Extensive characterization of the composition and functional activities of five preparations of human platelet lysates for dedicated clinical uses

Human platelet lysates (HPLs), rich in various growth factors and cell growth-promoting molecules, encompass a new range of blood products that are being used for regenerative medicine, cell therapies, and tissue engineering. Well-characterized dedicated preparations, tailor-made to best fit specific therapeutic applications, are needed for optimal clinical efficacy and safety. Here, five types of HPL were prepared from the same platelet concentrates and extensively characterized to determine and compare their proteins, growth factors, cytokines, biochemical profiles, thrombin-generating capacities, thrombin-associated proteolytic activities, phospholipid-associated procoagulant potential, contents of extracellular vesicles expressing phosphatidylserine and tissue factor, and antioxidative properties. Our results revealed that all five HPL preparations contained detectable supraphysiological levels, in the ca. 0.1 ~ 350-ng/ml range, of all growth factors assessed, except insulin-like growth factor-1 detected only in HPL containing plasma. There were significant differences observed among these HPLs in total protein content, fibrinogen, complement components C3 and C4, albumin, and immunoglobulin G, and, most importantly, in their functional coagulant and procoagulant activities and antioxidative capacities. Our data revealed that the biochemical and functional properties of HPL preparations greatly vary depending upon their mode of production, with potential impacts on the safety and efficacy for certain clinical indications. Modes of preparation of HPLs should be carefully designed, and the product properties carefully evaluated based on the intended therapeutic use to ensure optimal clinical outcomes

Hepatitis-C virus infection in Italy: A multicentric sero-epidemiological study. (A report from the HCV study group of the Italian Association for the Study of the Liver)

To assess possible geographical differences in the spread of hepatitis-C virus (HCV), the prevalence of antibodies against HCV (anti-C-100-3) was investigated in various adult population groups in 29 centres in Italy. Anti-HCV was positive in 375 out of 28,433 voluntary blood donors (1.3%): prevalence was higher in southern Italy (1.51%) than in the northern regions (1.28%), but the difference was not statistically significant. Anti-HCV prevalence was similar in the north and south in post-tranfusion chronic hepatitis (91%), haemophiliacs (73%), intravenous drug users (70%), and haemodialysis patients (28%), where parenteral contacts are obvious, and in HBsAg carriers (14%), a group with evidence of previous parenteral contamination. In contrast, anti-HCV prevalences were found to be significantly higher in the south than in the north and central Italy among patients with hepatocellular carcinoma (HCC) (73 vs 59%), cryptogenic liver disease (67 vs 58%), autoimmune chronic hepatitis (72 vs 44%) and alcoholic liver disease (51 vs 34%). These results indicate a very high circulation of HCV in Italy, with maximum incidence in the south and in the islands. They suggest that its spread in the community can occur through inapparent parenteral routes as observed for hepatitis-B (HBV) and hepatitis-delta viruses (HDV) and possibly facilitated by poorer social-demographic and lifestyle factors

Impact of nucleic acid testing for hepatitis B virus, hepatitis C virus, and human immunodeficiency virus on the safety of blood supply in Italy: A 6-year survey

BACKGROUND: Nucleic acid testing (NAT) for hepatitis C virus (HCV) and human immunodeficiency virus (HIV) has been implemented in several European countries and in the United States, while hepatitis B virus (HBV) NAT is still being questioned by opinions both in favor and against such an option, depending on the HBV endemicity, health care resources, and expected benefits. STUDY DESIGN AND METHODS: This survey was aimed to assess the NAT impact in improving the safety of blood supply in Italy, 6 years after implementation. The study involved 93 Italian transfusion centers and was carried out in 2001 through 2006. A total of 10,776,288 units were tested for the presence of HCV RNA, 7,932,430 for HIV RNA, and 3,405,497 for HBV DNA, respectively. RESULTS: Twenty-seven donations or 2.5 per million tested were HCV RNA-positive/anti-HCV-negative; 14 or 1.8 per million units tested were HIV RNA-positive/anti-HIV-negative; and 197 or 57.8 per million donations tested were HBV DNA-positive/hepatitis B surface antigen-negative. Of the latter, 8 (2.3/10(6)) were collected from donors in the window phase of infection and 189 (55.5/10(6)) from donors with occult HBV. Sixty-eight percent of the latter donors had hepatitis B surface antibody, 74.5 percent of whom with concentrations considered protective (>= 10 mIU/mL). CONCLUSION: NAT implementation has improved blood safety by reducing the risk of entering 2.5 HCV and 1.8 HIV infectious units per million donations into the blood supply. The yield of NAT in detecting infectious blood before transfusion was higher for HBV than for HCV or HIV. However, the benefit of HBV NAT in terms of avoided HBV-related morbidity and mortality in blood recipients needs to be further evaluated