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Aims: The aim of the SCIENCE trial was to investigate whether a single treatment with direct intramyocardial injections of adipose tissue‐derived mesenchymal stromal cells (CSCC_ASCs) was safe and improved cardiac function in patients with chronic ischaemic heart failure with reduced ejection fraction (HFrEF). Methods and results: The study was a European multicentre, double‐blind, placebo‐controlled phase II trial using allogeneic CSCC_ASCs from healthy donors or placebo (2:1 randomization). Main inclusion criteria were New York Heart Association (NYHA) class II–III, left ventricular ejection fraction (LVEF) <45%, and N‐terminal pro‐B‐type natriuretic peptide (NT‐proBNP) levels >300 pg/ml. CSCC_ASCs or placebo (isotonic saline) were injected directly into viable myocardium. The primary endpoint was change in left ventricular end‐systolic volume (LVESV) at 6‐month follow‐up measured by echocardiography. A total of 133 symptomatic HFrEF patients were included. The treatment was safe without any drug‐related severe adverse events or difference in cardiac‐related adverse events during a 3‐year follow‐up period. There were no significant differences between groups during follow‐up in LVESV (0.3 ± 5.0 ml, p = 0.945), nor in secondary endpoints of left ventricular end‐diastolic volume (−2.0 ± 6.0 ml, p = 0.736) and LVEF (−1.6 ± 1.0%, p = 0.119). The NYHA class improved slightly within the first year in both groups without any difference between groups. There were no changes in 6‐min walk test, NT‐proBNP, C‐reactive protein or quality of life the first year in any groups. Conclusion: The SCIENCE trial demonstrated safety of intramyocardial allogeneic CSCC_ASC therapy in patients with chronic HFrEF. However, it was not possible to improve the pre‐defined endpoints and induce restoration of cardiac function or clinical symptoms. [ABSTRACT FROM AUTHOR]

Aims: Ischaemic heart failure (IHF) patients have a poor prognosis even with current guideline-derived therapy. Intramyocardial injections of autologous or allogeneic mesenchymal stromal cells might improve cardiac function leading to better clinical outcome.Methods: The SCIENCE (Stem Cell therapy in IschEmic Non-treatable Cardiac diseasE) consortium has initiated a Horizon 2020 funded multicentre phase II study in six European countries. It is a double-blind, placebo-controlled trial testing the safety and efficacy of allogeneic Cardiology Stem Cell Centre Adipose-derived Stromal Cells (CSCC_ASC) from healthy donors or placebo in 138 symptomatic IHF patients. Main inclusion criteria are New York Heart Association class II-III, left ventricular ejection fraction < 45% and N-terminal pro-B-type natriuretic peptide levels > 300 pg/mL. Patients are randomized in a 2:1 pattern to receive intramyocardial injections of either CSCC_ASC or placebo. CSCC_ASC and placebo treatments are prepared centralized at Rigshospitalet in 5 mL vials as an off-the-shelf product. Vials are distributed to all clinical partners and stored in nitrogen vapour tanks ready to be used directly after thawing. A total of 100 × 106 CSCC_ASC or placebo are injected directly into viable myocardium in the infarct border zone using the NOGA XP system (BDS, Cordis, Johnson & Johnson, USA). Primary endpoint is a centralized core-laboratory assessed change in left ventricular end-systolic volume at 6-month follow-up measured by echocardiography. The trial started in January 2017, 58 patients were included and treated until July 2018.Conclusion: The SCIENCE trial will provide clinical data on efficacy and safety of intramyocardial cell therapy of allogeneic adipose-derived stromal cells from healthy donors in patients with IHF. [ABSTRACT FROM AUTHOR]

This article presents the results of a systematic review of international studies on economic and quality effects of contracting out published in the period from 2000 to 2014. We conducted a comprehensive search of the literature and identified 49 relevant studies. There are three main findings of the systematic review: (1) cost savings documented in international contracting out literature have been decreasing over time; (2) cost savings have been much greater in technical services than in social services; and (3) economic effects have been twice as large in Anglo-Saxon countries compared with other countries. With regard to measuring the effect of contracting out on service quality, which is a vital component of any service delivery arrangement, very few studies assess this issue in a comprehensive manner. There is also a significant lack of studies that include measures of transaction costs, thereby making it difficult to evaluate the impact of contracting out on overall cost-effectiveness of public service delivery. We conclude that generalization of effects from contracting out should be made with caution and are likely to depend, among other things, on the transaction costs characteristics of the service, the market situation and the institutional/regulatory setting. [ABSTRACT FROM AUTHOR]

The article presents a comparative analysis of the strategies applied by Danish and Norwegian patient organisations and organisations for disabled persons in order to promote the interests of their members. Three research questions are addressed: Are Danish and Norwegian patient organisations service organisations operating according to a 'logic of membership' or political pressure groups acting according to a 'logic of influence'? Do patient organisations apply 'insider' or 'outsider' strategies in their efforts to influence healthcare policies? What impact do different authority structures have on the patient organisations' influencing strategies? The latter question is related to recent reforms in the public healthcare systems of the two countries. The major responsibility for public hospitals now rests with regional authorities in Denmark and central government in Norway. The study is based on a survey among nationwide patient organisations in the two countries and shows that most patient groups are 'polyvalent''venue shoppers' combining a variety of influencing strategies. [ABSTRACT FROM AUTHOR]

The paper examines the Europeanization process and the impact of the European Union (EU) on national healthcare policies, using the example of Denmark. The analysis reveals that although health policy formally falls within the competence of member states, the impact of the EU is becoming increasingly conspicuous and has contributed to a gradual restructuring of healthcare boundaries as well as of some of its organizing principles. Furthermore, the process and impact have a de-structuring effect on the more traditional governance tools used in relation to healthcare. The paper concludes that the EU has a significant impact and that we may be witnessing the formation of a new institutional legacy that represents the initiation of a Europeanized healthcare model: a model emerging around a new set of stakeholders, principles and structures, which includes the market, principles of free movement, patient choice and patient rights institutionalized and safeguarded by the EU. [ABSTRACT FROM AUTHOR]

The article investigates the processes driving the ongoing Danish reform of the structure of the public sector with the purpose of understanding the factors rendering the reform possible at this particular juncture in time. For this reason, the article applies a theoretical framework consisting of John Kingdon's ‘Multiple Streams’ perspective combined with the Institutional Rational Choice approach developed by Fritz Scharpf, among others. As a heuristic tool for the analysis, the policy process is divided into the three phases of initiation, estimation and decision making. The analysis points to a rather complex process influenced by institutional and situational factors, including those of coincidence and external events. The process can be understood as a series of interrelated games in which bounded rational actors pursue their interests. In conclusion, the article finds that the speed and tight steering of the process left relatively little room for a broader public and political debate. The process leading to what has become the largest public sector reform in Denmark was in actuality determined by relatively few actors involved in decisive moments. [ABSTRACT FROM AUTHOR]