Clinical studies roundup: Scientists create functioning intestinal tissue from stem cells

Here’s a roundup of recent clinical trial and scientific study news:

• Scientists create functioning intestinal tissue from stem cells
  For the first time, scientists have created functioning human intestinal tissue in the laboratory from pluripotent stem cells. In a study posted online Dec. 12 by Nature, scientists from Cincinnati Children’s Hospital Medical Center say their findings will open the door to unprecedented studies of human intestinal development, function and disease. The process is also a significant step toward generating intestinal tissue for transplantation, researchers say.
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• Heart disease and stroke death rates declines over last 10 years
  The death rate from cardiovascular disease in the United States declined 28 percent since the late 1990s, but heart disease and stroke still account for one-third of all deaths, according to a new study in the American Heart Association journal Circulation, reports HealthDay.
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• Benefits of pressure cycling technology cited in recent cancer and heart disease studies
  Pressure BioSciences Inc. (NSDQ:PBIO) announced that significant benefits were reported when the company’s, patented pressure cycling technology (PCT) platform was used in either the fixation or extraction of proteins from formalin-fixed, paraffin-embedded (FFPE) tissue samples in four recent cancer and heart disease studies.
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• Vitamin K antagonists use for treatment of atrial fibrillation driven by availability of an oral formulation, cost and widespread inclusion on guidelines and formularies
  Arlington Medical Resources (AMR), a provider of market intelligence for the pharmaceutical and diagnostic imaging industries, finds that, in the treatment of atrial fibrillation, surveyed European cardiologists indicate that use of vitamin K antagonists, as a class, is primarily driven by the availability of an oral formulation, overall low cost and widespread inclusion on European medical society guidelines and hospital formularies. Vitamin K antagonists and low molecular weight heparins are the most commonly used anticoagulants across physician specialties in Europe.
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• Canadian heart valve study provides evidence of On-X heart valve superior performance
  On-X Life Technologies Inc. (On-X LTI), announced the publication of results of a large, prospective multi-center Canadian trial with the On-X Prosthetic Heart Valve in the November issue of The Journal of Thoracic and Cardiovascular Surgery. According to the results of the report, “The On-X mechanical prosthesis provides favorable intermediate-term results with regard to major thromboembolism, hemorrhage and composites of valve-related complications.”
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• Beaumont hospital launches atudy of single-dose radiation treatment for prostate cancer
  Beaumont Hospital radiation oncologists launched a research study to treat men with low to intermediate risk prostate cancer with a single dose of radiation. The study, approved by Beaumont’s Human Investigation Committee, builds upon 18 years of past research by Oakland University William Beaumont School of Medicine professor Dr. Alvaro Martinez and other Beaumont radiation oncologists on ways to kill cancer cells through powerful, targeted, short-term radiation treatment.
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• Economic evaluation of FAME trial confirms using FFR in treatment of coronary artery disease is cost-effective
  St. Jude Medical Inc. (NYSE:STJ), a global medical device company, announced the publication of results from an economic evaluation of the landmark FAME (Fractional Flow Reserve (FFR) vs. Angiography in Multivessel Evaluation) trial, which confirmed FFR-guided percutaneous coronary intervention (PCI) in patients with multivessel coronary artery disease improves patient outcomes and offers cost-saving benefits to the U.S. healthcare system.
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• Study shows BSGI/MBI contributes significantly to patient management with its ability to detect breast cancer in difficult to diagnose patients
  Dr. Barbara Ward and others of Weinstein Imaging determined that Breast-Specific Gamma Imaging/Molecular Breast Imaging (BSGI/MBI) provides additional information when conventional imaging is indeterminate and greater confidence is required to improve diagnostic accuracy. The data from the retrospective study demonstrated that BSGI contributed significantly to patient management by detecting cancer in 7 of the 73 patients (9 percent), and was presented last week at the San Antonio Breast Cancer Symposium.
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• Sequenom announces publication acceptance of manuscript from Trisomy 21 R&D verification study
  Sequenom Inc. (NSDQ:SQNM) today announced the acceptance of a manuscript describing results from the R&D “locked-assay” verification study conducted by the company’s wholly-owned subsidiary, Sequenom Center for Molecular Medicine.
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• deCODE discovers genetic markers that improve the power of PSA testing for detecting prostate cancer
  
  Scientists from deCODE genetics and academic colleagues from Iceland, the U.K., U.S., Netherlands, Spain and Romania reported the discovery of a set of single-letter variations in the sequence of the human genome (SNPs) that impact individual baseline levels of prostate specific antigen, or PSA. A prostate biopsy is routinely recommended for men with PSA above a certain threshold. However, PSA levels can rise for reasons unrelated to prostate cancer and baseline healthy levels vary substantially between individuals, resulting in many men without cancer being biopsied while cancer in others is not detected. The paper published today demonstrates that analysis of four SNPs can be used to derive a personalized PSA threshold that more accurately identifies those men who are more likely to have a positive biopsy and for whom one should therefore be recommended.
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• Study shows how flu infections may prevent asthma
  In a paper that suggests a new strategy to prevent asthma, scientists at Children’s Hospital Boston and their colleagues report that the influenza virus infection in young mice protected the mice as adults against the development of allergic asthma. The same protective effect was achieved by treating young mice with compound isolated from the bacterium Helicobacter pylori (H. pylori), a bacterium that colonizes the stomach and is best known for causing ulcers and increasing the risk of gastric cancers.
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• New clinical study presented at the American Association of Respiratory Care finds Masimo Rainbow acoustic monitoring accurate for respiration rate assessment
  
  Masimo (NSDQ:MASI) announced today that a new clinical study demonstrating the accuracy of its latest medical technology breakthrough—Rainbow Acoustic Monitoring™—was presented last week at the American Association of Respiratory Care’s (AARC) 56th Annual International Respiratory Congress in Las Vegas. The largest gathering of respiratory care clinicians in the world, the AARC Annual Meeting provides an important platform for previewing the latest in medical developments and clinical research to respiratory care thought-leaders.
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• Clinical investigators address confusion over study of patent foramen ovale in stroke patients
  
  W. L. Gore & Associates released the following statement from its REDUCE Clinical Study Principal Investigators on behalf of the Gore REDUCE Clinical Study Steering Committee in response to the recent CLOSURE I results presentation. The Gore REDUCE Clinical Study is a prospective, randomized, multi-center, multi-national trial designed to demonstrate safety and effectiveness of the GORE HELEX Septal Occluder for patent foramen ovale closure in patients with history of cryptogenic stroke or imaging-confirmed Transient Ischemic Attack (TIA). The unique study includes up to fifty investigational sites in the U.S. and Europe.
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• Stimatix GI reports meeting primary endpoints in pre-clinical studies demonstrating effectiveness of the AOS-C1000(TM) colostomy management system
  
  Stimatix GI reported that the AOS-C1000(TM), a unique colostomy management device, met primary and secondary endpoints in pre-clinical in-vivo animal studies. The study was conducted under the direction of Dr. Ron Greenberg, Senior Surgeon, Department of Surgery, Sourasky Medical Center, Tel Aviv Israel. Primary endpoints of repeatable stoma sealing for continence control as well as secondary endpoints regarding tissue pathology and survival were met confirming the AOS-C1000(TM) as capable of enabling repeatable colostomy site (stoma) sealing for continence control.
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• First patient enrolled in multi-center clinical trial of the CorMatrix ECM for pericardial closure to reduce the incidence of new onset postoperative atrial fibrillation
  CorMatrix Cardiovascular Inc., an Atlanta-based company dedicated to developing and delivering extracellular matrix (ECM) biomaterial devices that harness the body’s innate ability to repair damaged cardiovascular tissue, announced that Franciscan Alliance/St. Francis Heart Center in Indianapolis, Ind. is the first site to enroll a patient in the multi-center clinical trial of the CorMatrix ECM for Pericardial Closure to reduce the incidence of new onset postoperative atrial fibrillation.
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