Translating stem cell research to the clinic: A primer on translational considerations for your first stem cell protocol

Stem Cell Research and Therapy

Volumn 6, Issue 1, 2015, Pages

  O'Brien, Timothy ^a   Creane, Michael ^a   Windebank, Anthony J ^b   Terzic, Andre ^b   Dietz, Allan B ^b  

^a NATIONAL UNIVERSITY OF IRELAND   (Ireland)

^b MAYO CLINIC   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

HUMAN; PROCEDURES; STEM CELL RESEARCH; TRANSLATIONAL RESEARCH;

HUMANS; STEM CELL RESEARCH; TRANSLATIONAL MEDICAL RESEARCH;

EID: 84939808899     PISSN: None     EISSN: 17576512     Source Type: Journal    
DOI: 10.1186/s13287-015-0145-7     Document Type: Review

References (11)

1. Davison AC. Brave pioneers or clinical cowboys? Cell Stem Cell. 2010;6:504-5.
2. 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.
3. Bravery CA, Carmen J, Fong T, Oprea W, Hoogendoorn KH, Woda J, et al. Potency assay development for cellular therapy products: an ISCTa∗ - review of the requirements and experiences in the industry. Cytotherapy. 2013;15:9-19. e19.
4. Frey-Vasconcells J, Whittlesey KJ, Baum E, Feigal EG. Translation of stem cell research: points to consider in designing preclinical animal studies. Stem Cells Transl Med. 2012;1:353-8.
5. Au P, Hursh DA, Lim A, Moos Jr MC, Oh SS, Schneider BS, et al. FDA oversight of cell therapy clinical trials. Sci Transl Med. 2012;4:149fs31.
6. Bravery CA, French A. Reference materials for cellular therapeutics. Cytotherapy. 2014;16:1187-96.
7. Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8:315-7.
8. 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.
9. 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.
10. 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.
11. von Bahr L, Batsis I, Moll G, Hägg M, Szakos A, Sundberg B, et al. Analysis of tissues following mesenchymal stromal cell therapy in humans indicates limited long-term engraftment and no ectopic tissue formation. Stem Cells. 2012;30:1575-8.