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Volume 4 Toxicology: Open Access
ISSN: 2476-2067 Toxicology Congress 2018
March 12-14, 2018
March 12-14, 2018 Singapore
14th World Congress on
Toxicology and Pharmacology
Bridging the MOA and the POC for clinical application: A case study
Hanayuki Okura and Akifumi Matsuyama
National Institute of Biomedical Innovation, Health and Nutrition, Japan
Once the manufactured cells were assigned for cell-based medicinal products,
non-clinical studies shall be conducted. In the constructed non-clinical
study package including in vitro and/or in vivo studies: (1) the mode of action
(MOA) should be shown, (2) the proof of concept (POC) to be acquired and
(3) safety of the candidates be examined. In this presentation, we will focus on
MOA and POC and bridge these two concepts, in which adipose tissue-derived
multi-lineage progenitor cells (ADMPCs) would be developed as cell-based
medicinal products for liver fibrosis. To treat the patients with the liver cirrhosis,
the pathogenesis and pathophysiology should be concerned to the MOA. Liver
fibrosis is characterized by excessive accumulation of extracellular matrix with
inflammatory status in situ, therefore, in the developing cell-based medicinal products, anti-inflammatory cytokines and
fibrinolytic enzyme secretion is anticipated as MOA. After showing the appropriate MOA, the MOA and the POC should be
bridges and the key issues are what kind of animal models should be selected. In the case of the developing cell-based products,
MOA is that the cells act as vehicle for the delivery of anti-inflammatory cytokines and MMPs. Tetra carbon chloride (CCl4)-
chronic induction evolved radicals, followed by inflammation, resulted in fibrosis of the parenchyma. So, the expected mode
could be applicable in this animal model. To acquire the POC after bridging to MOA, the appropriate route of administration
(ROA) should be concerned. In the case study, the POC of the developing cell-based products by the improvement of liver
fibrosis, function by systemic administration of ADMPC. In conclusion it can be said that: (1) MOA should be planned from
the pathophysiology of the target diseases, (2) the POC-study should be designed to bridge to the MOA and (3) the applicable
limitation should be concerned in clinical use for the patients of the disease.
Recent Publications
1. Okura H, Morita M, Fujita M, Naba K, Takada N, Takagaki Y, Suzuki O, Matsuyama A (2017) Therapeutic potential of
adipose tissue-derived multi-lineage progenitor cell-sheets on liver fibrosis. Journal of Translational Science; 4: 1-6.
2. Negoro T, Okura H, Matsuyama A (2017) Induced Pluripotent Stem Cells: Global Research Trends. Biores Open Access; 6:
63-73.
Biography
Hanayuki Okura has completed her PhD degree from Osaka University Graduate School of Medicine. She was Research Fellowship for Young Scientists of Japan
Society for the Promotion of Science in her graduate school student years. She is currently the Deputy Director of Center for Rare Diseases Research, National
Institutes of Biomedical Innovation, Health and Nutrition, Japan.
Hanayuki Okura et al., Toxicol Open Access 2018, Volume 4
DOI: 10.4172/2476-2067-C1-006