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Pellicelli A.M.,Liver Unit Azienda Ospedaliera San Camillo Forlanini | Romano M.,Liver Unit Ospedale Sandro Pertini | Stroffolini T.,Viale del Policlinico 155 | Mazzoni E.,Liver Unit Policlinico Casilino | And 18 more authors.
BMC Gastroenterology | Year: 2012

Background: The impact of viral subtype on the rate of sustained virological response (SVR) to antiviral therapy in patients chronically infected with hepatitis C genotype 1 subtype 1a and 1b has not been extensively investigated. The aim of this study is to determine whether the HCV genotype 1 subtypes 1a and 1b respond differently to treatment with PEGylated interferon (PEG-IFN) plus ribavirin.Methods: For 48 weeks, 388 " naïve" genotype 1 patients were treated weekly with PEG-IFN α-2a or PEG-INF α-2b combined with daily ribavirin (1000-1200 mg/day). The numbers of patients in whom HCV-RNA was undetectable were compared after 4 (rapid virological response, RVR), 12 (early virological response, EVR), and 48 (end treatment virological response, ETR) weeks of treatment as well as 24 weeks after the last treatment (sustained virological response, SVR).Results: The rate of SVR was higher in subtype 1a patients than subtype 1b patients (55% vs. 43%; p < 0.02). Multiple logistic regression analysis showed that infection with genotype 1a (odds ratio(OR) : 1.8; 95% confidence interval (CI): 1.4 to 4.1), age < 50 years (OR:7.0; 95% CI 1.1 to 21.2), alanine aminotransferase level (ALT)<100 IU/ml (OR:2.1; 95% CI: 1.3 to3.5), HCV-RNA < 5.6 log10 IU/ml (OR: 3.2; 95% CI: 2.7 to 6.9) and fibrosis score < S3 (OR: 3.8; 95% CI:3.2 to 7.4), were all independent predictors of SVR.Conclusion: Dual antiviral therapy is more effective against HCV subtype 1a than against subtype 1b and this difference is independent of other factors that may favour viral clearance.Trial registration: ClinicalTrials.gov Identifier: NCT01342003. © 2012 Pellicelli et al.; licensee BioMed Central Ltd.

Cardinale V.,University of Rome La Sapienza | Carpino G.,Foro Italico University of Rome | Gentile R.,University of Rome La Sapienza | Napoletano C.,Viale Regina Elena 324 | And 23 more authors.
BMC gastroenterology | Year: 2014

BACKGROUND: Efforts to identify cell sources and approaches for cell therapy of liver diseases are ongoing, taking into consideration the limits recognized for adult liver tissue and for other forms of stem cells. In the present study, we described the first procedure of via hepatic artery transplantation of human fetal biliary tree stem cells in patients with advanced cirrhosis.METHODS: The cells were immune-sorted from human fetal biliary tree by protocols in accordance with current good manufacturing practice (cGMP) and extensively characterized. Two patients with advanced liver cirrhosis (Child-Pugh C) have been submitted to the procedure and observed through a 12 months follow-up.RESULTS: The resulting procedure was found absolutely safe. Immuno-suppressants were not required, and the patients did not display any adverse effects correlated with cell transplantation or suggestive of immunological complications. From a clinical point of view, both patients showed biochemical and clinical improvement during the 6 month follow-up and the second patient maintained a stable improvement for 12 months.CONCLUSION: This report represents proof of the concept that the human fetal biliary tree stem cells are a suitable and large source for cell therapy of liver cirrhosis. The isolation procedure can be carried out under cGMP conditions and, finally, the infusion procedure is easy and safe for the patients. This represents the basis for forthcoming controlled clinical trials.

Dessy L.A.,Viale del Policlinico 155 | Mazzocchi M.,University of Rome La Sapienza | Corrias F.,University of Rome La Sapienza | Ceccarelli S.,University of Rome La Sapienza | And 2 more authors.
Plastic and Reconstructive Surgery | Year: 2014

Various vaginoplasty methods in male-to-female transsexuals have been described, but none is ideal. The use of cultured autologous oral epithelium to cover the neovagina walls is presented. Six patients were operated on. Complications encountered were one case of low-located rectovaginal fistula that was treated conservatively; one case of partial glans necrosis resulting in a scarred but sensitive clitoris; one case of large labia majora requiring reduction; and one case of short vagina requiring surgical revision with autologous cultured oral cells that was successful. All patients had adequate vagina, experienced sexual intercourse, and were satisfied with results. Autologous cultured oral epithelium transplantation is feasible, safe, and advantageous. Satisfactory neovaginas were provided; the procedure is relatively easy to perform and provides a thin, mucosa-lined neovagina with a sufficient amount of secretion. © 2013 by the American Society of Plastic Surgeons.

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