Ethical and Regulatory Challenges with Autologous Adult Stem Cells:A Comparative Review of International Regulations

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. Keywords: Stem cell research, cell therapy, bioethics, medical law, science regulatio

Ion-by-ion Cooling efficiencies

We present ion-by-ion cooling efficiencies for low-density gas. We use Cloudy (ver. 08.00) to estimate the cooling efficiencies for each ion of the first 30 elements (H-Zn) individually. We present results for gas temperatures between 1e4 and 1e8K, assuming low densities and optically thin conditions. When nonequilibrium ionization plays a significant role the ionization states deviate from those that obtain in collisional ionization equilibrium (CIE), and the local cooling efficiency at any given temperature depends on specific non-equilibrium ion fractions. The results presented here allow for an efficient estimate of the total cooling efficiency for any ionic composition. We also list the elemental cooling efficiencies assuming CIE conditions. These can be used to construct CIE cooling efficiencies for non-solar abundance ratios, or to estimate the cooling due to elements not explicitly included in any nonequilibrium computation. All the computational results are listed in convenient online tables.Comment: Submitted to ApJS. Electronic data available at http://wise-obs.tau.ac.il/~orlyg/ion_by_ion

Uncertainties in Theoretical HeI Emissivities: HII Regions, Primordial Abundance, and Cosmological Recombination

A number of recent works in astronomy and cosmology have relied upon theoretical He I emissivities, but we know of no effort to quantify the uncertainties in the atomic data. We analyze and assign uncertainties to all relevant atomic data, perform Monte Carlo analyses, and report standard deviations in the line emissivities. We consider two sets of errors, which we call "optimistic" and "pessimistic." We also consider three different conditions, corresponding to prototypical Galactic and extragalactic H II regions and the epoch of cosmological recombination. In the extragalactic H II case, the errors we obtain are comparable to or larger than the errors in some recent $Y_p$ calculations, including those derived from CMB observations. We demonstrate a systematic effect on primordial abundance calculations; this effect cannot be reduced by observing a large number of objects. In the cosmological recombination case, the errors are comparable to many of the effects considered in recent calculations.Comment: 5 pages, 3 figures, accepted to MNRAS Letter

Observationally constrained modeling of sound in curved ocean internal waves: Examination of deep ducting and surface ducting at short range

Author Posting. © Acoustical Society of America, 2011. This article is posted here by permission of Acoustical Society of America for personal use, not for redistribution. The definitive version was published in Journal of the Acoustical Society of America 130 (2011): 1173-1187, doi:10.1121/1.3605565.A study of 400 Hz sound focusing and ducting effects in a packet of curved nonlinear internal waves in shallow water is presented. Sound propagation roughly along the crests of the waves is simulated with a three-dimensional parabolic equation computational code, and the results are compared to measured propagation along fixed 3 and 6 km source/receiver paths. The measurements were made on the shelf of the South China Sea northeast of Tung-Sha Island. Construction of the time-varying three-dimensional sound-speed fields used in the modeling simulations was guided by environmental data collected concurrently with the acoustic data. Computed three-dimensional propagation results compare well with field observations. The simulations allow identification of time-dependent sound forward scattering and ducting processes within the curved internal gravity waves. Strong acoustic intensity enhancement was observed during passage of high-amplitude nonlinear waves over the source/receiver paths, and is replicated in the model. The waves were typical of the region (35 m vertical displacement). Two types of ducting are found in the model, which occur asynchronously. One type is three-dimensional modal trapping in deep ducts within the wave crests (shallow thermocline zones). The second type is surface ducting within the wave troughs (deep thermocline zones).Grants from the Office of Naval Research funded this work. Use of the vessels Ocean Researcher I and Ocean Researcher II in this experiment was funded by the Taiwan National Science Council

The RMS Survey: Mid-Infrared Observations of Candidate Massive YSOs in the Southern Hemisphere

Abridged abstract: The Red MSX Source (RMS) survey is an ongoing effort to return a large, well-selected sample of massive young stellar objects (MYSOs) within our Galaxy. A series of ground-based follow-up observations are being undertaken in order to remove contaminant objects from our list of 2000 candidates, and to begin characterising these MYSOs. As a part of these follow-up observations, high resolution (~1") mid-IR imaging aids the identification of contaminant objects which are resolved (UCHII regions, PN) as opposed to those which are unresolved (YSOs, evolved stars) as well as identifying YSOs near UCHII regions and other multiple sources. We present 10.4 micron imaging observations for 346 candidate MYSOs in the RMS survey in the Southern Hemisphere, primarily outside the region covered by the GLIMPSE Spitzer Legacy Survey. These were obtained using TIMMI2 on the ESO 3.6m telescope in La Silla, Chile. Our photometric accuracy is of order 0.05Jy, and our astrometric accuracy is 0.8", which is an improvement over the nominal 2" accuracy of the MSX PSC.Comment: 9 page paper accepted to A&A. Online data for table 2 and figure 1 will be available in the published online version of this paper via A&A. The paper contains 7 figures and 3 table

Autonomic modulation in patients with heart failure increases beat-to-beat variability of ventricular action potential duration

Background: Exaggerated beat-to-beat variability of ventricular action potential duration (APD) is linked to arrhythmogenesis. Sympathetic stimulation has been shown to increase QT interval variability, but its effect on ventricular APD in humans has not been determined.Methods and Results: Eleven heart failure patients with implanted bi-ventricular pacing devices had activation–recovery intervals (ARI, surrogate for APD) recorded from LV epicardial electrodes under constant RV pacing. Sympathetic activity was increased using a standard autonomic challenge (Valsalva) and baroreceptor indices were applied to determine changes in sympathetic stimulation. Two Valsalvas were performed for each study and were repeated, both off and on bisoprolol. In addition sympathetic nerve activity (SNA) was measured from skin electrodes on the thorax using a novel validated method. Autonomic modulation significantly increased mean short-term variability in ARI; off bisoprolol mean STV increased from 3.73 ± 1.3 to 5.27 ± 1.04 ms (p = 0.01), on bisoprolol mean STV of ARI increased from 4.15 ± 1.14 to 4.62 ± 1 ms (p = 0.14). Adrenergic indices of the Valsalva demonstrated significantly reduced beta-adrenergic function when on bisoprolol (Δ pressure recovery time, p = 0.04; Δ systolic overshoot in Phase IV, p = 0.05). Corresponding increases in SNA from rest both off (1.4 uV, p < 0.01) and on (0.7 uV, p < 0.01) bisoprolol were also seen.Conclusions: Beat-to-beat variability of ventricular APD increases during brief periods of increased sympathetic activity in patients with heart failure. Bisoprolol reduces, but does not eliminate, these effects. This may be important in the genesis of ventricular arrhythmias in heart failure patients

On the Origins of the High-Latitude H-alpha Background

The diffuse high-latitude H-alpha background is widely believed to be predominantly the result of in-situ recombination of ionized hydrogen in the warm interstellar medium of the Galaxy. Instead, we show that both a substantial fraction of the diffuse high-latitude H-alpha intensity in regions dominated by Galactic cirrus dust and much of the variance in the high-latitude H-alpha background are the result of scattering by interstellar dust of H-alpha photons originating elsewhere in the Galaxy. We provide an empirical relation, which relates the expected scattered H-alpha intensity to the IRAS 100um diffuse background intensity, applicable to about 81% of the entire sky. The assumption commonly made in reductions of CMB observations, namely that the observed all-sky map of diffuse H-alpha light is a suitable template for Galactic free-free foreground emission, is found to be in need of reexamination.Comment: 26 pages, 5 figures, Accepted for publication in Ap