Alone (ACOSOG) (IRB# Pro00008305) PI: Robert McKenna, Jr., MD
- The Use of the Intrabronchial Valve (IBV) Valve System under the Humanitarian Device Exemption to Control Prolonged Air Leaks in Patients after Lobectomy, Segmentectomy or Lung Volume Reduction Surgery (IRB# Pro00018920) PI: Robert McKenna, Jr., MD
- A Tissue/Blood/Specimen/Anatomical Part and/or Cell Collection Study (IRB# 3017) PI: Robert McKenna, Jr., MD Collection of Data for the Society of Thoracic Surgeons STS) Database (IRB# 4263) PI: Robert McKenna, Jr., MD
GI Motility Research
Cedars-Sinai's GI Motility Program is conducting leading-edge research in several areas, including irritable bowel syndrome (IBS), small intestinal bacterial overgrowth (SIBO) and motility of the esophagus, stomach and small intestine, as well as studies of movements and controlling mechanisms of the small intestine.
Gastroenterology Research and Clinical Trials
Dr. Mark Pimentel's research interests lie in the field of IBS as it relates to bacteria in the small intestine. Recent findings suggest a very high prevalence of SIBO (a condition in which there is an inappropriate quantity of bacteria in the small intestine). This relationship has resulted in further research demonstrating that the elimination of these bacteria results in the most dramatic improvement in IBS symptoms ever published. As such, the demand for breath testing to rule out SIBO has increased. Follow-up research on this topic has resulted in finding some of the moving problems of the intestine possibly responsible for this development of bacteria. Furthermore, treatments to prevent the recurrence of the bacteria and the IBS symptoms have been developed and have been found to be very effective.
We are currently conducting clinical studies related to SIBO. We are recruiting subjects with IBS, normal subjects and controls. For more information on how to participate in these stu The Pancreatic and Biliary Diseases Program performs research studies to find new treatments and ways of managing pancreatitis and other gastroenterology problems.
Some projects that we are currently working on are our Double Balloon Enteroscopy and Pancreatitis Study and ongoing Wireless Capsule Study.
Patients with pancreatitis or other GI endoscopic problems may have an opportunity to participate in various clinical trials that are being conducted at Cedars-Sinai. The ability to participate in such research depends on the eligibility requirements for the study, the patient's condition and the stage of the trial.