Manufacturing Dendritic Cells for Immunotherapy: Monocyte Enrichment

Dendritic cells play a key role in activation of the immune system as potent antigen-presenting cells. This pivotal position, along with the ability to generate dendritic cells from monocytes and ready uptake of antigen, makes them an intriguing vehicle for immunotherapy for a variety of indications. Since the first reported trial using dendritic cells in 1995, they have been used in trials all over the world for a plethora of indications. Monocyte-derived dendritic cells are generated from whole blood or apheresis products by culturing enriched monocytes in the presence of interleukin (IL)-4 and granulocyte-macrophage colony-stimulating factor (GM-CSF). A variety of methods can be used for enrichment of monocytes for generation of clinical-grade dendritic cells and are summarized herein

Anomalous dielectric response of very small quantities of virgin, aged and failed silicone oil

A technique is described for making dielectric spectroscopy measurements of very small quantities (<1μl) of oil. The technique utilises surface tension to hold the oil between the plates of a capacitor, the inter-electrode distance being controlled by a micrometer. Breakdown strength can also be estimated using this technique. Three samples of silicone oil, used in cable sealing ends, were tested: virgin, used and failed. A major component in the frequency dependent impedance had the form Z(ω)=B(1-b)(iω)/sup.1-p/). This component was interpreted in terms of a fractal percolation model, and the anomalous thickness dependence predicted by the model verified by varying the inter-electrode distance. The difference observed for the three different samples indicate that conducting contaminants are responsible for the percolation system

Partial Exchange Transfusion For Polycythemia Hyperviscosity Syndrome

PARTIAL EXCHANGE TRANSFUSION FOR POLYCYTHEMIA HYPERVISCOSITY SYNDROME: A 21-YEAR REVIEW Bridget L. Hopewell, Laurie A. Steiner, Richard A. Ehrenkranz, Matthew J. Bizzarro, and Patrick G. Gallagher. Division of Perinatal Medicine, Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut. The objective of this study was to examine the use of partial exchange transfusion (PET) performed for polycythemia hyperviscosity syndrome (PHS) over time. A retrospective review of 141 infants who received a PET for PHS at Yale-New Haven Hospital, between 1986-2007 was performed, querying maternal and neonatal medical records. Patient demographics, risk factors for PHS, indications for PET, and complications associated with PET and PHS were collected. Overall, there was no change in the number of PET performed over the study period (r2=0.082, p=0.192). Eighty-eight percent of patients had at least one risk factor for PHS, most commonly maternal diabetes. Over time, there was a statistically significant decrease in maternal diabetes as a risk factor for PHS. Forty percent of patients had a significant complication attributed to PHS prior to PET. Eighteen percent of patients had a complication attributed to PET. Life-threatening complications of PHS or PET were rare. In conclusion, PHS continues to be a problem observed in neonatal intensive care units, particularly in at-risk populations. PHS and PET are associated with significant complications. Well designed studies with long-term follow up are needed to assess the risks and benefits of PET for PHS

Quality of reporting of trial abstracts needs to be improved: using the CONSORT for abstracts to assess the four leading Chinese medical journals of traditional Chinese medicine

<p>Abstract</p> <p>Background</p> <p>Due to language limitations, the abstract of journal article may be the only way for people of non-Chinese speaking countries to know about trials in traditional Chinese medicine (TCM). However, little is known about the reporting quality of these trial abstracts. Our study is to assess the reporting quality of abstracts of randomized controlled trials (RCT) published in four leading Chinese medical journals of TCM, and to identify any differences in reporting between the Chinese and English version of the same abstract publication.</p> <p>Method</p> <p>Two reviewers hand-searched the Chinese Journal of Integrated Traditional and Western Medicine, the Chinese Journal of Integrative Medicine, the China Journal of Chinese Materia Medica and the Chinese Acupuncture & Moxibustion for all abstracts of RCTs published between 2006 and 2007. Two reviewers independently assessed the reporting quality of the Chinese and English version of all eligible abstracts based on a modified version of the CONSORT for reporting randomised trials in journal and conference abstracts (CONSORT for abstracts).</p> <p>Results</p> <p>We identified a total of 345 RCTs of TCM with both a Chinese and English abstract. More than half of Chinese abstracts reported details of the trial participants (68%; 234/345), control group intervention (52%; 179/345), the number of participants randomized (73%; 253/345) and benefits when interpreting the trial results (55%; 190/345). Reporting of methodological quality or key features of trial design and trial results were poor; only 2% (7/345) included details of the trial design, 3% (11/345) defined the primary outcome, 5% (17/345) described the methods of random sequence generation, and only 4% (13/345) reported the number of participants analyzed. No abstracts provided details on allocation concealment and trial registration. The percentage agreement in reporting (between the Chinese and English version of the same abstract) ranged from 84% to 100% across individual checklist item.</p> <p>Conclusion</p> <p>The reporting quality of abstracts of RCTs published in these four TCM journals needs to be improved. Since none of the four journals adopted CONSORT for Abstracts, we hope that the introduction and adoption of CONSORT for Abstracts by TCM journals will lead to an improvement in reporting quality.</p

Improving returns from southern pine plantations through innovative resource characterisation

The southern pine resource includes slash pine (Pinus elliottii var. elliottii) [PEE], Caribbean pine (P. caribaea var. hondurensis) [PCH] and a locally-developed hybrid [PEE × PCH] (hybrid pine). These pines as well as smaller areas of loblolly pine (P. taeda) have been the main taxa planted in the coastal areas of southern Queensland and subcoastal areas of northern New South Wales for the last 25 years. The standard structural grade ranking of the southern pine resource is limited by its stiffness as characterised by the measurement of the Modulus of Elasticity (MOE). The MOE dictates the mechanical grade of the board (or other structural products, extracted from the log). A board’s market value is directly linked to its stress grade based on individual grading performance (e.g. MGP10). For example, 1 m³ of structural board (i.e. MGP10 and above) is worth about $350 whereas non-structural board (i.e. <MGP10) is worth about$80. Based on the importance of MOE, this report focusses on it as the key attribute for the southern pine. Non-destructive tools that accurately measure board MOE will allow enhanced genetic selection, site matching, harvest planning schedules, improved allocation of the resource to different processors and facilitate improved processor settings and product performance

Assessing the transparency of informed consent in feasibility and pilot studies: a single-centre quality assurance study protocol

Introduction Pilot/feasibility studies assess the feasibility of conducting a larger study. Although researchers ought to communicate the feasibility objectives to their participants, many research ethics guidelines do not comment on how informed consent applies to pilot studies. It is unclear whether researchers and research ethics boards clearly communicate the purpose of pilot studies to participants consenting. The primary objective of this study is to assess whether pilot/feasibility studies submitted for ethics approval to a research ethics board transparently communicate the purpose of the study to participants through their informed consent practice. A highly transparent consent practice entails the consent documents communicate: (1) the term ‘pilot’ or ‘feasibility’ in the title; (2) the definition of a pilot/feasibility study; (3) the primary objectives of the study are to assess feasibility; (4) the specific feasibility objectives; and (5) the criteria for the study to successfully lead to the main study. The secondary objectives are to assess whether there is a difference between submitted and revised versions of the consent documents (revisions are made to obtain research ethics approval), to determine factors associated with transparent consent practices and to assess the consistency with which pilot and feasibility studies assess feasibility outcomes as their primary objectives. Methods and analysis This is a retrospective review of informed consent information for pilot/feasibility studies submitted to the Hamilton integrated Research Ethics Board, Canada. We will look at submitted and revised consent documents for pilot/feasibility studies submitted over a 14-year period. We will use descriptive statistics to summarise data, reporting results as percentages with 95% CIs, and conduct logistic regression to determine characteristics associated with transparent consent practices. Ethics and dissemination The study protocol was approved by the Hamilton integrated Research Ethics Board, and the results of this study will be submitted for publication in a peer-reviewed journal

Can you believe what you read in the papers?

The number of reports of clinical trials grows by hundreds every week. However, this does not mean that people making decisions about healthcare are finding it easier to obtain reliable knowledge for these decisions. Some of the information is unreliable. Systematic reviews are helping to resolve this by bringing together the research on a topic, appraising and summarising it. But the quality of these reviews depends greatly on the quality of the studies, and this usually means the quality of their reports. If there are fundamental flaws within a study, such as the use of inappropriate 'randomisation' techniques in the context of reviews of the effects of interventions, the reviewers will not be able to fix these. Worse still, if they are not aware of underlying flaws, they might make incorrect judgements about the quality of the research in their review. A study by Wu and colleagues of 'randomised trials' from China provides a reminder of the cautious approach needed by users of scientific articles. They contacted the authors of more than 2000 research articles, which purported to be reports of randomised trials; and concluded that ten of every 11 studies claiming to be a randomised trial probably did not use random allocation. Better education of researchers, peer reviewers and editors about what is, and is not, a properly randomised trial is needed; along with better reporting of the details for how participants were allocated to the different interventions. Systematic reviewers must be cautious in making assumptions about the conduct of trials based on simple phrases about the trial methodology, rather than a full description of the methods actually used. It's not that you can't believe anything that you read in the papers, just that you cannot believe everything

Commercial Serological Tests for the Diagnosis of Active Pulmonary and Extrapulmonary Tuberculosis: An Updated Systematic Review and Meta-Analysis

An up-to-date systematic review and meta-analysis by Karen Steingart and colleagues confirms that commercially available serological tests do not provide an accurate diagnosis of tuberculosis

Tumor-infiltrating lymphocytes: Streamlining a complex manufacturing process

Adoptive cell therapy of tumor-infiltrating lymphocytes has shown promise for treatment of refractory melanoma and other solid malignancies; however, challenges to manufacturing have limited its widespread use. Traditional manufacturing efforts were lengthy, cumbersome and used open culture systems. We describe changes in testing and manufacturing that decreased the process cycle time, enhanced the robustness of critical quality attribute testing and facilitated a functionally closed system. These changes have enabled export of the manufacturing process to support multi-center clinical trials