Perspectives developing induced pluripotent stem cell-based therapy for the masses

Stem Cells Translational Medicine

Volumn 5, Issue 2, 2016, Pages 129-131

  Rao, Mahendra S ^a,b   Atala, Anthony ^b  

^a Q Therapeutics   (United States)

^b WAKE FOREST SCHOOL OF MEDICINE   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BLOOD BANK; CELL THERAPY; HUMAN; PLURIPOTENT STEM CELL; REGENERATIVE MEDICINE; SAFETY; UMBILICAL CORD BLOOD; COST BENEFIT ANALYSIS; ECONOMICS; FETUS BLOOD; FOOD AND DRUG ADMINISTRATION; INDUCED PLURIPOTENT STEM CELL; LEGISLATION AND JURISPRUDENCE; POSTMARKETING SURVEILLANCE; PROCEDURES; STEM CELL TRANSPLANTATION; TRANSPLANTATION; UNITED STATES;

BLOOD BANKS; COST-BENEFIT ANALYSIS; FETAL BLOOD; HUMANS; INDUCED PLURIPOTENT STEM CELLS; PRODUCT SURVEILLANCE, POSTMARKETING; REGENERATIVE MEDICINE; STEM CELL TRANSPLANTATION; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84970935832     PISSN: 21576564     EISSN: 21576580     Source Type: Journal    
DOI: 10.5966/sctm.2015-0184     Document Type: Article

References (13)

1. Available at http://stemcellassays.com/2012/11/notable-market-approvals-2012/.Accessed November 15, 2015.
2. Available at http://stemcellassays.com/2011/07/notable-approvals-regenerative-medicine/.Accessed November 15, 2015.
3. Available at http://www.fda.gov/BiologicsBloodVaccines/DevelopmentApprovalProcess/BiologicsLicenseApplicationsBLA Process/default.htm.AccessedNovember 15, 2015.
4. Rao MS. LULL(ed) into complacency: A perspective on licenses and stem cell translational science. Stem Cell Res Ther 2013;4:98. www.StemCellsTM.com
5. Available at http://www.ipscell.com/2015/07/takahashi_cea/.Accessed November 15, 2015.
6. Malik N, Rao MS. A review of the methods for human iPSC derivation. Methods Mol Biol 2013;997:23-33.
7. Skowron K, Tomsia M, Czekaj P. An experimental approach to the generation of human embryonic stem cells equivalents. Mol Biotechnol 2014;56:12-37.
8. Available at http://parentsguidecordblood. org/accreditation.php.Accessed November 15, 2015.
9. Kurtzberg J, Prasad VK, Carter SL et al. Results of the Cord Blood Transplantation Study (COBLT): Clinical outcomes of unrelated donor umbilical cord blood transplantation ipediatric patients with hematologic malignancies. Blood 2008;112:4318-4327.
10. Available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/PremarketSubmissions/PremarketApprovalPMA/ucm142714.htm.Accessed November 15, 2015.
11. Van Wilder P. Advanced therapy medicinal products and exemptions to the regulation 1394/2007: How confident can we be? An exploratory analysis. Front Pharmacol 2012;3:12.
12. Carpenter MK, Rao MS. Making and using clinically compliant pluripotent stem cell lines. Stem Cells Transl Med 2015;4:381-388.
13. Turner M, Leslie S, Martin NG et al. Toward the development of a global induced pluripotent stem cell library. Cell Stem Cell 2013;13:382-384.