Temporal bone bank: complying with European union directives on human tissue and cells

Background

Availability of allograft tympano-ossicular systems (ATOS) provides unique reconstructive capabilities, allowing more radical removal of middle ear pathology. To provide ATOS, the University of Antwerp Temporal Bone Bank (UATB) was established in 1988. ATOS use was stopped in many countries because of safety issues concerning human tissue transplantation. Our objective was to maintain an ATOS tissue bank complying with European Union (EU) directives on human tissues and cells.

Methods

The guidelines of the Belgian Superior Health Council, including EU directive requirements, were rigorously applied to UATB infrastructure, workflow protocols and activity. Workflow protocols were updated and an internal audit was performed to check and improve consistency with established quality systems and changing legislations. The Belgian Federal Agency of Medicines and Health Products performed an inspection to examine compliance with national legislatives and EU directives on human tissues and cells. A sample of important procedures was meticulously examined in its workflow setting next to assessment of the infrastructure and personnel.

Results

Results are reported on infrastructure, personnel, administrative workflow, procurement, preparation, processing, distribution, internal audit and inspection by the competent authority. Donors procured: 2006, 93 (45.1%); 2007, 64 (20.6%); 2008, 56 (13.1%); 2009, 79 (6.9%). The UATB was approved by the Minister of Health without critical or important shortcomings. The Ministry accords registration each time for 2?years.

Conclusions

An ATOS tissue bank complying with EU regulations on human allografts is feasible and critical to assure that the patient receives tissue, which is safe, individually checked and prepared in a suitable environment.     

The Effect of Optokinetic Stimulation on Perceptual and Postural Symptoms in Visual Vestibular Mismatch Patients

BackgroundVestibular patients occasionally report aggravation or triggering of their symptoms by visual stimuli, which is called visual vestibular mismatch (VVM). These patients therefore experience discomfort, disorientation, dizziness and postural unsteadiness.ObjectiveFirstly, we aimed to get a better insight in the underlying mechanism of VVM by examining perceptual and postural symptoms. Secondly, we wanted to investigate whether roll-motion is a necessary trait to evoke these symptoms or whether a complex but stationary visual pattern equally provokes them.MethodsNine VVM patients and healthy matched control group were examined by exposing both groups to a stationary stimulus as well as an optokinetic stimulus rotating around the naso-occipital axis for a prolonged period of time. Subjective visual vertical (SVV) measurements, posturography and relevant questionnaires were assessed.ResultsNo significant differences between both groups were found for SVV measurements. Patients always swayed more and reported more symptoms than healthy controls. Prolonged exposure to roll-motion caused in patients and controls an increase in postural sway and symptoms. However, only VVM patients reported significantly more symptoms after prolonged exposure to the optokinetic stimulus compared to scores after exposure to a stationary stimulus.ConclusionsVVM patients differ from healthy controls in postural and subjective symptoms and motion is a crucial factor in provoking these symptoms. A possible explanation could be a central visual-vestibular integration deficit, which has implications for diagnostics and clinical rehabilitation purposes. Future research should focus on the underlying central mechanism of VVM and the effectiveness of optokinetic stimulation in resolving it.     

Modelling sediment supply to rivers and reservoirs in Eastern Europe during and after the collectivisation period

The present paper reports the results on the occurrence and composition of steady state phytoplankton assemblages in the shallow water bodies of 18 Bulgarian natural wetlands. They all differ in their morphometry, hydrology and trophic state. Steady states were identified according to Sommer & Padisák (1993) when (i) 1, 2 or 3 species of algae contribute more than 80% of total biomass, (ii) their existence or coexistence persists for long enough (more than 1–2 weeks) and (iii) during that period the total biomass does not increase significantly. These situations were rare and were dominated by 7 stress-tolerant, colony-forming and ruderal disturbance-tolerant cyanoprokaryotes (Microcystis aeruginosa, Microcystis wesenbergii, Anabaena spiroides, Anabaenopsis arnoldii, Aphanizomenon flos-aquae, Aphanizomenon gracile and Cylindrospermopsis raciborskii). The equilibrium states had been registered only during hypertrophic conditions in three stressed and frequently disturbed shallow water bodies and were related to the summer – late summer season.     

Novel selective human melanocortin-3 receptor ligands: use of the 4-amino-1,2,4,5-tetrahydro-2-benzazepin-3-one (Aba) scaffold

In search of new selective antagonists and/or agonists for the human melanocortin receptor subtypes hMC1R to hMC5R to elucidate the specific biological roles of each GPCR, we modified the structures of the superagonist MT-II (Ac-Nle-c[Asp-His-D-Phe-Arg-Trp-Lys]-NH(2)) and the hMC3R/hMC4R antagonist SHU9119 (Ac-Nle-c[Asp-His-D-Nal(2')-Arg-Trp-Lys]-NH(2)) by replacing the His-d-Phe and His-d-Nal(2') fragments in MT-II and SHU9119, respectively, with Aba-Xxx (4-amino-1,2,4,5-tetrahydro-2-benzazepin-3-one-Xxx) dipeptidomimetics (Xxx=D-Phe/pCl-D-Phe/D-Nal(2')). Employment of the Aba mimetic yielded novel selective high affinity hMC3R and hMC3R/hMC5R antagonists.     

Formulation and evaluation of ketorolac tromethamine-loaded albumin microspheres for potential intramuscular administration

The objective of this work was to prepare and evaluate ketorolac tromethamine-loaded albumin microspheres using a factorial design. Albumin microspheres were prepared by emulsion cross-linking method. Selected formulations were characterized for their entrapment efficiency, particle size, surface morphology, and release behavior. Analysis of variance (ANOVA) for entrapment efficiency indicated that entrapment efficiency is best fitted to a response surface linear model. From the statistical analysis it was observed that as the drug:polymer (D∶P) ratio and volume of glutaraldehyde increased, there was a significant increase in the encapsulation efficiency. Scanning electron microscopy of the microspheres revealed a spherical, nonporous and uniform appearance, with a smooth surface. Based on the entrapment efficiency and physical appearance, 9 formulations were selected for release study. The maximum particle size observed was below 40 μm. The release pattern was biphasic, characterized by an initial burst effect followed by a slow release. All selected microspheres, except those having less polymer proportion (D∶P ratio is 1∶1), exhibited a prolonged release for almost 24 hours. On comparingr ² values for Higuchi and Peppas kinetic models, different batches of microspheres showed Fickian, non-Fickian, and diffusion kinetics. The release mechanism was regulated by D∶P ratio and amount of cross-linking agent. From the experimental data obtained with respect to particle size and extent of drug relaase, it could be concluded that the prepared microspheres are useful for once-a-day intramuscular administration of ketorolac tromethamine. Published: February 23, 2007     

Distribution of twelve moist forest canopy tree species in Liberia and Côte d'Ivoire: response curves to a climatic gradient

Abstract. The occurrence and abundance of 12 canopy tree species from the moist tropical forests of West Africa have been studied in relation to a climatic gradient. We focused on environmental factors related to water availability: annual amount of rainfall, the length of the dry season, and cumulative water deficit. Species occurrence and abundance data are used for 39 forest sites in Liberia and southwest Côte d'Ivoire. Species responses are modelled using a set of five increasingly complex models, ranging from a no-trend model to a skewed bell-shaped response curve. The study species show different distribution patterns. Most of them suggest a close relationship to climatic conditions. Fitting of species occurrence data to each of the three climatic factors results in most cases in simple models. In only one out of 36 cases a bell-shaped response curve is needed to describe the data. Four of the 12 species show no response to the climatic factors when only occurrence is evaluated. When abundance data are used, in 33 of the 36 cases significant response models are found. In general these are much more complex than in the cases of species occurrence data: in 10 of the 36 cases a bell-shaped response model is found to describe the data best. This is in contrast with the widespread belief that species response curves are bell-shaped: within the forest zone in the area studied this is not generally the case. The importance of the three climatic factors for the distribution of the species is evaluated: for four species mean annual rainfall is the most important variable, for four species the length of the dry period, and for one species cumulative water deficit. Consequently, the assumption that mean annual rainfall is the most important factor determining tree species distribution in West African forests is not correct. Species response models to climatic factors show where species have their geographical optima. Implications for forest management are briefly discussed.     

Endoscopic procurement of tympano-ossicular allografts: alternative to the transcranial or retroauricular technique

A tympano-ossicular tissue bank complying with European Union regulations on human allografts is feasible and critical to assure that the patient receives tissue which is safe, individually checked and prepared in a suitable environment. The transcranial procurement technique has become the standard approach to procure tympano-ossicular allografts since the 1970s because it can provide en bloc allografts. Over the last 10–20 years, en bloc allografts have been abandoned and only the malleus (hammer) is left attached to the tympanic membrane. This modification enables introduction of the transmeatal procurement technique. Transmeatal procurement using readily available nasal 0° and 30° endoscopes is a feasible alternative which avoids contact with the dura mater and is not esthetically invasive to the donor. It involves a more time-consuming procurement but avoids the need for preparation of the temporal bone plug and is therefore generally more time-efficient.     

Plant Species Diversity in the Southern Part of the Taï National Park (Côte d’Ivoire)

Plant species diversity is surveyed in the southern part of the Taï National Park (TNP), Côte d’Ivoire. This park is the largest remaining tract of pristine forest in the West African rainforest biodiversity hotspot. Plant assemblages and environment factors were surveyed in 39 temporary 625-m² plots within three areas. The species list was completed thanks to itinerant prospections. TWINSPAN classification and detrended correspondence analysis were applied to the 39 relevés. We recorded a total of 916 plant species, including 169 West African endemics, that rises the floristic richness of TNP in 1233 species. Most plant species recorded were Guineo-Congolian species (90.9%) among which 8% were ‘Sassandrian species’, i.e. endemics of the extreme southwest Côte d’Ivoire. Eight of these endemics were exclusive of the southern part of TNP. The forest is very species-rich, particularly in Rubiaceae, Leguminosae and Euphorbiaceae. Most of the sampled species (59.5%) were erect phanerophytes with a dbh≤10 cm. We distinguished 7 plant community types, mainly determined by geomorphology and disturbance history. Lowland forests were typical dense evergreen forests with different degrees of maturity related to historical human impact. Inselbergs and swampy depressions provide an original azonal vegetation. We conclude that the southern part of TNP contributes significantly to the regional biodiversity hotspot since it includes the last remnants of primary evergreen rainforest and contains species assemblages from both higher rainfall biomes on moist soils derived from schist parent material and lower rainfall biomes on inselberg slopes and top. As anthropogenic disturbance clearly reduces biodiversity, these last remnants should be integrally protected.