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1 CONTENTS
2 Vol TEL / FAX henshu@imic.or.jp TEL / FAX
3 48(1)
4 ALPALP endochondral ossification membranous ossification 24 1 embryonic stem cell ES 1) RNA ipsinduced pluripotent stem cells 2,3 ESiPS 49(2)
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6 2in vitro 3 / 5,14) 3C 14) Friedenstein 12) diffusion chamber chamber 200um 3A 13) 4 3B (4)
7 5 1) Thomson JA, et.al. Embryonic stem cell lines derived from human blastocysts. Science 282 : , ) Takahashi, K., Yamanaka, S. Induction of pluripotent stem cells from mouse embryonic and adult fibroblast cultures by defined factors. Cell. 126: ) Takahashi, K., Tanabe, K., Ohnuki, M., Narita, M., Ichisaka, T., Tomoda, K., Yamanaka, S. Induction of pluripotent stem cells from adult human fibroblasts by defined factors. Cell. 131: , ) Caplan AI. Mesenchymal stem cells. J Orthop Res. 9:641-50, ) Ohgushi H, Caplan AI., Stem cell technology and bioceramics: from cell to gene engineering. J Biomed Mater Res.;48(6): , ) Dezawa M, et.al. Specific induction of neuronal cells from bone marrow stromal cells and application for autologous transplantation J Clin 52(5)
8 Invest. 113(12): ) Nagaya N, et. al. Intravenous administration of mesenchymal stem cells improves cardiac function in rats with acute myocardial infarction through angiogenesis and myogenesis. Circulation.;112: ) Ikeda E, et.al. Multipotent cells from the human third molar: feasibility of cell-based therapy for liver disease. Differentiation 76: , ) Ohgushi H, Dohi Y, Katuda T, Tamai S, Tabata S, Suwa Y, In vitro bone formation by rat marrow cell culture. J Biomed Mater Res. 32(3): ) Kihara T, Oshima A, Hirose M, Ohgushi H. Threedimensional visualization analysis of in vitro cultured bone fabricated by rat marrow mesenchymal stem cells. Biochem Biophys Res Commun. 316(3):943-8, ) Ohgushi H, et al: Tissue engineered ceramic artificial joint ex vivo osteogenic differentiation of patient mesenchymal cells on total ankle joints for treatment ofosteoarthritis, Biomaterials 26: , ) Friedenstein A, et al. Origin of bone marrow stromal mechanocytes in radiochimeras and in heterotopic transplants. Exper Hematol. 6: ) Ohgushi,H., Goldberg,V.M., Caplan,A.I. Heterotopic osteogenesis in porous ceramics induced by marrow cells. J Orthop Res7: , ) Yoshikawa T, Ohgushi H, Tamai S. Immediate bone forming capability of prefabricated osteogenic hydroxyapatite. J Biomed Mater Res. 32(3):481-92, ) Morishita T, Honoki K, Ohgushi H, Kotobuki N, Matsushima A, Takakura Y. Tissue engineering approach to the treatment of bone tumors: three cases of cultured bone grafts derived from patients' mesenchymal stem cells, Artif Organs 30: , ) Kawate K, et. al. Tissue-engineered approach for the treatment of steroid-induced osteonecrosis of the femoral head: transplantation of autologous mesenchymal stem cells cultured with betatricalcium phosphate ceramics and free vascularized fibula, Artif Organs. 30(12):960-2, ) Tohma Y., Tanaka,Y., Ohgushi,H., Tadokoro M, Akahane M, Tanaka Y. Early bone in-growth ability of alumina ceramic implants loaded with tissue-engineered bone. J Orthop Res 24(4): , ) Bartholomew A et al.: Mesenchymal stem cells in the induction of transplantation tolerance. Transplantation 15: 55-7, Review ) Kotobuki N, Katsube Y, Katou Y, Tadokoro M, Hirose M, Ohgushi H. In vivo survival and osteogenic differentiation of allogeneic rat bone marrow mesenchymal stem cells (MSCs). Cell Transplant 17:705-12, ) Tadokoro M, Kanai R, Taketani T, Uchio Y, Yamaguchi S, Ohgushi H, New bone formation by allogeneic mesenchymal stem cell transplantation in a patient with perinatal hypophosphatasia.j Pediatr 154:924-30, ) Katsube Y, et al.: Restoration of cellular function of mesenchymal stem cells from a hypophosphatasia patient. Gene Ther, 17: , ) Oda Y, et.al. Induction of pluripotent stem cells from human third molar mesenchymal stromal cells. J Biol Chem. 285: (6)
9 Morizane Toshio t 2 ICTInformation and communication technology JavaScriptInternet ExplorerSafariChrome Kaplan-Meier 2 : S(t) = e - t = exp(-t) t S(t) exponential Microsoft Excel exp() e ts(t) 0.5 Median survival time Mean survival timemst ln[s(t)] = -t = -ln[s(t)]/t MST = -ln(0.5)/ = -ln(0.5)/mst 2 54(7)
10 Hazard ratiohr 2 1 MST 0 1MSTMST0 MSTMST1 HR =1 / 0 0 = -ln(0.5)/mst0 1 = -ln(0.5)/mst1 HR = MST0 /MST1 MST HRHR1.0 Microsoft Excel 1 Center for Clinical TrialsCCT( cuhk.edu.hk/cctwebsite/default.aspx SevicesBiostatistics Sample size estimation www. cct.cuhk. edu. hk/stat/index. htmsurvival Analysis Comparison of Two Survival Curves - Rubinstein 2 Input Calculate MST B10C10 MST5 30%MST 2.88D2E3D4E4D5E5 D10D11E10E11 2 HR1.0 MST10 15HR = 15/10 = MSTHR 2Center for Clinical TrialsCCT 1) Cox 2) Rubinstein, Gail, Santner: Planning the duration of a comparative clinical trial with loss to follow-up and a period of continued observation. J Chron Dis : Bernstein D and Lagakos SW: Sample size and power determination for stratified clinical trials. Journal of Statistical Computation Simulation 19788:65-73.Logrank Logrank Logrank2Lakaktos E: Sample sizes based on the logrank statistic in complex clinical trials. Biometrics 1988;44: (8)
11 0.05 one-sided test2 two-sided test >1.0 MST MS MSTMS T0TT - T0 QCQEQC 1:1 0.5QE 1 1: : T0Accrual duration (month) T - T0 Calculate NNC NED 2 MST10 MST14MS QCQE T024T-T David A. Schoenfeld, Ph.D. 3Schoenfeld 56(9)
12 Massachusetts General Hospital Mallinckrodt General Clinical Research Center Research Resources Division, National Institutes of Health, General Clinical Research Center Program Statistical considerations for clinical trials and scientific experiments mgh.harvard.edu/ sample_size/size.html Time to eventfind statistical considerations for a study where the outcome is a time to failure harvard.edu/sample_size/time_to_event/para_time.ht ml CALCULATE Power 3 1.Power2.Hazard ratio 32 3Hazard ratiopower Power analysis 1.Power3 CALCULATE Cancer Research And BiostatisticsCRABhttp:// Calculators Tools Two Arm Survival4 Southwest Oncology Group (SWOG) SWOG Stratum 1 Proportion 1.0 Stratum 1 Proportion 0.5 Stratum 2 Proportion 0.5 Hazard rate, std.hazard rate, exp. 2 Type calculation Sample Size Type input Hazard RatesSided 2 5CRAB 4Cancer Research And BiostatisticsCRAB SidedNumber strata 1Proportion in standard group110.5alpha0.05 Years of accrual24years of followup24hazard ratio 1.4Power 0.8Stratum 1 Proportion1Stratum 1Hazard rate, std MST 10 Accrual ratetotal accrual Calculate5 57(10)
13 62 Total accrual Stratum 1Hazard rate, std MST1 1Hazard rate, std Hazard rate, std %2 40% Number strata26 Calculate 7320 Accrual rate JavaScript PC PC iosipadipod touch, iphoneandroidos URL 3JavaScript PC JavaScript Math.exp(n) Math.sqrt(n) Math.pow(n, m) Math.max(x, y) Math.min(x, y)math.random() 58(11)
14 Shigeaki Yamazaki 1 honest error 1988 ICMJE International Committee of Medical Journal Editors URMUniform Requirements for Manuscripts Submitted to Biomedical Journals PubMed/Medline 2 PubMed/MedlinePubMed publication typeretracted publication Japan retracted publication publication type Japan all field ProCite retraction notice or honest error 9 Web Medline Wager & Williams 3 PubMed ,260,731655, % %112PubMed 6.8% 5.8% PubMed % % (12)
15 retraction notice FFP fabricationfalsification plagiarism % or Journal of Biological Chemistry FFP46 47% FFP 5 21Journal of Immunology2 Infection and Immunity 9Clinical and Experimental Immunology 1PubMed PubMed Jan 24, 2011(N=98) 1 2FFP Honest error5 Pub Med Jan 24, (13)
16 Journal of Biological Chemistry Biochemical and Biophysical Research Communications Nature MedicineScienceNature Wager & Williams Medline Web 4 Wager & Williams Wager & Williamsnot replicate findings data used without permission Wager & Williams 39% 21%9% FFP30%FFP 17% 31%FFP 47%3 Wager & Williams21% 42% FFP Wager & Williams5%6% Wager & Williams 43 61(14)
17 Web 3% FFPMedline Web 15% Wager & Williams 1 International Committee of Medical Journal Editors. Retraction of research findings. Ann Intern Med 1988; 108(2): Web. 2011; 32(2): Wager E, Williams P. Why and how do journals retract articles? An analysis of Medline retractions J Med Ethics 2011; 37(9): (15)
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21 IMIC SELIMIC SafEty information Literature in IMIC1994 ICHE2DEMA Volume9A Web 20104SELIMIC SELIMIC SELIMIC 2 2 GVP SELIMIC ADR; adverse drug reaction AE; adverse event Volume9ASpecial Situations SELIMIC WebJMed Plus ADRAE SELIMIC 3 SELIMIC2 IMIC 1 SELIMICSELIMIC CFR Part11EU GAMP MHRA INSPECTIONIMIC AUDIT AUDIT2SELIMIC IMIC GXP SELIMIC SELIMIC 5 SELIMIC 66(19)
22 SELIMICSOP SELIMIC IMIC IMIC GVP EBM e- SELIMIC SELIMIC 6 GVP SELIMIC INSPECTION 2011 SELIMIC SELIMIC640 4,000 SELIMIC 2012 Volume9A SELIMIC 67(20)
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CONTENTS 01 02-03 04-05 06-07 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 48-49 50-51 52 01 02 Mishima,Michiaki 03 04 05 06 07 09 10 11
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