Tips and Tricks for Validation of Quality Control Analytical Methods in Good Manufacturing Practice Mesenchymal Stromal Cell Production.

Mesenchymal stromal cells (MSC) for cellular therapy in European Union are classified as advanced therapy medicinal products (ATMPs), and their production must fulfill the requirements of Good Manufacturing Practice (GMP) rules. Despite their classification as medicinal products is already well recognized, there is still a lack of information and indications to validate methods and to adapt the noncompendial and compendial methods to these peculiar biological products with intrinsic characteristics that differentiate them from classic synthetic or biologic drugs. In the present paper, we present the results of the validation studies performed in the context of MSC development as ATMPs for clinical experimental use.

Evaluation of Real Time PCR Aspergillus spp. in bronchoalveolar lavage samples.

The present study investigated the improvement in the diagnosis of invasive pulmonary aspergillosis (IPA) adding a molecular test on bronchoalveolar lavage (BAL) to the routine diagnostic approach including microscopy, culture and galactomannan (GM) immunoassay. A total of 133 BAL samples were retrospectively tested for the Aspergillus DNA: 112 samples were from immunocompromised patients at risk of invasive fungal infection and 21 were from patients not at risk and without clinical evidence of IPA. The latter samples were used to identify the cut-off of positivity for the molecular test.

HEV and HAV seroprevalence in men that have sex with men (MSM): An update from Milan, Italy.

Hepatitis E virus (HEV) is a feco-orally transmitted pathogen and one of the most common cause of acute hepatitis worldwide. Recent studies in developed countries suggested that a direct human-to-human contact such as for sexually transmitted diseases may play a significant role in the HEV spread. The aim of this study was to investigate the seroprevalence of HEV and HAV in a group of MSM, including subjects HIV, and Treponema infected, in Milan, Italy.

Quantification of Core Antigen Monitors Efficacy of Direct-acting Antiviral Agents in Patients With Chronic Hepatitis C Virus Infection.

Background & Aims: Widespread use of direct-acting antiviral (DAA) agents to treat patients with hepatitis C virus (HCV) infection has reduced the need for monitoring of HCV RNA levels, because viral kinetics do not predict sustained virologic response (SVR) to these drugs. However, the performance of cheaper tests such as the assay to quantify HCV core antigen (HCV Ag) has not been determined. We investigated the accuracy of the HCV Ag test in predicting which patients receiving DAAs will achieve SVRs at week 12 (SVR12).

Enterovirus-D68 in the Cerebrospinal Fluid of Two Children with Aseptic Meningitis.

This case report describes two previously healthy children with aseptic meningitis whose cerebrospinal fluid was positive for enterovirus-D68, which indicates direct involvement of this infectious agent in the development of this neurologic disease.

Seroprevalence of West Nile virus antibodies in blood donors living in the metropolitan area of Milan, Italy, 2009-2011.

A seroprevalence study for anti-West Nile virus-specific antibodies was carried out in healthy blood donors resident in the metropolitan area of Milan in two different years, 2009 and 2011. In 2009 no positive sera were found, whereas 5 positive sera were found in 2011, revealing viral circulation in this naive area. The seroprevalence rate identified in 2011 was 0.

Iron reduction and sustained response to interferon-alpha therapy in patients with chronic hepatitis C: results of an Italian multicenter randomized study.

Objectives: It has been suggested that iron depletion improves the response to interferon in patients with chronic hepatitis C. We aimed to evaluate whether iron reduction by phlebotomy before interferon improves the rate of virological sustained response in previously untreated noncirrhotic patients.

Methods: One hundred fourteen hepatitis C virus (HCV) RNA positive patients with hepatic iron concentrations of > or =700 microg/g dry wt (men) and > or =500 microg/g dry wt (women), stratified according to HCV genotype and gamma-glutamyltransferase values, were randomly allocated to interferon alone (6 MU three times a week) (group A) or to phlebotomy until iron depletion followed by interferon (6 MU three times a week) (group B).