Good manufacturing practice-compliant validation and preparation of BM cells for the therapy of acute myocardial infarction

BACKGROUND: Intracoronary application of BM-derived cells for the treatment of acute myocardial infarction (AMI) is currently being studied intensively. Simultaneously, strict legal requirements surround the production of cells for clinical studies. Thus good manufacturing practice (GMP)-compliant collection and preparation of BM for patients with AMI was established by the Cytonet group. METHODS: As well as fulfillment of standard GMP requirements, including a manufacturing license, validation of the preparation process and the final product was performed. Whole blood (n=6) and BM (n=3) validation samples were processed under GMP conditions by gelafundin or hydroxyethylstarch sedimentation in order to reduce erythrocytes/platelets and volume and to achieve specifications defined in advance. Special attention was paid to the free potassium (<6 mmol/L), some rheologically relevant cellular characteristics (hematocrit <0.45, platelets <450 x 10(6)/mL) and the sterility of the final product. RESULTS: The data were reviewed and GMP compliance was confirmed by the German authorities (Paul-Ehrlich Institute). Forty-five BM cell preparations for clinical use were carried out following the validated methodology and standards. Additionally three selections of CD34+ BM cells for infusion were performed. All specification limits were met. Discussion In conclusion, preparation of BM cells for intracoronary application is feasible under GMP conditions. As the results of sterility testing may not be available at the time of intracoronary application, the highest possible standards to avoid bacterial and other contaminations have to be applied. The increased expense of the GMP-compliant process can be justified by higher safety for patients and better control of the final product.

CHANGE FOR GOOD? AN ASSESSMENT OF THE DISCONNECT BETWEEN PERCEIVED BENEFITS BY ENGOS AND USER SATISFACTION OF SOLAR BOTTLE LIGHTS IN INFORMAL SETTLEMENTS OF DHAKA CITY, BANGLADESH

A major challenge for a developing country such as Bangladesh is to supply basic services to its most marginalized populations, which includes both rural and urban dwellers. The government struggles to provide basic necessities such as water and electricity. In marginalized urban communities in Bangladesh, in particular informal settlements, meeting basic needs is even direr. Most informal settlements are built to respond to a rapid immigration to urban centers, and are thought of as ‘temporary structures’, though many structures have been there for decades. In addition, as the settlements are often squatting on private land, access to formalized services such as electricity or water is largely absent. In some cases, electricity and water connections are brought in - but through informal and non-government sanctioned ways -- these hookups are deemed ‘illegal’ by the state. My research will focus on recent efforts to help ameliorate issues associated with lack of basic services in informal settlements in Bangladesh – in this case lack of light. When the government fails to meet the needs of the general population, different non-government organizations tend to step in to intervene. A new emphasis on solar bottle systems in informal urban settlement areas to help address some energy needs (specifically day-time lighting). One such example is the solar bottle light in Bangladesh, a project introduced by the organization ‘Change’. There has been mixed reactions on this technology among the users. This is where my research intervenes. I have used quantitative method to investigate user satisfactions for the solar bottle lights among the residents of the informal settlements to address the overarching question, is there a disconnect between the perceived benefits of the ENGO and the user satisfaction of the residents of the informal settlements of Dhaka City? This paper uses survey responses to investigate level of user satisfaction and the contributing factors.

Pelvic floor stimulation: what are the good vibrations?

OBJECTIVE: The aim of this study was to determine if two different whole body vibration, sinusoidal vibration (SV) and stochastic resonance vibration (SRV), using various intensities lead to a reactive activation of pelvic floor muscles. STUDY DESIGN: We compared the pelvic floor muscle response of a healthy control group with that of a post partum group with weakened pelvic floor contraction. Activation effects of stochastic resonance vibration and sinusoidal vibration with six increasing vibration intensities were investigated using pelvic floor EMG and compared to activity during rest and maximum voluntary contraction. RESULTS: Both whole body vibration systems were able to activate pelvic floor muscles significantly depending on vibration intensity. Generally, the SRV achieved a significantly higher activation than maximum voluntary contraction, especially in women post partum and using a frequency of 6-12 Hz. CONCLUSION: SRV, compared to SV, leads to higher pelvic floor muscle activation in subjects with weakened pelvic floor muscles and achieves higher pelvic floor activation than maximum voluntary contraction alone. Neurourol. Urodynam. 28:405-410, 2009. (c) 2009 Wiley-Liss, Inc.

The art to keep in touch: The ''good use'' of Lagrange multipliers

Physically-based modeling for computer animation allows to produce more realistic motions in less time without requiring the expertise of skilled animators. But, a computer animation is not only a numerical simulation based on classical mechanics since it follows a precise story-line. One common way to define aims in an animation is to add geometric constraints. There are several methods to manage these constraints within a physically-based framework. In this paper, we present an algorithm for constraints handling based on Lagrange multipliers. After few remarks on the equations of motion that we use, we present a first algorithm proposed by Platt. We show with a simple example that this method is not reliable. Our contribution consists in improving this algorithm to provide an efficient and robust method to handle simultaneous active constraints.

Why Do We Think Practice Research is a Good Idea? Comments and Musings Inspired by the Salisbury Statement

In this paper I raise some questions about current understandings of practice research and whether they are worth pursuing. In particular, the notion of a gap between practice and research is examined in terms of how it constricts thinking about this issue. I also attempt to explicate some of the less examined assumptions associated with practice research. Finally, I suggest that we embrace multiplicity, not by trying to accommodate all views under the practice research umbrella, but by accepting that there will be many versions of practice research that will have differential appeal.

Is VHB-JOURQUAL2 a Good Measure of Scientific Quality? Assessing the Validity of the Major Business Journal Ranking in German-Speaking Countries

This study examines the question of whether the journal ranking VHB-JOURQUAL 2 can be considered as a good measure for the construct “scientific quality”. Various rankings in business research provide the database for the analysis. The correlations between theses rankings are used to assess the validity of VHB-JOURQUAL 2 along various validity criteria. The correlations with rankings that measure the same construct based on different methods show that VHB-JOURQUAL 2 has acceptable, but moderate convergent validity. The validity varies considerably across disciplines, showing that the heterogeneity of business administration is not sufficiently represented by this overall ranking. The variability is related to the variation in members per discipline represented by the German Association for Business Research. Furthermore, the measure shows a weak correlation with acceptance rates as an indicator of nomological validity in some disciplines.

The need for transparency and good practices in the qPCR literature

Two surveys of over 1,700 publications whose authors use quantitative real-time PCR (qPCR) reveal a lack of transparent and comprehensive reporting of essential technical information. Reporting standards are significantly improved in publications that cite the Minimum Information for Publication of Quantitative Real-Time PCR Experiments (MIQE) guidelines, although such publications are still vastly outnumbered by those that do not.