32 research outputs found

    Stability Program in Dendritic Cell Vaccines: A “Real-World” Experience in the Immuno-Gene Therapy Factory of Romagna Cancer Center

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    Advanced therapy medical products (ATMPs) are rapidly growing as innovative medicines for the treatment of several diseases. Hence, the role of quality analytical tests to ensure consistent product safety and quality has become highly relevant. Several clinical trials involving dendritic cell (DC)-based vaccines for cancer treatment are ongoing at our institute. The DC-based vaccine is prepared via CD14+ monocyte differentiation. A fresh dose of 10 million DCs is administered to the patient, while the remaining DCs are aliquoted, frozen, and stored in nitrogen vapor for subsequent treatment doses. To evaluate the maintenance of quality parameters and to establish a shelf life of frozen vaccine aliquots, a stability program was developed. Several parameters of the DC final product at 0, 6, 12, 18, and 24 months were evaluated. Our results reveal that after 24 months of storage in nitrogen vapor, the cell viability is in a range between 82% and 99%, the expression of maturation markers remains inside the criteria for batch release, the sterility tests are compliant, and the cell costimulatory capacity unchanged. Thus, the data collected demonstrate that freezing and thawing do not perturb the DC vaccine product maintaining over time its functional and quality characteristics

    Detection and Investigation of Extracellular Vesicles in Serum and Urine Supernatant of Prostate Cancer Patients

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    none13no: Prostate Cancer (PCa) is one of the most frequently identified urological cancers. PCa patients are often over-diagnosed due to still not highly specific diagnostic methods. The need for more accurate diagnostic tools to prevent overestimated diagnosis and unnecessary treatment of patients with non-malignant conditions is clear, and new markers and methods are strongly desirable. Extracellular vesicles (EVs) hold great promises as liquid biopsy-based markers. Despite the biological and technical issues present in their detection and study, these particles can be found highly abundantly in the biofluid and encompass a wealth of macromolecules that have been reported to be related to many physiological and pathological processes, including cancer onset, metastasis spreading, and treatment resistance. The present study aims to perform a technical feasibility study to develop a new workflow for investigating EVs from several biological sources. Serum and urinary supernatant EVs of PCa, benign prostatic hyperplasia (BPH) patients, and healthy donors were isolated and investigated by a fast, easily performable, and cost-effective cytofluorimetric approach for a multiplex detection of 37 EV-antigens. We also observed significant alterations in serum and urinary supernatant EVs potentially related to BPH and PCa, suggesting a potential clinical application of this workflow.openSalvi, Samanta; Bandini, Erika; Carloni, Silvia; Casadio, Valentina; Battistelli, Michela; Salucci, Sara; Erani, Ilaria; Scarpi, Emanuela; Gunelli, Roberta; Cicchetti, Giacomo; Guescini, Michele; Bonafè, Massimiliano; Fabbri, FrancescoSalvi, Samanta; Bandini, Erika; Carloni, Silvia; Casadio, Valentina; Battistelli, Michela; Salucci, Sara; Erani, Ilaria; Scarpi, Emanuela; Gunelli, Roberta; Cicchetti, Giacomo; Guescini, Michele; Bonafè, Massimiliano; Fabbri, Francesc

    Breastfeeding and Respiratory Infections in the First 6 Months of Life: A Case Control Study

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    Background: Viral respiratory tract infections (VRI) are a major reason for hospitalization in children younger than 5 years. A case control study was conducted to investigate the potential role of breastfeeding in protecting children <1 year of age from VRI.Methods: Patients admitted for a respiratory tract infections routinely underwent a nasopharyngeal aspirate, which was tested with an RT-PCR for 14 respiratory viruses. Hospitalized infants positive for viruses were enrolled as cases; healthy controls were enrolled among patients admitted for ultrasound hip screening. The effect of breastfeeding on pertussis was investigated through multivariable analysis.Results: We enrolled a total of 496 patients: 238 cases and 258 healthy controls. Among cases, eighty-six patients (36.1%) had a rinovirus, 78 (32.8%) an RSV, 22 (9.2%) an adenovirus, and 37 (15.5%) a coinfections with multiple viruses. The number of households was significantly higher in cases (mean in cases 4.5; mean 3.7 in controls, p < 0.001) and the proportion of infants having siblings (79% in cases vs. 43% in controls, p < 0.001). Proportion of smoking mothers was higher in cases than in controls (21.4 vs. 10.1%, p = 0.001). Among cases 44.5% were exclusively breastfed at symptoms onset vs. 48.8% of healthy controls. According to the multivariable analysis, being exclusively breastfed at symptom onset was associated with a higher risk of viral respiratory infection (3.7; 95% CI 1.64–8.41), however a longer breastfeeding duration was protective (OR 0.98; 95% CI 0.97–0.99). Also having at least one sibling was associated to a higher risk (OR 3.6; 95% CI 2.14–5.92) as well as having a smoking mother (OR 2.6; 95% CI 1.33–4.89).Conclusions: Breastfeeding remains a mainstay of prevention for numerous diseases and its protective role increases with duration. However, being breastfed when mothers carry a respiratory infection may increase the risk of transmission, acting as a proxy for closer contacts. In future studies, potential confounding variables as pattern of contacts with other individuals, should be taken into account

    Correction to: Neuropsychological and internalizing problems in acute central nervous system infections: a 1 year follow-up

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    Correction The original article [1] contained an error mistakenly carried forward by the Production department handling this article whereby all authors’ names were incorrectly inverted. The original article has now been corrected to reflect the correct names of all authors

    Neuropsychological and internalizing problems in acute central nervous system infections: a 1 year follow-up

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    Abstract Background Acute central nervous system (ACNS) infections such as meningitis, encephalitis and cerebellitis still cause morbidity and mortality among children. The aim of this study was to verify whether neuropsychological impairment may develop in ACNS survivors. Methods The study included pediatric patients affected by ACNS disorders, aged 3-16 years admitted to the Bambino Gesù Children Hospital, Rome from June 2013 till June 2015. The patients and their parents underwent a psychological interview and neuropsychological tests during the first week of hospital admission and 1 year after, during a follow-up control. Wilcoxon signed rank tests for paired data were conducted to verify if the results were statistically importance. Patients underwent a cognitive profile test through the Leiter international performance scale – revised, motor skills evaluation through the test of visual-motor integration and a psychopathological evaluation by the child behavior checklist. The K-SADS-PL test was administered in children 6-11 years old to check psychopathological disorders. Results Forty-four patients were included in the study. At the 1 year follow-up, “anxiety problems” (dependency, fears, worries, nervousness) developed in 47% of patients, “somatic problems” (aches, headaches, nausea, vomiting) in 29% and “affective problems” (crying, self-harming, worthlessness, guilt, tiredness, sadness) in 29%. Visual perception was statistically increased at the 1 year follow-up in our patient cohort (p = 0.0297), mainly among the meningitides group (p = 0.0189). Motor-coordination also increased at the follow-up check in the study participants (p = 0.0076), especially in the group affected by cerebellitis (p = 0.0302). Conclusions Neuropsychological disorders are often difficult to recognize in the early stage. They must, however, be promptly identified through specific and standardized neuropsychological examinations in order to avoid long term sequelae in adulthood

    Prognostic role of serum concentrations of high-sensitivity C-reactive protein in patients with metastatic colorectal cancer: Results from the ITACa trial

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    Serum levels of C-reactive protein are (CRP) higher in patients with neoplastic conditions and numerous studies have been performed to clarify the etiologic and prognostic role of the high-sensitivity CRP (hs-CRP) in cancer. Our study was conducted on patients enrolled in the prospective randomized "Italian Trial in Advanced Colorectal Cancer (ITACa)" to assess hs-CRP levels and their impact on overall survival (OS) and progression-free survival (PFS). Serum samples from 132 ITACa patients were collected at baseline and 2 months after starting first-line chemotherapy. The supernatant was immediately transferred to cryovials and stored at -80°C. After thawing, hs-CRP was measured with the Cobas c501 analyzer. High levels of hs-CRP (≥ 13.1 mg/L) were associated with poorer median PFS (p < 0.0001) and OS (p < 0.0001) than low hs-CRP levels (< 13.1 mg/L). hs-CRP values in 107 patients were evaluated again after 2 months of therapy, revealing that patients with low hs-CRP levels in both baseline and second serum samples had the best median PFS and OS. Our study confirms the prognostic value of hs-CRP in patients with metastatic colorectal carcinoma

    Can Twitter Be a Source of Information on Allergy? Correlation of Pollen Counts with Tweets Reporting Symptoms of Allergic Rhinoconjunctivitis and Names of Antihistamine Drugs

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    <div><p>Pollen forecasts are in use everywhere to inform therapeutic decisions for patients with allergic rhinoconjunctivitis (ARC). We exploited data derived from Twitter in order to identify tweets reporting a combination of symptoms consistent with a case definition of ARC and those reporting the name of an antihistamine drug. In order to increase the sensitivity of the system, we applied an algorithm aimed at automatically identifying jargon expressions related to medical terms. We compared weekly Twitter trends with National Allergy Bureau weekly pollen counts derived from US stations, and found a high correlation of the sum of the total pollen counts from each stations with tweets reporting ARC symptoms (Pearson’s correlation coefficient: 0.95) and with tweets reporting antihistamine drug names (Pearson’s correlation coefficient: 0.93). Longitude and latitude of the pollen stations affected the strength of the correlation. Twitter and other social networks may play a role in allergic disease surveillance and in signaling drug consumptions trends.</p></div
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