TY - JOUR AU - Davison, A. C. PY - 2010 DA - 2010// TI - Brave pioneers or clinical cowboys? JO - Cell Stem Cell. VL - 6 UR - https://doi.org/10.1016/j.stem.2010.05.011 DO - 10.1016/j.stem.2010.05.011 ID - Davison2010 ER - TY - STD TI - US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, CGMP for Phase 1 Investigational Drugs. 2008. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/uuc070273.pdf. Accessed 19 May 2014. UR - http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/uuc070273.pdf ID - ref2 ER - TY - JOUR AU - Bravery, C. A. AU - Carmen, J. AU - Fong, T. AU - Oprea, W. AU - Hoogendoorn, K. H. AU - Woda, J. PY - 2013 DA - 2013// TI - Potency assay development for cellular therapy products: an ISCT∗ review of the requirements and experiences in the industry JO - Cytotherapy VL - 15 UR - https://doi.org/10.1016/j.jcyt.2012.10.008 DO - 10.1016/j.jcyt.2012.10.008 ID - Bravery2013 ER - TY - JOUR AU - Frey-Vasconcells, J. AU - Whittlesey, K. J. AU - Baum, E. AU - Feigal, E. G. PY - 2012 DA - 2012// TI - Translation of stem cell research: points to consider in designing preclinical animal studies JO - Stem Cells Transl Med. VL - 1 UR - https://doi.org/10.5966/sctm.2012-0018 DO - 10.5966/sctm.2012-0018 ID - Frey-Vasconcells2012 ER - TY - JOUR AU - Au, P. AU - Hursh, D. A. AU - Lim, A. AU - Moos, M. C. AU - Oh, S. S. AU - Schneider, B. S. PY - 2012 DA - 2012// TI - FDA oversight of cell therapy clinical trials JO - Sci Transl Med VL - 4 UR - https://doi.org/10.1126/scitranslmed.3004131 DO - 10.1126/scitranslmed.3004131 ID - Au2012 ER - TY - JOUR AU - Bravery, C. A. AU - French, A. PY - 2014 DA - 2014// TI - Reference materials for cellular therapeutics JO - Cytotherapy. VL - 16 UR - https://doi.org/10.1016/j.jcyt.2014.05.024 DO - 10.1016/j.jcyt.2014.05.024 ID - Bravery2014 ER - TY - JOUR AU - Dominici, M. AU - Blanc, K. AU - Mueller, I. AU - Slaper-Cortenbach, I. AU - Marini, F. AU - Krause, D. PY - 2006 DA - 2006// TI - Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement JO - Cytotherapy VL - 8 UR - https://doi.org/10.1080/14653240600855905 DO - 10.1080/14653240600855905 ID - Dominici2006 ER - TY - STD TI - US Department of Health and Human Services, Food and Drug Administration. Good Laboratory Practices for Nonclinical Laboratory Studies. 2013. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58&showfr=1. Accessed May 19, 2014. UR - http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=58&showfr=1 ID - ref8 ER - TY - STD TI - US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Preclinical Assessment of Investigational Cellular and Gene Therapy Products. 2013. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM376521.pdf. Accessed May 19, 2014. UR - http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/CellularandGeneTherapy/UCM376521.pdf ID - ref9 ER - TY - STD TI - US Department of Health and Human Services, Food and Drug Administration. Guidance for Industry, Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products. 2013. http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm359073.pdf. Accessed May 19, 2014. UR - http://www.fda.gov/downloads/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm359073.pdf ID - ref10 ER - TY - JOUR AU - Bahr, L. AU - Batsis, I. AU - Moll, G. AU - Hägg, M. AU - Szakos, A. AU - Sundberg, B. PY - 2012 DA - 2012// TI - Analysis of tissues following mesenchymal stromal cell therapy in humans indicates limited long-term engraftment and no ectopic tissue formation JO - Stem Cells. VL - 30 UR - https://doi.org/10.1002/stem.1118 DO - 10.1002/stem.1118 ID - Bahr2012 ER -