Abstract：
:The regulatory environment for cell- and tissue-based therapeutic products and gene therapy products is rapidly evolving and drug regulatory agencies are working towards establishing a risk-based system in the regulatory framework. Similarly in Singapore, a risk-based tiered approach has been applied whereby clinical trials and product licence of high-risk cell- and tissue-based therapeutic products (substantially manipulated products, products intended for nonhomologous use or combined products) and gene therapy products are regulated as medicinal products under the Medicines Act. There is no legal definition for cell- and tissue-based therapeutic and gene therapy products. The current working definition for a cell- and tissue-based therapeutic product is an article containing or consisting of an autologous or allogeneic human cell or tissue that are used for or administered to, or intended to be used for or administered to, human beings for the diagnosis, treatment, or prevention of human diseases or conditions. Gene therapy products are included under the current biological medicinal product definition.
journal_name
Adv Exp Med Bioljournal_title
Advances in experimental medicine and biologyauthors
Goh CW,Kellathur SN,Ong LL,Wu Xdoi
10.1007/978-3-319-18618-4_11subject
Has Abstractpub_date
2015-01-01 00:00:00pages
195-212eissn
0065-2598issn
2214-8019journal_volume
871pub_type
杂志文章,评审abstract：:Consciousness, ranging from the primary, or perceptual, level to high levels that include a sense of self, can be identified in various organisms by a set of hallmarks that include behavioral, neural and phenomenal and/or informational. Behavioral hallmarks include those that indicate high cognitive abilities, such be...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-1-4614-1704-0_19
更新日期：2012-01-01 00:00:00
abstract：:The existence of chemo brain has become almost universally accepted, although many details of the concept are controversial. Data about the different types of cognitive impairment and their duration are not always consistent in the literature. We still do not know which cytotoxic agents are responsible, which characte...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-1-4419-6306-2_12
更新日期：2010-01-01 00:00:00
abstract：:Malignant brain tumors are among the most lethal of human tumors, with limited treatment options currently available. A complex array of recurrent genetic and epigenetic changes has been observed in gliomas that collectively result in derangements of common cell signaling pathways controlling cell survival, proliferat...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-0348-0837-8_4
更新日期：2014-01-01 00:00:00
abstract：:The views presented in this article are the fruit of reflections and discussion with my colleagues at Valladolid and with the members of the Sleep Apnea Hypopnea Syndrome Group of the CIBERES (Spain). We have assembled the article in three sections. In the first one we provide a mechanistic description of obstructive ...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-94-007-4584-1_45
更新日期：2012-01-01 00:00:00
abstract：:RPE65 is essential for both rod- and cone-mediated vision. So far, more than 120 disease-associated mutations have been identified in the human RPE65 gene. Differential clinical manifestations suggested that some patients suffer from null mutations while others retain residual RPE65 activity and some useful vision. To...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-3-319-17121-0_45
更新日期：2016-01-01 00:00:00
abstract：:To develop an osteochondral tissue regeneration strategy it is extremely important to take into account the multiscale organization of the natural extracellular matrix. The structure and gradients of organic and inorganic components present in the cartilage and bone tissues must be considered together. Another critica...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-319-76711-6_6
更新日期：2018-01-01 00:00:00
abstract：:Spinal muscular atrophies (SMA) are frequent autosomal recessive disorders characterized by degeneration of lower motor neurons. SMA are caused by mutations of the survival of motor neuron gene (SMN1) leading to a reduction of the SMN protein amount. The identification of SMN interacting proteins involved in the forma...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-90-481-2813-6_16
更新日期：2009-01-01 00:00:00
abstract：:We focus on dynamical descriptions of short-term synaptic plasticity. Instead of focusing on the molecular machinery that has been reviewed recently by several authors, we concentrate on the dynamics and functional significance of synaptic plasticity, and review some mathematical models that reproduce different proper...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-319-62817-2_3
更新日期：2017-01-01 00:00:00
abstract：:Time-resolved near-infrared spectroscopy (TRS-NIRS) allows absolute quantitation of deoxygenated haemoglobin and myoglobin concentration ([HHb]) in skeletal muscle. We recently showed that the spatial distribution of peak [HHb] within the quadriceps during moderate-intensity cycling is reduced with progressive hypoxia...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4939-3023-4_2
更新日期：2016-01-01 00:00:00
abstract：:The purpose of the paper was to investigate the usefulness of posturographic analysis in patients with rheumatoid arthritis (RA) and osteoarthritis (OA). RA is a chronic inflammatory disorder responsible for destruction of active and passive components of joints. It is the most common autoimmune disease, and the secon...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/5584_2014_29
更新日期：2015-01-01 00:00:00
abstract：:The effects of adenosine and its derivatives on binding of alpha 2-adrenergic receptor ligands with homogenates of rat vas deferens were examined. Adenosine and 2-chloradenosine increased the amount of [3H]clonidine binding. ATP had a slight effect, but AMP and adenine had none. The effect of adenosine was inhibited b...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4684-4805-4_11
更新日期：1984-01-01 00:00:00
abstract：:Fossilized insect specimens from the late Paleozoic Era (approximately 250 million years ago) were significantly larger than related extant species. Geologic estimates suggest that atmospheric oxygen in the late Paleozoic Era was 35%. These findings have led to a prominent hypothesis that insect body size may be limit...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-0-387-75434-5_17
更新日期：2007-01-01 00:00:00
abstract：:Thanks to recent improvements in NMR instrumentation, pulse sequence design, and sample preparation, a panoply of new NMR tools has become available for atomic resolution characterization of intrinsically disordered proteins (IDPs) that are optimized for the particular chemical and spectroscopic properties of these mo...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-319-20164-1_3
更新日期：2015-01-01 00:00:00
abstract：:What is the function of the Hox genes? At first glance, it is a curious question. Indeed, the answer seems so obvious that several authors have spoken of 'the Hox function' about some of the Hox genes, namely Hox3/zen and Hox6/ftz that seem to have lost it during the evolution of Arthropods. What these authors meant i...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-1-4419-6673-5_12
更新日期：2010-01-01 00:00:00
abstract：:We identified a 45 kDa Ca(2+)-dependent Lf binding protein on rat hepatocytes. Dithiobis(sulfosuccimidylproprionate) (DTSSP)-crosslinked 125I-Lf to a 45 kDa adduct in a Ca(2+)-dependent manner on intact cells. The 125I-labeled crosslinked complexes were absent when either surface-bound 125I-Lf was stripped prior to cr...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：
更新日期：1998-01-01 00:00:00
abstract：:DNA methylation, occurring at cytosines in CpG dinucleotides, is a potent mechanism of transcriptional repression. Proper genomic methylation -patterns become profoundly altered in cancer cells: both gains (hypermethylation) and losses (hypomethylation) of methylated sites are observed. Although DNA hypomethylation is...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-1-4419-9967-2_7
更新日期：2013-01-01 00:00:00
abstract：:As an attempt to recruit the third calcium binding site of thermitase into subtilisin BL, a Bacillus lentus alkaline protease (BLAP), the amino acid sequence from position 50 to 60 and position 92 was modified to the equivalent amino acids in thermitase. The resulting protein, designated BLAPm109, exhibited unusual bi...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4613-0319-0_27
更新日期：1996-01-01 00:00:00
abstract：:Autosomal dominant retinitis pigmentosa (adRP) is mainly caused by mutations responsible for rhodopsin (RHO) misfolding. Although it was previously proved that unfolded RHO is retained into the endoplasmatic reticulum (ER) eliciting ER-stress, consequent mechanisms underlying photoreceptor degeneration need to be furt...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-3-030-27378-1_51
更新日期：2019-01-01 00:00:00
abstract：:Gestational diabetes mellitus is a hyperglycaemic state first recognised in pregnancy. GDM affects both mother and child. Women with GDM and their new-borns are at risk of developing type 2 diabetes in the future. The screening and diagnostic criteria for GDM are inconsistent and thus novel biomarkers of GDM are requi...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-030-12668-1_12
更新日期：2019-01-01 00:00:00
abstract：:The level of tryptophan and 5-hydroxyindoleacetic acid were measured in the brain (striatum) of rats on tryptophan-deficient diet and tryptophan-enriched diet. We measured concentrations of tryptophan and 5-hydroxyindoleacetic acid in striatum by using microdialysis and HPLC methods. The extracellular level of tryptop...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4615-0135-0_60
更新日期：2003-01-01 00:00:00
abstract：:Asthma patients should be considered not only in terms of the medical aspects, but also the nonmedical issues associated with the psychological domain, since these are factors that can significantly improve patients' health state, quality of life, and illness acceptance, and can contribute to the reduction of healthca...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/5584_2016_192
更新日期：2017-01-01 00:00:00
abstract：:A comprehensive synthetic approach was employed to identify the continuous regions of T-cell recognition on the alpha-chain of Torpedo californica acetylcholine receptor (AChR). Eighteen synthetic consecutive overlapping peptides, of uniform size and overlaps, that spanned the entire extracellular part (residues 1-210...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4684-5442-0_8
更新日期：1987-01-01 00:00:00
abstract：:The effects of high hydrostatic pressure (HHP) on gel strength, microbial numbers, proteolytic activity, color and pH of Pacific whiting surimi gels were investigated. Strong gels without the use of protease inhibitors were formed with HHP treatments from 1-4 kBars. Gel strength was not affected by holding time. Total...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4899-1925-0_6
更新日期：1998-01-01 00:00:00
abstract：:Mesenchymal stem cells (MSCs) are multipotent stem cells that reside in various organs. They have the capacity to differentiate into various cell types, including cardiomyocytes, vascular endothelial cells, and vascular smooth muscle cells. Among the various MSCs, bone marrow-derived MSCs (BMMSCs) have been widely use...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-981-10-4397-0_12
更新日期：2017-01-01 00:00:00
abstract：:Gyrate atrophy is an autosomal recessive dystrophy in which night blindness starts early in the first decade of life. In the early stages, large areas of retinal pigment epithelium (RPE) and choriocapillaris (CC) atrophy in the far periphery (lobular shape, Fig. 37.1). (In choroideremia, atrophy appears in the mid per...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-319-95046-4_37
更新日期：2018-01-01 00:00:00
abstract：:Phenobarbital, when administered prenatally in a small dose to animals, produced profound, and permanent effects on reproductive function in the offspring. Preliminary analysis of a unique cohort of adolescents who were exposed to phenobarbital in utero, suggests that long-term effects are also evident in the human. T...
journal_title：Advances in experimental medicine and biology
pub_type： 临床试验,杂志文章,随机对照试验
doi：10.1007/978-1-4684-8047-4_9
更新日期：1991-01-01 00:00:00
abstract：:Pulmonary hypertension (PH) is a deadly and increasingly prevalent vascular disease characterized by excessive pulmonary vascular remodeling and right ventricular dysfunction which leads to right heart failure, multiorgan dysfunction, and premature death. The cause of the vascular remodeling in PH remains elusive, and...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-319-63245-2_24
更新日期：2017-01-01 00:00:00
abstract：:Diisocyanate-induced asthma is difficult to diagnose since the immunopathological mechanisms and exposure determinants at the workplace are not well defined. The aim of this study was to evaluate the non-invasive methods of nasal lavage fluid (NALF) and induced sputum (IS) to enhance the diagnostic efficiency. Sixty-t...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-94-007-6627-3_40
更新日期：2013-01-01 00:00:00
abstract：:The process of creating a translation-competent mRNA is highly complex and involves numerous steps including transcription, splicing, addition of modifications, and, finally, export to the cytoplasm. Historically, much of the research on regulation of gene expression at the level of the mRNA has been focused on either...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章,评审
doi：10.1007/978-3-030-31434-7_2
更新日期：2019-01-01 00:00:00
abstract：:With the object of examining the anti-tumour effect of exogenous interferon therapy in man a research programme has been initiated at the Karolinska Hospital. Established cell lines obtained from patients with Burkitt's and other types of lymphoma, leukaemia, osteosarcoma, mammary carcinoma and fibrosarcoma and from f...
journal_title：Advances in experimental medicine and biology
pub_type： 杂志文章
doi：10.1007/978-1-4615-9080-4_13
更新日期：1978-01-01 00:00:00
