7 research outputs found
Patients Beware: Preemption of Common Law Claims Under the Medical Device Amendments, 39 J. Marshall L. Rev. 75 (2005)
Chromosome level genome assembly of the Etruscan shrew Suncus etruscus
Abstract Suncus etruscus is one of the world’s smallest mammals, with an average body mass of about 2 grams. The Etruscan shrew’s small body is accompanied by a very high energy demand and numerous metabolic adaptations. Here we report a chromosome-level genome assembly using PacBio long read sequencing, 10X Genomics linked short reads, optical mapping, and Hi-C linked reads. The assembly is partially phased, with the 2.472 Gbp primary pseudohaplotype and 1.515 Gbp alternate. We manually curated the primary assembly and identified 22 chromosomes, including X and Y sex chromosomes. The NCBI genome annotation pipeline identified 39,091 genes, 19,819 of them protein-coding. We also identified segmental duplications, inferred GO term annotations, and computed orthologs of human and mouse genes. This reference-quality genome will be an important resource for research on mammalian development, metabolism, and body size control
Dendritic Cell Immunotherapy of Hepatitis C Virus Infection: Toxicology of Lipopeptide-Loaded Dendritic Cells
Before carrying out a clinical trial in humans in which a cell-based therapeutic anti-hepatitis C virus lipopeptide vaccine candidate is to be evaluated, a limited toxicological study was carried out. Murine bone marrow-derived dendritic cells (DCs) were loaded with lipopeptides containing HLA A2.1-restricted epitopes recognised by cytotoxic T lymphocytes (CTL) and then injected into C57BL6 mice by intradermal and intravenous routes. No significant behavioural changes, clinical symptoms or changes in body weight were observed when compared with a control group of animals receiving no treatment. One week after the third dose of lipopeptide-pulsed DC, mice were killed and blood samples taken for biochemical and hematological analyses. The liver, spleen and skin at the injection site were also collected and processed for histological analysis. Mild eosinophilia was observed at intradermal injection sites of animals receiving untreated as well as lipopeptide-loaded DCs. Despite a slight decrease in the size of livers of animals receiving lipopeptide-pulsed DCs, there was no evidence of inflammatory infiltrate or histological change. The only biochemical or hematological abnormality associated with the injection of lipopeptide-pulsed DC was a slight reduction in potassium levels. The evidence indicates that the lipopeptide vaccines per se are not cytotoxic and do not induce adverse events. On this basis, the TGA has granted clinical trial by exemption (CTX) approval for the proposed study using HCV lipopeptide-pulsed autologous DC to proceed in humans. This is the first approval of its kind in Australia setting a precedent for somatic cell immunotherapy of infectious disease. © 2005 Springer Science+Business Media, Inc.David C. Jackson, Georgia Deliyannis, Emily Eriksson, Irene Dinatale, Michael Rizkalla, and Eric J. Gowan