Introduction In central nervous system neurodegenerative disorders, stem cell-based therapies should be considered as a promising therapeutic approach. The safe use of human Neural Stem Cells (hNSCs) ...for the treatment of several neurological diseases is currently under evaluation of phase I/II clinical trials. Clinical application of hNSCs require the development of GMP standardized protocols capable of generating high quantities of reproducible and well characterized stem cells bearing stable functional and genetic properties. Aim The aim of this study was to evaluate possible instabilities or modifications of the microsatellite loci in different culture passages because high culture passages represent an in vitro replicative stress leading to senescence. Experimental method: The hNSCs were characterized at different culture time points, from passage 2 to passage 25, by genetic typing at ten microsatellite loci. Conclusion We showed that genetic stability at microsatellite loci is maintained by the cells even at high passages adding a further demonstration of the safety of our hNSCs GMP culture method.
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DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
We report the analysis of 1 year of data from the first cohort of 15 patients enrolled in an open-label, first-in-human, dose-escalation phase I study (ClinicalTrials.gov: NCT03282760, ...EudraCT2015-004855-37) to determine the feasibility, safety, and tolerability of the transplantation of allogeneic human neural stem/progenitor cells (hNSCs) for the treatment of secondary progressive multiple sclerosis. Participants were treated with hNSCs delivered via intracerebroventricular injection in combination with an immunosuppressive regimen. No treatment-related deaths nor serious adverse events (AEs) were observed. All participants displayed stability of clinical and laboratory outcomes, as well as lesion load and brain activity (MRI), compared with the study entry. Longitudinal metabolomics and lipidomics of biological fluids identified time- and dose-dependent responses with increased levels of acyl-carnitines and fatty acids in the cerebrospinal fluid (CSF). The absence of AEs and the stability of functional and structural outcomes are reassuring and represent a milestone for the safe translation of stem cells into regenerative medicines.
Background. Italy has recently become land of immigration of people coming from geographical areas with high or medium endemia of Hepatitis B Virus. HBV-DNA shows the presence of that virus in blood.
...Materials and Methods. The aim of this study is to value the prevalence of HBV-DNA in patients coming to the Molecular Biology Laboratory of the Immuno-Haematology and Blood Transfusion Unit, AO “S. Maria”, Terni in 2012 focusing the areas of origin. HBV-DNA was analysed in 505 samples of plasma belonging to 328 individuals. The evaluation was related to sex and places of origin.
Results. Among the 328 individuals analysed, 149 were positive to HBV-DNA: 88 were Italian and 61 were foreigners. Male positivity to virus was higher than female. Nationality of origin were found for all the subjects except 2. Positive samples belong mostly to individuals from central Europe: 11 to Albania, 28 to Romania, 1 to Ukraine, 4 to Moldova, 1 to Bulgaria. 5 positive individuals were from Asia: 2 from Philippines and 3 from China. One positive man was French and 9 positive individuals were from Africa (Maghreb and Central Sub-Saharan Africa). Last positive individual was of unknown nationality.
Conclusions. The HBV prevalence among immigrants changes according to the geographical area of origin and it is higher in many other countries than Italy. Prevention and vaccination together with monitoring of HBV-DNA is strictly necessary for all the population autochthonous and not in this particular historical moment.
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