Santa Clara Valley Medical Center
Santa Clara Valley Medical Center
News Article | May 11, 2017
"These new follow-up results based on MRI scans are very encouraging, and strongly suggest that AST-OPC1 cells have engrafted in these patients post-implantation and have the potential to prevent lesion cavity formation, possibly reducing long-term spinal cord tissue deterioration after spinal cord injury," said Dr. Edward Wirth, Chief Medical Officer of Asterias. "Moreover, these new results add to the overall body of data supporting AST-OPC1's safety, and are consistent with safety data from our previous Phase 1 study in thoracic spinal cord injury and our extensive preclinical studies in more than 3,000 animals." Under the study protocol, patients are monitored by MRI scans at regular intervals over 12 months in order to assess status of the injection site and surrounding tissues. The Company will discuss the MRI data in more detail on its first quarter 2017 conference call and webcast on May 11, 2017 at 4:30 p.m. Eastern / 1:30 p.m Pacific. For both "listen-only" participants and those participants who wish to take part in the question-and-answer session, the call can be accessed by dialing 800-533-7619 (U.S./Canada) or 785-830-1923 (international) five minutes prior to the start of the call and providing the Conference ID 7610291. To access the live webcast, go to http://asteriasbiotherapeutics.com/inv_events_presentations.php. The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with sub-acute, C-5 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may retain some minimal sensory function below their injury site. AST-OPC1 is being administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product. The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1. Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com). AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site. In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. They also received low levels of immunosuppression for the next 60 days. Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with AST-OPC1. No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all patients. In four of the five patients, serial MRI scans indicated that reduced spinal cord cavitation may have occurred. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries, which represents the first targeted population for registration trials. Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company's proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company's research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com. Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias' filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-mri-data-from-asterias-ongoing-scistar-clinical-study-indicates-ast-opc1-cells-prevent-formation-of-damaging-lesion-cavities-in-patients-suffering-severe-spinal-cord-injury-300455768.html
News Article | May 10, 2017
Development Provides Privately Owned Medical/Dental Suites for Medical Professionals, Eliminating the Need for Landlords Venture Corporation, the nation’s pioneer in commercial condominiums, has announced the opening of Moorpark Professional Center at 2211 Moorpark Avenue in San Jose. The building includes 16 medical properties available for private ownership and ranging in size from 992 to 3,185 square feet. The building is constructed over subterranean parking exclusively assigned to the building’s medical professionals. It is located at the confluence of Interstate 880 and 280, directly across Moorpark Avenue from Santa Clara Valley Medical Center and a short drive to numerous hospitals and medical centers. The medical suites at Moorpark Professional Center are available for purchase by medical professionals who want the benefits of ownership — equity build-up every month, growth in value, tax write-offs and no more annual rent increases. Unlike other real estate acquisitions, the medical suites in this building are available with 100% financing in place; no down payment is required. “Our mission is to give physicians and dentists the opportunity to capture the financial advantages of ownership and say farewell to their landlords,” said Robert Eves, Venture Corporation’s president. “The monthly cost of ownership is equal to or less than the cost of renting the same medical suite. Why hand all the profits to the landlord?” One of the unusual features of Moorpark Professional Center is that it is equipped with a mahogany Board Room with a large-screen TV and internet access. A doctor can take his or her patient into the Board Room for a private consultation and review of medical conditions via Internet on the big screen. Rick Bell, head of sales at the project, reported: “Physicians love to take a mid-day sandwich break in the Board Room and catch up on the world news. Some of the doctors plan end-of-the-day gatherings with building friends to share a glass of wine or celebrate birthdays. The Board Room is equipped with temperature-controlled wine coolers with private bottle slots for each suite owner’s collection.” Venture Corporation’s commercial condominium properties have been built throughout much of California, with many more in Oregon, Washington and Nevada. “Some of our centers have been purely medical/dental buildings,” reported Venture’s president, Eves, “and they were quickly purchased by medical professionals who rarely move, wanted to avoid annual rent increases, and were eager to receive the equity growth that would have gone to their landlords. That explains why medical office buildings held their values far better than other investments during the Great Recession.” San Jose is the best market in the entire nation for medical office buildings, according to John Smelter, First Vice President in charge of medical office buildings at international brokerage Marcus & Millichap. Smelter recently reported that San Jose, California, has the highest medical office building occupancy in the entire nation at 97.5%. No other real estate investment group can match this performance. Some of the suites at Moorpark Professional Center are leased and are being offered to private investors. Sales chief Rick Bell reported that several large suites have nearly four years remaining on their leases and long-term extension options at market rates. Rick Bell said, “These are ideal investments for smaller investors. The tenants don’t move and the property owner’s association handles all management issues. The properties are headache-free, and the returns are good and increase every year.” Moorpark Professional Center is expected to sell out by year end, according to Venture’s development team. For more information, call Rick Bell at (408) 829-4853, Robert Eves at (415) 464-2000 or visit the building’s website at www.MoorparkPC.com. High-resolution photos available.
Brown C.H.,Santa Clara Valley Medical Center
Advances in Intelligent Systems and Computing | Year: 2017
During the past two decades in health care, increasing numbers of preventable hospital deaths and medical errors, an explosion of technologies, pharmaceuticals, and diagnostic and therapeutic techniques, and rising costs have resulted in a shift in focus away from “one doctor, one patient” to the systems and processes that support care delivery. While leaders in health care have begun to recognize the contribution of engineering tools and principles in improving health care safety and quality, integration of these techniques and the engagement of engineers has not been fully realized. Creating an infrastructure that promotes a collaborative foundation begins in the academic setting. This article describes a three-pronged approach to integration that will ultimately improve results, efficiency, efficacy, and clinical and operational outcomes in health care facilities. © Springer International Publishing Switzerland 2017.
Szumowsk J.D.,University of Washington |
Szumowsk J.D.,Santa Clara Valley Medical Center |
Lynch J.B.,University of Washington
Drug Design, Development and Therapy | Year: 2015
New approaches to the treatment of multidrug-resistant and extensively drug-resistant tuberculosis (TB) are badly needed. Not only is the success rate of current treatment regimens suboptimal but existing regimens require multiple drugs and lengthy courses and may lead to signifcant toxicities. The treatment landscape is beginning to shift, however, with the recent approvals of the new TB drugs bedaquiline and delamanid. Delamanid, a dihydro-imidazooxazole, has been shown to have excellent activity against Mycobacterium tuberculosis in both in vitro and in murine TB models. It has also recently been reported to improve rates of sputum culture conversion in patients with multidrug-resistant TB when added to an optimized background regimen. Although generally well tolerated, delamanid has been associated with QT prolongation, which may be of particular clinical concern when paired with other TB drugs that may also have this effect, most notably the fuoroquinolones. Ongoing studies will help to clarify delamanid’s role in the treatment of drug-resistant TB. © 2015 Szumowski and Lynch.
Coon E.R.,University of Utah |
Quinonez R.A.,Baylor College of Medicine |
Moyer V.A.,American Board of Pediatrics |
Schroeder A.R.,Santa Clara Valley Medical Center
Pediatrics | Year: 2014
Overdiagnosis occurs when a true abnormality is discovered, but detection of that abnormality does not benefit the patient. It should be distinguished from misdiagnosis, in which the diagnosis is inaccurate, and it is not synonymous with overtreatment or overuse, in which excess medication or procedures are provided to patients for both correct and incorrect diagnoses. Overdiagnosis for adult conditions has gained a great deal of recognition over the last few years, led by realizations that certain screening initiatives, such as those for breast and prostate cancer, may be harming the very people they were designed to protect. In the fall of 2014, the second international Preventing Overdiagnosis Conference will be held, and the British Medical Journal will produce an overdiagnosis-themed journal issue. However, overdiagnosis in children has been less well described. This special article seeks to raise awareness of the possibility of overdiagnosis in pediatrics, suggesting that overdiagnosis may affect commonly diagnosed conditions such as attention-deficit/hyperactivity disorder, bacteremia, food allergy, hyperbilirubinemia, obstructive sleep apnea, and urinary tract infection. Through these and other examples, we discuss why overdiagnosis occurs and how it may be harming children. Additionally, we consider research and education strategies, with the goal to better elucidate pediatric overdiagnosis and mitigate its influence. Copyright © 2014 by the American Academy of Pediatrics.
News Article | March 2, 2017
In June 2016, on the day before his high school graduation, nineteen-year-old Jake Javier suffered a terrible diving accident that left him paralyzed. The incident was covered widely across Bay Area news media and residents quickly mobilized to support Jake and his family. In the March issue of Diablo Magazine, Senior Editor Pete Crooks revisits the story of Jake’s bravery and trailblazing medical care. Crooks caught up with Jake and his parents to discuss life after the accident and explore the life-saving treatments he received at John Muir’s Walnut Creek Medical Center and Santa Clara Valley Medical Center. As part of his therapy, Jake participated in a groundbreaking stem cell procedure by the California Institute for Regenerative Medicine in Oakland. Jake was one of five people in the world to receive an injection of 10 million embryonic stem cells. “This story needed to be revisited.” says Crooks. “Diablo magazine is the town square of the East Bay, and we needed to give Jake’s story time to develop and really share how brave and pioneering he is.” The article details the days and months following the accident and how the community rallied around Jake. Friends, classmates and even strangers joined forces to organize fundraising drives and provide support for the Javier family. To read about the incredible support from the community, Jake’s plans for a future as a college freshman, and view a link to support Jake through the JaviStrong54 Foundation, visit diablomag.com. About Diablo Magazine Covering topics ranging from travel, culture, and personalities to entertainment, recreation, and food, Diablo magazine is written specifically for the San Francisco East Bay market—from Central Contra Costa, into the Oakland and Berkeley hills, and throughout the Tri-Valley. With locally driven editorial content, beautiful photography, and resource listings, Diablo is a unique celebration of the San Francisco East Bay. Published since 1979, Diablo has been recognized for its editorial and design with numerous awards, including previous Maggie Awards for Best Overall Publication and Best Regional and State Magazine in the consumer category. About Diablo Publications For 35 years, Diablo Publications has been creating award-winning publications, including Diablo magazine, Napa Sonoma magazine, Diablo Weddings, the Oakland Visitors' Guide, Diablo Arts, and the Tri-Valley California Visitors Guide. Covering travel, theater, lifestyle, and home design, Diablo Publications celebrates the people, places, and pleasures of the East Bay and North Bay. Diablo Publications’ custom content division, Diablo Custom Publishing (DCP), provides complete print and online marketing communications and customer publishing services for corporate clients nationwide. For more information, visit diablomag.com or dcpubs.com. Diablo Publications is an employee-owned company.
Chetty S.,Stanford University |
Garabedian M.J.,Santa Clara Valley Medical Center |
Norton M.E.,Stanford University
Prenatal Diagnosis | Year: 2013
Objective: The aim of this study was to investigate how the introduction of noninvasive prenatal testing (NIPT) impacted women's testing choices following a positive prenatal screening (PNS) result. Methods: Beginning in March 2012, women referred to our Prenatal Diagnosis Center following a positive PNS result were offered NIPT or invasive prenatal diagnosis. Rates of invasive testing and declining follow-up were compared with testing decisions the prior year. Differences were compared using t-test and chi-square. Multivariable logistic regression was performed to identify predictors of test choice. Results: Between March 2012 and February 2013, 398 screen positive women were seen: 156 (39.2%) underwent invasive testing, 157 (39.4%) had NIPT and 84 (21.1%) declined further testing. In the prior year, 638 screen positive patients were seen: 301 (47.2%) had invasive testing and 337 (52.8%) declined. The rate of invasive testing declined significantly (p=0.012). Moreover, fewer women declined follow-up testing after introduction of NIPT, 21.2% versus 52.8%, p≤0.001. Race/ethnicity and timing of results (first versus second trimester) were predictors of testing choices; payer and maternal age were not. Conclusion: The introduction of NIPT resulted in a significant decrease in invasive diagnostic testing. Additionally, fewer women declined further testing when NIPT was available. © 2013 John Wiley & Sons, Ltd.
Schroeder A.R.,Santa Clara Valley Medical Center |
Mansbach J.M.,Harvard University
Current Opinion in Pediatrics | Year: 2014
PURPOSE OF REVIEW: Bronchiolitis is a common condition in children less than 2years of age and is a leading cause of infant hospitalization. Although there is significant variability in testing and treatment of children with bronchiolitis, diagnostic testing rarely improves care, and no currently available pharmacologic options have been proven to provide meaningful benefits or improve outcomes. RECENT FINDINGS: Beta-agonists continue to be used frequently despite evidence that they do not reduce hospital admissions or length of stay. In general, therapies initially considered promising were subsequently proven ineffective, a pattern seen in studies on corticosteroids, and more recently with nebulized racemic epinephrine and hypertonic saline. Recent research has improved our understanding of the viral epidemiology of bronchiolitis, with increasing recognition of viruses other than respiratory syncytial virus and better awareness of the role of viral coinfections. How these findings will translate into improved outcomes remains uncertain. SUMMARY: Much of the emphasis of the last few decades of bronchiolitis clinical care and research has centered on the identification and testing of novel therapies. Future quality improvement efforts should focus more on the limitation of unnecessary testing and treatments. Future research should include identification of subgroups of children with bronchiolitis that may benefit from focused clinical interventions. © 2014 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Hart N.D.,Santa Clara Valley Medical Center
The journal of knee surgery | Year: 2012
Quadriceps rupture off the patella is traditionally repaired by a transosseous tunnel technique, although a single-row suture anchor repair has recently been described. This study biomechanically tested a new transosseous equivalent (TE) double-row suture anchor technique compared with the transosseous repair for quadriceps repair. After simulated quadriceps-patella avulsion in 10 matched cadaveric knees, repairs were completed by either a three tunnel transosseous (TT = 5) or a TE suture anchor (TE = 5) technique. Double-row repairs were done using two 5.5 Bio-Corkscrew FT (fully threaded) (Arthrex, Inc., Naples, FL, USA) and two 3.5 Bio-PushLock anchors (Arthrex, Inc., Naples, FL, USA) with all 10 repairs done with #2 FiberWire suture (Arthrex, Inc., Naples, FL). Cyclic testing from 50 to 250 N for 250 cycles and pull to failure load (1 mm/s) were undertaken. Gap formation and ultimate tensile load (N) were recorded and stiffness data (N/mm) were calculated. Statistical analysis was performed using a Mann-Whitney U test and survival characteristics examined with Kaplan-Meier test. No significant difference was found between the TE and TT groups in stiffness (TE = 134 +/- 15 N/mm, TT = 132 +/- 26 N/mm, p = 0.28). The TE group had significantly less ultimate tensile load (N) compared with the TT group (TE = 447 +/- 86 N, TT = 591 +/- 84 N, p = 0.04), with all failures occurring at the suture eyelets. Although both quadriceps repairs were sufficiently strong, the transosseous repairs were stronger than the TE suture anchor repairs. The repair stiffness and gap formation were similar between the groups.
News Article | February 15, 2017
Syndicate Group is proud to announce that it will be exhibiting at HIMSS 2017 to be held in Orlando from February 19th to 23rd, 2017. Syndicate’s goal is to contribute to positive patient identification & patient safety and improve inventory tracking through its range of innovative healthcare products. As an exhibitor, Syndicate Group will be showcasing their range of Laser Printable & Direct Thermal Wristbands and RFID Wristbands for Patient Identification, and RFID Labels for Inventory Tracking. Patient safety is a top priority in every hospital. Failure to correctly identify patients leads to patients being given incorrect treatment, surgical procedure or medication leading to serious medical complications. Syndicate Group's ultimoID® MED Direct Thermal and RFID Wristbands solve this problem as they provide secure and positive patient identification through the use of barcode and RFID technology thereby helping healthcare practitioners in achieving the “five rights of medical administration”. Another challenge which hospitals face is due to high-value equipment getting lost or stolen which costs them millions of dollars each year and affects staff productivity. For example, in 2015, the Santa Clara Valley Medical Center in San Jose, CA, reported 383 items missing from 2010 to 2014, valued at more than $11 million. There are many similar incidents reported each year. Syndicate Group’s range of RFID Labels for Asset Tracking help healthcare practitioners gain better visibility, increase staff productivity and also ensure patient safety by: To learn more about Syndicate Group, visit booth # 4493 during HIMSS ’17. Syndicate Group is a leader in the access control, track & trace and authentication sectors catering to a diverse client base in healthcare, manufacturing, logistics, amusement and other industries. With over 30 years of experience, it is driven by passion for its products and aims to turn customers into partners. Visit us on: http://www.syndicategroup.net