Centralized intestinal organoid generation is a feasible and safe approach for personalized medicine as demonstrated in the HIT-CF Europe Organoid Study

BACKGROUND: Patient-derived intestinal organoids (PDIOs) show great potential as in vitro drug testing platform for personalised medicine in Cystic Fibrosis and oncology. PDIOs can be generated by culturing adult stem cells obtained through rectal forceps biopsy or suction biopsy, but the safety of these procedures and the success rates of generating organoids after shipment to a centralized lab using these procedures has not been studied in this context. We here report the safety and success rates of both biopsy procedures and the subsequent generation of PDIOs in the international multicentre HIT-CF Organoid Study. METHODS: 502 biopsy procedures were conducted, on 489 adult people with Cystic Fibrosis from 33 different hospitals across 12 countries. Depending on the preference of the hospital, either rectal forceps biopsies or suction biopsies were obtained and internationally shipped to a central laboratory for organoid generation. RESULTS: No adverse events were reported for 280 forceps biopsy procedures, while 222 rectal suction biopsy procedures resulted in 2 adverse events, namely continued bleeding and a probably nonrelated gastroenteritis. The success rate of organoid generation from all biopsies was 95%, and the main reason for failure was insufficient sample viability (3.2%). CONCLUSION: Our results indicate that both rectal suction biopsy and forceps biopsy procedures are safe procedures. The high success rates of PDIO generation from the obtained tissue samples demonstrate the feasibility of the organoid technology for personalised in vitro testing in an international setting

A Report of Edison Club in Hachinohe Institute of Technology (Part 7)

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The Study of Manufacture of a Conversion Electric Vehicle

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Интраоперационная оценка восстановления проведения импульса по спинному мозгу у пациентов с шейной спондилогенной миелопатией

The previous studies have data concerning surgery and diagnostic methods of cervical spondylotic myelopathy (CSM). The aim of this case was to study the on‑line assessment of the functions of corticospinal and somatosensory pathways changed due to surgical decompression of cervical spinal cord. Our study included 11 patients (6 men and 5 women, mean age 59,3 ± 9,2 years old) with MRI‑confirmed cervical spine stenosis (CSS). All of them had intraoperative neurophysiological monitoring standing for transcranial electric stimulation (TES) and recording of the median nerve somatosensory evoked potentials (SEP). Investigations were performed before and 10–15 minutes after surgical spinal cord decompression. The obtained data provides additional information about the spinal cord pathways functional status and it is a reliable predictor of neurological outcome.В литературе крайне мало встречается информации относительно восстановления проведения импульса по спинному мозгу в афферентном и эфферентном направлениях в ответ на декомпрессию в режиме реального времени, что и послужило основанием для проведения данной работы. Интраоперационному нейрофизиологическому мониторингу подверглось 11 пациентов (6 мужчин и 5 женщин, средний возраст 59,3 ± 9,2 года) с подтвержденным стенозом позвоночного канала по данным магнитно-резонансной томографии. Степень восстановления проведения по кортикоспинальному тракту и проводникам соматической афферентации оценивали с помощью регистрации вызванных моторных ответов (ВМО) при транскраниальной электростимуляции и записи соматосенсорных вызванных потенциалов (ССВП) при билатеральной стимуляции срединного нерва. Регистрацию ВМО и ССВП проводили до декомпрессии и через 10−15 мин после нее. Полученные данные отражают незамедлительное изменение проведения импульса в афферентном и/или эфферентном направлениях и коррелируют с неврологическим статусом в послеоперационном периоде

The persistence of cliques in the post-communist state. The case of deniability in drug reimbursement policy in Poland

This article explores a key question in political sociology: Can post-communist policy-making be described with classical theories of the Western state or do we need a theory of the specificity of the post-communist state? In so doing, we consider Janine Wedel's clique theory, concerned with informal social actors and processes in post-communist transition. We conducted a case study of drug reimbursement policy in Poland, using 109 stakeholder interviews, official documents and media coverage. Drawing on 'sensitizing concepts' from Wedel's theory, especially the notion of 'deniability', we developed an explanation of why Poland's reimbursement policy combined suboptimal outcomes, procedural irregularities with limited accountability of key stakeholders. We argue that deniability was created through four main mechanisms: (1) blurred boundaries between different types of state authority allowing for the dispersion of blame for controversial policy decisions; (2) bridging different sectors by 'institutional nomads', who often escaped existing conflicts of interest regulations; (3) institutional nomads' 'flexible' methods of influence premised on managing roles and representations; and (4) coordination of resources and influence by elite cliques monopolizing exclusive policy expertise. Overall, the greatest power over drug reimbursement was often associated with lowest accountability. We suggest, therefore, that the clique theory can be generalized from its home domain of explanation in foreign aid and privatizations to more technologically advanced policies in Poland and other post-communist countries. This conclusion is not identical, however, with arguing the uniqueness of the post-communist state. Rather, we show potential for using Wedel's account to analyse policy-making in Western democracies and indicate scope for its possible integration with the classical theories of the state.</p

Governing drug reimbursement policy in Poland: The role of the state, civil society, and the private sector

This article investigates the distribution of power in Poland’s drug reimbursement policy in the early 2000s. We examine competing theoretical expectations suggested by neopluralism, historical institutionalism, corporate domination, and clique theory of the post-communist state, using data from a purposive sample of 109 semi-structured interviews and documentary sources. We have four concrete findings. First, we uncovered rapid growth in budgetary spending on expensive drugs for narrow groups of patients. Second, to achieve these favorable policy outcomes drug companies employed two prevalent methods of lobbying: informal persuasion of key members of local cliques and endorsements expressed by patient organizations acting as seemingly independent “third parties.” Third, medical experts were co-opted by multinational drug companies because they relied on these firms for scientific and financial resources that were crucial for their professional success. Finally, there was one-way social mobility from the state to the pharmaceutical sector, not the “revolving door” pattern familiar from advanced capitalist countries, with deleterious consequences for state capacity. Overall, the data best supported a combination of corporate domination and clique theory: drug reimbursement in Poland was dominated by Western multinationals in collaboration with domestically based cliques.Piotr Ozieranski is indebted to the Department of Sociology, University of Cambridge and St Edmund’s College for research grants