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Saito F.,Kansai Medical University | Nakatani T.,Kansai Medical University | Iwase M.,Kansai Medical University | Maeda Y.,Kansai Medical University | And 4 more authors.
Restorative Neurology and Neuroscience | Year: 2012

Purpose: To determine whether intrathecal administration of cultured autologous bone marrow stromal cells (BMSCs) is safe and feasible for treatment of subacute spinal injury. Methods: Five patients with complete tetraplegia due to cervical spinal injury on admission were included. A small amount of bone marrow was obtained during surgery for spinal fusion. BMSCs were cultured, reaching 10 7-10 8 cells. The properties and functional efficacy of the BMSCs were verified with surface marker analysis and a neurite extension test. BMSCs were administered by lumbar puncture. The patients were closely observed for 6 months, and the Committee on Effectiveness and Safety of Clinical Treatment (CESCT) evaluated safety. Results: No adverse responses were observed in biochemical and radiographic examinations. The CESCT did not recognize any harmful effects of the transplantation, and concluded it was safe for treatment. The patients were further followed up for 1 to 4 years with no adverse responses. The recovery of American Spinal Injury Association Impairment Scale (AIS) B and C patients at transplantation was rapid and remarkable, but gradual or limited in AIS A patients. Conclusion: This study demonstrated that intrathecal administration of cultured autologous BMSCs is safe and feasible for treatment of spinal cord injury. © 2012 - IOS Press and the authors. All rights reserved. Source

Fukushima M.,Translational Research Informatics Center
Transactions of Japanese Society for Medical and Biological Engineering | Year: 2014

In this lecture, the progress, the accomplishment, and the foresight of national programs initiated by MEXT and MHLW will be discussed. The outcomes from the Translational Research (TR) program started in FY 2007 and the subsequent program started in FY 2012 is remarkable, for example 22 IND trials registration (including 9 devices and 7 regenerating medicines), and 5 manufacturing and distribution approval (including 4 devices) by the regulatory agency, from the MEXT program. Thereby, research and development based on the Pharmaceutical Affairs Law became the common practice and the R&D pipeline in academic sector has been established. Should the new funding agency to be in operation in FY 2015, apply well-designed instructions and proposal forms for budget application, and rigorous review procedure based on the regulatory science principle, along with the precise project management, our country would become the most prominent innovation-oriented nation in the world. © 2014, Japan Soc. of Med. Electronics and Biol. Engineering. All rights reserved. Source

Kaneda H.,Okinaka Memorial Institute for Medical Research | Kaneda H.,Translational Research Informatics Center | Terashima M.,Toyohashi Heart Center | Yamaguchi H.,Tenyoukai Central Hospital
Current Atherosclerosis Reports | Year: 2012

New imaging techniques have been used to examine surrogate markers of atherosclerotic burden to determine the effects of pharmacologic intervention. In this review, we discuss the role of intravascular ultrasound (IVUS) in the determination of progression and regression of coronary artery disease. Several methodologic issues are discussed (selection of segments to analyze, measurement error, high drop out rate, and optimal IVUS variables). Usefulness of new IVUS-derived variables (plaque composition by radiofrequency analysis, deformability by palpography, and endothelial shear stress by three-dimensional coronary anatomy reconstructed from IVUS and angiography) will be determined. Based on comparisons between IVUS and clinical studies, IVUS variables seem to be a valid surrogate in studies using atorvastatin in patients with dyslipidemia. It remains unclear whether IVUS variables are valid surrogates for other drugs/diseases. As such, further studies are needed to determine whether IVUS can serve as an efficient surrogate for clinical events in coronary disease trials. © Springer Science+Business Media, LLC 2012. Source

Guo Q.-H.,Fudan University | Zhou B.,Translational Research Informatics Center | Zhao Q.-H.,Fudan University | Wang B.,Fudan University | Hong Z.,Fudan University
BMC Neurology | Year: 2012

Background: Mild cognitive impairment (MCI), defined as a transitional zone between normal cognition and dementia, requires a battery of formal neuropsychological tests administered by a trained rater for its diagnosis. The objective of this study was to develop a screening tool for MCI.Methods: One hundred ninety seven cognitively normal controls (NC), one hundred sixteen patients with amnestic MCI -single domain (aMCI-sd), one hundred ninety five patients with amnestic MCI-multiple domain (aMCI-md), and two hundred twenty eight patients with mild Alzheimer's disease (AD) were evaluated by comprehensive neuropsychological tests and by the Memory and Executive Screening (MES).Results: Correlation analysis showed that the three indicators of the MES were significantly negatively related with age (P<0.05), yet not related with education (P>0.05). There was no ceiling or floor effect. Test completion averaged seven minutes (421.14±168.31 seconds). The receiver operating characteristics (ROC) analyses performed on the aMCI-sd group yielded 0.89 for the area under the curve (AUC) (95% CI, 0.85-0.92) for the MES-total score, with sensitivity of 0.795 and specificity of 0.828. There was 81% correct classification rate when the cut-off was set at less than 75. Meanwhile, the aMCI-md group yielded 0.95 for the AUC (95% CI, 0.93-0.97) for the MES-total score, with sensitivity of 0.87 and specificity of 0.91, and 90% correct classification rate when the cut-off was set at less than 72.Conclusion: The MES, minimally time-consuming, may be a valid and easily administered cognitive screening tool with high sensitivity and specificity for aMCI, with single or multiple domain impairment. © 2012 Guo et al.; licensee BioMed Central Ltd. Source

Fujita Y.,Foundation Medicine | Kawamoto A.,Foundation Medicine | Kawamoto A.,Translational Research Informatics Center
Clinical Pharmacology and Therapeutics | Year: 2016

A new legal framework consisting of three laws for cell-based and tissue-based therapies went into effect in November 2014 in Japan. Among the provisions of the laws, the Pharmaceuticals, Medical Devices, and Other Therapeutic Products Act (PMD Act) allows conditional and time-limited approval for regenerative medical products based on the ensured safety and estimated efficacy in small-scale clinical trials. The new legislation is expected to accelerate safe and fast provision of the innovative products to patients with intractable diseases. © 2015 American Society for Clinical Pharmacology and Therapeutics. Source

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