The Graft Processing subcommittee of the Worldwide Network for Blood and Marrow Transplantation wrote this guideline to assist physicians and laboratory technologists with the setting up of a cell ...processing laboratory (CPL) to support a hematopoietic stem cell transplant program, thereby facilitating the start-up of a transplant program in a new location and improving patient access to transplantation worldwide. This guideline describes the minimal essential features of designing such a laboratory and provides a list of equipment and supply needs and staffing recommendations. It describes the typical scope of services that a CPL is expected to perform, including product testing services, and discusses the basic principles behind the most frequent procedures. Quality management (QM) principles specific to a CPL are also discussed. References to additional guidance documents that are available worldwide to assist with QM and regulatory compliance are also provided.
Patients with HER2
breast cancer benefit from trastuzumab-containing regimens with improved survival. Adaptive immunity, including cytotoxic T-cell and antibody immunity, is critical to clinical ...efficacy of trastuzumab. Because Th cells are central to the activation of these antitumor effectors, we reason that HER2 patients treated with trastuzumab may benefit by administering vaccines that are designed to stimulate Th-cell immunity.
We developed a degenerate HER2 epitope-based vaccine consisting of four HLA class II-restricted epitopes mixed with GM-CSF that should immunize most (≥84%) patients. The vaccine was tested in a phase I trial. Eligible women had resectable HER2
breast cancer and had completed standard treatment prior to enrollment and were disease free. Patients were vaccinated monthly for six doses and monitored for safety and immunogenicity.
Twenty-two subjects were enrolled and 20 completed all six vaccines. The vaccine was well tolerated. All patients were alive at analysis with a median follow-up of 2.3 years and only two experienced disease recurrence. The percent of patients that responded with augmented T-cell immunity was high for each peptide ranging from 68% to 88%, which led to 90% of the patients generating T cells that recognized naturally processed HER2 antigen. The vaccine also augmented HER2-specific antibody. Immunity was sustained in patients with little sign of diminishing at 2 years following the vaccination.
Degenerate HLA-DR-based HER2 vaccines induce sustainable HER2-specific T cells and antibodies. Future studies, could evaluate whether vaccination during adjuvant treatment with trastuzumab-containing regimens improves patient outcomes.
Abstract Background CT coronary angiography (CTA) with 64 slice multi-detector CT (64-MDCT) has assumed an increasing role in clinical practice; however the high radiation dose associated with ...retrospective ECG-gated CTA has led to suggestions that a low dose prospectively gated strategy may be more appropriate. This study aims to assess the feasibility of this proposed strategy amongst standard referral for CTA in our centre. Methods We retrospectively analyzed 200 consecutive clinical CTA studies assessing the number of cardiac phases required to allow full diagnostic visualisation of the coronary tree. We assessed whether the pre-test likelihood of coronary disease, heart rate, heart rate variability and range, current beta-blockers use, coronary calcium score, breathing artefact or study quality affected the number of phases required. Results 125/200 patients (62.5%) required only a single phase for full diagnostic visualisation of the coronary tree most commonly 65% of the R–R interval—109/125 (87.2%). A successful diagnostic single cardiac phase was most likely in patients with a low heart rate (Heart rate < 70 bpm OR = 2.64; p = 0.003 and heart rate < 60 bpm OR = 4.81; p < 0.001 respectively) and low likelihood of coronary disease OR = 1.97 95% CI (1.09, 3.58) p = 0.025. Conclusion High image quality is possible using single phase analysis in those patients with low likelihood of coronary disease, low heart rates and full cooperation with inspiratory breath hold. In patients with HR of < 60, prospective ECG-gated acquisitions reduce radiation dose but may be non-diagnostic in as many as one third. Careful patient selection is therefore essential.
Objectives
We validate a novel CT coronary angiography (CCTA) coronary calcium scoring system.
Methods
Calcium was quantified on CCTA images using a new patient-specific attenuation threshold: mean + ...2SD of intra-coronary contrast density (HU). Using 335 patient data sets a conversion factor (CF) for predicting CACS from CCTA scores (CCTAS) was derived and validated in a separate cohort (
n
= 168). Bland–Altman analysis and weighted kappa for MESA centiles and Agatston risk groupings were calculated.
Results
Multivariable linear regression yielded a CF: CACS = (1.185 × CCTAS) + (0.002 × CCTAS × attenuation threshold). When applied to CCTA data sets there was excellent correlation (
r
= 0.95;
p
< 0.0001) and agreement (mean difference −10.4 95 % limits of agreement −258.9 to 238.1) with traditional calcium scores. Agreement was better for calcium scores below 500; however, MESA percentile agreement was better for high risk patients. Risk stratification was excellent (Agatston groups
k
= 0.88 and MESA centiles
k
= 0.91). Eliminating the dedicated CACS scan decreased patient radiation exposure by approximately one-third.
Conclusion
CCTA calcium scores can accurately predict CACS using a simple, individualized, semiautomated approach reducing acquisition time and radiation exposure when evaluating patients for CAD. This method is not affected by the ROI location, imaging protocol, or tube voltage strengthening its clinical applicability.
Key Points
•
Coronary calcium scores can be reliably determined on contrast
-
enhanced cardiac CT
•
This score can accurately risk stratify patients
•
Elimination of a dedicated calcium scan reduces patient radiation by a third
The widespread introduction of multidetector computed tomography (MDCT) into mainstream imaging departments has enabled many centres to undertake cardiac MDCT and, in particular, MDCT coronary ...angiography. This review highlights the areas that need consideration when introducing a new cardiac MDCT service and covers both technical and non-technical aspects. This includes equipment requirements, personnel, training, patient selection and preparation, cardiac CT protocols and post-processing techniques, and potential pitfalls.
Purpose
Primary ciliary dyskinesia (PCD) is a respiratory syndrome in which ‘random’ organ orientation can occur; with approximately 46% of patients developing situs inversus totalis at ...organogenesis. The aim of this study was to explore the relationship between organ anatomy and curve convexity by studying the prevalence and convexity of idiopathic scoliosis in PCD patients with and without situs inversus.
Methods
Chest radiographs of PCD patients were systematically screened for existence of significant lateral spinal deviation using the Cobb angle. Positive values represented right-sided convexity. Curve convexity and Cobb angles were compared between PCD patients with situs inversus and normal anatomy.
Results
A total of 198 PCD patients were screened. The prevalence of scoliosis (Cobb >10°) and significant spinal asymmetry (Cobb 5–10°) was 8 and 23%, respectively. Curve convexity and Cobb angle were significantly different within both groups between situs inversus patients and patients with normal anatomy (
P
≤ 0.009). Moreover, curve convexity correlated significantly with organ orientation (
P
< 0.001;
ϕ
= 0.882
)
: In 16 PCD patients with scoliosis (8 situs inversus and 8 normal anatomy), except for one case, matching of curve convexity and orientation of organ anatomy was observed: convexity of the curve was opposite to organ orientation.
Conclusions
This study supports our hypothesis on the correlation between organ anatomy and curve convexity in scoliosis: the convexity of the thoracic curve is predominantly to the right in PCD patients that were ‘randomized’ to normal organ anatomy and to the left in patients with situs inversus totalis.
Abstract There are currently no published studies of the impact of CT coronary angiography (CTA) on patient management or cost when compared with other established imaging techniques. We assessed the ...short term investigation and treatment costs of CTA compared with myocardial perfusion scintigraphy (MPS) using real clinical scenarios. Clinical information with either their CTA or MPS results were presented to 20 cardiologists in a random order. They decided further investigations and treatment required based on these data. Short term cost was calculated for each imaging strategy. Whilst the total number of further investigations requested did not differ between groups patients undergoing CTA were more likely to be referred for invasive coronary angiography, receive aspirin, statins, ACE inhibitors, β-blockers or clopidogrel. Overall cost and investigation costs were similar between CTA and MPS; however treatment costs were higher with CTA. There are significant differences in further clinical management when using CTA compared with MPS, in particular with greater use of secondary preventative medication.
The effects of α‐, γ/δ, and δ‐tocopherol concentrates (0.2–2.0%) alone and in combination with ascorbyl palmitate (0.1%) and lecithin (0.5%) on oxidative stability and flavor of fish oil were ...studied. Stability was assessed on oil stored in air at 20°C by peroxide value (PV) and off‐flavor formation. Polymer content, para‐anisidine value, and conjugation were used to characterize selected samples. When used alone, the protective effect of the tocopherols, as measured by PV, was δ≫γ/δ≫α, especially at the 2% concentration. Binary systems of ascorbyl palmitate‐lecithin and lecithin‐γ/δ or‐δ‐tocopherol were strongly synergistic in delaying peroxidation. The ternary blends provided the greatest protection against autoxidation. Refined fish oil with 2% δ‐tocopherol, 0.1% ascorbyl palmitate, and 0.5% lecithin showed no significant peroxidation at 20°C over a period of 6 mon. The original antioxidant effect noted for the ternary systems in delaying peroxidation was not reflected in improved flavor stability. Off‐flavors developed within 3 wk, making the oils unsuitable for use at high concentrations in ambient products that are unprotected from air.
Individual features of small airways disease depicted at computed tomography (CT) were correlated with functional indexes in patients with obliterative bronchiolitis.
Fifteen patients (all women) who ...fulfilled the strict criteria for diagnosis of obliterative bronchiolitis underwent thin-section CT at full inspiration and at end expiration. The CT scans were scored by two observers for extent of decreased attenuation of the lung parenchyma; end-expiration CT signs of air trapping; and bronchial dilation, wall thickening, and mucous plugging. The functional importance of each CT sign was evaluated.
Areas of decreased attenuation were present in all patients (median score at end expiration, 61%; range, 21%-83%). Bronchial wall thickening was identified in 13 of the 15 patients. Correlations of the extent of decreased attenuation and measures of air-flow obstruction were strongest between decreased attenuation at end expiration and air flow at low lung volumes (r(s) = -.70, P < .005). This relationship remained intact after correction for the severity of bronchial wall thickening.
In patients with obliterative bronchiolitis, the extent of decreased attenuation at CT was most strongly related to depression of pulmonary function tests of the small airways. Decreased attenuation is the cardinal sign for further quantitative studies of obliterative bronchiolitis.
PDF
