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Serruys P.W.,Erasmus Medical Center | Onuma Y.,Erasmus Medical Center | Garg S.,Erasmus Medical Center | Vranckx P.,Hartcentrum | And 11 more authors.
Journal of the American College of Cardiology | Year: 2010

Objectives: The purpose of this study is to compare the 5-year clinical outcomes, safety, and efficacy of sirolimus-eluting stents (SES) in the ARTS II (Arterial Revascularization Therapies Study II) with the outcomes of coronary artery bypass graft (CABG) and bare-metal stenting (BMS) from the ARTS I. Background: The long-term outcomes after SES implantation in patients with multivessel disease remains to be established. Methods: The ARTS I was a randomized trial of 1,205 patients with multivessel disease comparing CABG and BMS. The ARTS II study was a nonrandomized trial with the Cypher sirolimus-eluting stent (Cordis, a Johnson & Johnson Company, Warren, New Jersey), applying the same inclusion and exclusion criteria, end points, and protocol definitions. The ARTS II trial enrolled 607 patients, with an attempt to enroll at least one-third of patients with 3-vessel disease. Results: At 5-year, the death/stroke/myocardial infarction event-free survival rate was 87.1% in ARTS II SES, versus 86.0% (p = 0.1) and 81.9% (p = 0.007) in ARTS I CABG and BMS cohorts, respectively. The 5-year major adverse cardiac and cerebrovascular event (MACCE) rate in ARTS II (27.5%) was significantly higher than ARTS I CABG (21.1%, p = 0.02), and lower than in ARTS I BMS (41.5%, p < 0.001). The cumulative incidence of definite stent thrombosis was 3.8%. Thirty-two percent (56 of 176) of major adverse cardiac events (MACE) at 5 years were related to possible, probable, or definite stent thrombosis. Conclusions: At 5 years, SES had a safety record comparable to CABG and superior to BMS, and a MACCE rate that was higher than in patients treated with CABG, and lower than in those treated with BMS. Approximately one-third of the events seen with SES could be prevented through the elimination of early, late, and very late stent thrombosis. © 2010 American College of Cardiology Foundation.


Oueslati A.,Ecole Polytechnique Federale de Lausanne | Oueslati A.,University of Québec | Lovisa B.,Ecole Polytechnique Federale de Lausanne | Lovisa B.,A Johnson And Johnson Company | And 6 more authors.
PLoS ONE | Year: 2015

Converging lines of evidence indicate that near-infrared light treatment, also known as photobiomodulation (PBM), may exert beneficial effects and protect against cellular toxicity and degeneration in several animal models of human pathologies, including neurodegenerative disorders. In the present study, we report that chronic PMB treatment mitigates dopaminergic loss induced by unilateral overexpression of human á-synuclein (á-syn) in the substantia nigra of an AAV-based rat genetic model of Parkinson's disease (PD). In this model, daily exposure of both sides of the rat's head to 808-nm near-infrared light for 28 consecutive days alleviated á-syn-induced motor impairment, as assessed using the cylinder test. This treatment also significantly reduced dopaminergic neuronal loss in the injected substantia nigra and preserved dopaminergic fibers in the ipsilateral striatum. These beneficial effects were sustained for at least 6 weeks after discontinuing the treatment. Together, our data point to PBM as a possible therapeutic strategy for the treatment of PD and other related synucleinopathies. © 2015 Oueslati et al This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.


Xia C.-Q.,University of Florida | Chernatynskaya A.,University of Florida | Lai Y.,University of Florida | Campbell K.A.,a Johnson and Johnson Company | Clare-Salzler M.J.,University of Florida
Clinical Immunology | Year: 2010

In our previous studies, we demonstrated that infusion of apoptotic cells significantly prevented type 1 diabetes (T1D) in non-obese diabetic (NOD) mice. Extracorporeal photopheresis (ECP) is an apoptotic cell-based therapy used clinically for immune-mediated disorders. In this study, we examined the effect that intravenous delivery of apoptotic cells (ECP-treated) has in the prevention of T1D in NOD mice. We discovered that five weekly injections of ECP-treated NOD spleen cells, beginning at 8 weeks of age, significantly delayed diabetes onset. Furthermore, cell dose studies demonstrated that low dose ECP-treated spleen cells (2 × 105 cells/injection/mouse) had similar protective effects as compared to high dose (5 × 106 cells/injection). In contrast to ECP-treated cells alone, ECP-treated cells combined with β cell antigens appeared to improve the protective effect as shown by the marked reduction in insulitis in the islets. Delivery of ECP-treated spleen cells or ECP-treated spleen cells plus β cell antigen increased Foxp3+ Tregs, and β cell antigen-specific T cell proliferation was significantly suppressed in vivo in these two groups. In addition, we found that ECP-treated cells did not induce global immunosuppression or autoimmunity against nuclear antigens. In conclusion, ECP-treated cells provide a safe and effective approach in T1D prevention, suggesting that clinical ECP has great potential for managing human T1D. © 2010 Elsevier Inc. All rights reserved.


Shellock F.G.,University of Southern California | Bedwinek A.,a Johnson and Johnson Company | Oliver-Allen M.,Loyola Marymount University | Wilson S.F.,a Johnson and Johnson Company
American Journal of Roentgenology | Year: 2011

OBJECTIVE. A newly developed CSF shunt valve that incorporates a magnetically adjustable mechanism designed to resist unintended setting changes was evaluated for problems during 3-T MRI. MATERIALS AND METHODS. Standardized protocols were used to assess magnetic field interactions, MRI-related heating, artifacts, and functional changes related to multiple exposures and various MRI conditions in nine different samples at 3 T. RESULTS. The magnetic field interactions were not excessive. MRI-related heating, which was studied at a relatively high, MRI system-reported whole body-averaged specific absorption rate (2.9 W/kg), was at a level that should not pose a hazard to a patient. Although artifacts were large in relation to the dimensions of this programmable CSF shunt valve, the results were consistent with similar devices containing permanent magnets. Multiple exposures and various MRI conditions at 3 T did not damage or affect the functional aspects of the devices, and no unintentional changes to the valve setting were observed. CONCLUSION. In consideration of the test results, this new programmable CSF shunt valve is not adversely affected by the 3-T MRI environment and is acceptable for a patient undergoing MRI at 3 T or less when specific guidelines are followed, including verifying the valve setting according to manufacturer recommendations immediately after the MRI procedure. © American Roentgen Ray Society.


Muench T.R.,ETHICON,Inc. | Kong W.,LLC a Johnson and Johnson Company | Harmon A.M.,LLC a Johnson and Johnson Company
Biomaterials | Year: 2010

Many surgical methods and hemostatic agents can be used to achieve and maintain hemostasis in surgical fields. Numerous clinical situations exist where current treatment modalities are neither effective nor practical. Assessment of new hemostats primarily targets efficacy. However, the biocompatibility and healing properties associated with hemostats are crucial for regulatory approval and product acceptance. Standard biocompatibility and healing studies may not be appropriate for hemostats containing active biologics. Liver defects in NTac:NIH-Whn (athymic) and Sprague Dawley ® ™ Outbred (immunocompetent) rats were treated with Fibrin Pad (absorbable matrix containing human-derived biologics) or the matrix only. Defects were evaluated at 14 and 28 days post-implantation. As expected, Fibrin Pad in immunocompetent rats induced a cellular immune response. Unexpectedly, biologically significant decreases in healing, material absorption, and local fibrin degradation were also present. Evaluation of Fibrin Pad in immunocompetent animal models must consider potentially significant alterations in healing, material absorption, and local fibrin degradation, in addition to the expected immune response; none of which may be relevant when Fibrin Pad is used in the clinical setting. These considerations are essential when standard efficacy and biocompatibility studies assessing Fibrin Pad are submitted for regulatory consideration or utilized as pre-clinical translational studies. © 2010 Elsevier Ltd. All rights reserved.


Noone C.,National University of Ireland, Maynooth | Kihm A.,LLC a Johnson and Johnson Company | English K.,National University of Ireland, Maynooth | O'Dea S.,National University of Ireland, Maynooth | Mahon B.P.,National University of Ireland, Maynooth
Stem Cells and Development | Year: 2013

Umbilical cord tissue represents a unique source of cells with potential for cell therapy applications for multiple diseases. Human umbilical tissue-derived cells (hUTC) are a developmentally early stage, homogenous population of cells that are HLA-ABC dim, HLA-DR negative, and lack expression of co-stimulatory molecules in the unactivated state. The lack of HLA-DR and co-stimulatory molecule expression on unactivated hUTC may account for their reduced immunogenicity, facilitating their use in allogeneic settings. However, such approaches could be confounded by host innate cells such as natural killer (NK) cells. Here, we evaluate in vitro NK cell interactions with hUTC and compare them with human mesenchymal stem cells (MSC). Our investigations show that hUTC suppress NK activation, through prostaglandin-E2 secretion in a contact-independent manner. Prestimulation of hUTC or human MSC with interferon gamma (IFN-γ) induced expression of the tryptophan degrading enzyme indoleamine 2, 3 dioxygenase, facilitating enhanced suppression. However, resting NK cells of different killer immunoglobulin-like receptor haplotypes did not kill hUTC or MSC; only activated NK cells had the ability to kill nonstimulated hUTC and, to a lesser extent, MSC. The cell killing process involved signaling through the NKG2D receptor and the perforin/granzyme pathway; this was supported by CD54 (ICAM-1) expression by hUTC. IFN-γ-stimulated hUTC or hMSC were less susceptible to NK killing; in this case, protection was associated with elevated HLA-ABC expression. These data delineate the different mechanisms in a two-way interaction between NK cells and two distinct cell therapies, hUTC or hMSC, and how these interactions may influence their clinical applications. © Copyright 2013, Mary Ann Liebert, Inc. 2013.


Friedrich F.,Ecole Polytechnique Federale de Lausanne | Friedrich F.,A Johnson and Johnson Company | Lockhart R.,Ecole Polytechnique Federale de Lausanne | Briand D.,Ecole Polytechnique Federale de Lausanne | And 9 more authors.
IEEE International Ultrasonics Symposium, IUS | Year: 2012

This work presents a light and powerful silicon based ultrasonic micro-cutter. In order to achieve high cutting efficiency as well as good controllability when driven by commercially available control systems, important design parameters haven been identified. They have been verified by FEM-simulation as well as experiments via laser Doppler vibrometer measurements and cutting tests. The samples have been manufactured cost-effectively by microfabrication batch processing and their cutting ability has been successfully demonstrated on chicken tissue, while driven in a typical frequency range from 50 kHz to 100 kHz, generating tip displacements up to 36 μmpp. © 2012 IEEE.


Haerri H.-P.,Federal Office of Metrology METAS | Deblock T.,A Johnson and Johnson Company | Pringalle P.,A Johnson and Johnson Company | Garcia J.,A Johnson and Johnson Company | And 3 more authors.
Accreditation and Quality Assurance | Year: 2012

A sampling method for the analysis of small amounts of gases from sealed containers is described. Liquefied pressurised gas samples were expanded into a vacuum box and statically diluted with ultrapure nitrogen. The equations for the sample dilution were established, relating the measured impurity amount fractions in the sample mixture to their partial pressures in the sealed container and, in the case of oxygen, to the air pressure. Ion-molecule reaction mass spectrometry allowed identification and measurement of trace impurities corresponding to partial pressures in the range of 1 hPa in the container. The method was applied for determining the identity and amount of gaseous impurities in n-butane used in implantable gas pressure-operated drug infusion pumps. Impurities from the n-butane supply cylinder or from decomposition products, for example due to the laser welding of the Ti plugs of the containers, could be excluded by the results of saturation vapour pressure measurements, FID gas chromatograms and IMR mass spectra. The variability in pressure versus volume among tested infusion pump samples was associated with excess oxygen, attributable to an excessive residual air pressure in the gas containers before they were filled with n-butane. The sample preparation method is principally applicable to measure the composition of small amounts of gas mixtures and gaseous impurities with identified IMR mass spectra down to trace levels-even for ubiquitous substances like oxygen. The volume of the produced gas mixtures allows characterisation of the gas by standard gas analytical methods and for impurities by trace gas analytical methods. © 2012 Springer-Verlag.


Ong W.,Inc. A Johnson and Johnson Company | Ong W.,Kala Pharmaceuticals, Inc. | Cheung E.Y.,Inc. A Johnson and Johnson Company | Schultz K.A.,Inc. A Johnson and Johnson Company | And 3 more authors.
CrystEngComm | Year: 2012

A form of bumetanide potassium trihydrate that is structurally similar to bumetanide sodium trihydrate was identified. Structural analysis indicated however that the change from sodium to potassium salt resulted in meaningful changes in the packing arrangement and even greater changes on physicochemical properties. The potassium trihydrate salt was five times more soluble in water relative to the sodium trihydrate salt (27 mg mL -1vs. 5.6 mg mL -1). Both salts underwent complete dehydration to their corresponding anhydrate forms following exposure to low humidity or elevated temperature. Arrhenius plots for the dehydration between 20-30 °C yielded a lower activation barrier for the potassium trihydrate compared to the sodium trihydrate (14.9 kcal mol -1vs. 19.9 kcal mol -1), translating into a 15-20-fold difference in the rate of dehydration. Such a 5.0 kcal mol -1 gap suggests that the H 2O molecules are more tightly bound in the sodium trihydrate compared to potassium trihydrate. These differences in solubility and rate of dehydration further illustrate that changes to chemical composition can have a meaningful and unpredictable impact on the physicochemical properties of closely related pharmaceutical salt forms. © The Royal Society of Chemistry 2012.


Andjelic S.,A Johnson and Johnson Company | Scogna R.C.,A Johnson and Johnson Company
Journal of Applied Polymer Science | Year: 2015

The intention of this study is to discuss scientific advances toward one very important challenge in the polymer processing industry: How does one increase the crystallization rate of slow-to-crystallize polymeric materials, thereby facilitating processing and enabling peak product performance? In the medical device field, where both government-controlled regulatory entities and medical professionals closely scrutinize the biocompatibility of added crystallization rate enhancers, achieving these twin goals has always been challenging. Herein, we present a review of various chemical and physical approaches used to tune the crystallization rate of semicrystalline polymers, with a strong emphasis on two novel approaches recently discovered and developed in our laboratories. © 2015 Wiley Periodicals, Inc.

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