Autologous cell therapies: Challenges in US FDA regulation

Regenerative Medicine

Volumn 7, Issue 6 SUPPL., 2012, Pages 94-97

  McAllister, Todd N ^a   Audley, David ^a   L'Heureux, Nicolas ^a  

^a Cytograft Tissue Engineering Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ACCREDITATION; AUTOLOGOUS STEM CELL TRANSPLANTATION; CLINICAL EFFECTIVENESS; COST CONTROL; FUNDING; GOOD MANUFACTURING PRACTICE; HEALTH CARE COST; HUMAN; MEDICAL ETHICS; NONHUMAN; PATIENT CARE; PATIENT SAFETY; PRIORITY JOURNAL; QUALITY CONTROL; REGENERATIVE MEDICINE; REVIEW; RISK ASSESSMENT; RISK BENEFIT ANALYSIS; UNITED STATES;

DRUG INDUSTRY; HUMANS; SOCIAL CONTROL, FORMAL; TISSUE THERAPY; TRANSPLANTATION, AUTOLOGOUS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84870721525     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.12.83     Document Type: Review

References (25)

1. Lysaght, MJ Hazlehurst AL. Tissue engineering: the end of the beginning. Tissue Eng. 10(1-2), 309-320 (2004).
2. Lysaght MJ, Jaklenec A, Deweerd E. Great expectations: private sector activity in tissue engineering, regenerative medicine, and stem cell therapeutics. Tissue Eng. Part A 14(2), 305-315 (2008).
3. Jaklenec A, Stamp A, Deweerd E, Sherwin A, Langer R. Progress in the tissue engineering and stem cell industry "are we there yet?". Tissue Eng. Part B Rev. 18(3), 155-166 (2012).
4. Frantz S. Embryonic stem cell pioneer Geron exits field, cuts losses. Nat. Biotechnol. 30(1), 12-13 (2012).
5. Makower J, Meer A, Denend L. FDA Impact on U.S. Medical Technology Innovation: A Survey of Over 200 Medical Technology Companies. National Venture Capital Association, Arlington, VA, USA (2010).
6. Gottlieb S. How the FDA could cost you your life. Wall Street Journal 3 October (2011).
7. Topol EJ. Failing the public health - rofecoxib, Merck, and the FDA. N. Engl. J. Med. 351(17), 1707-1709 (2004).
8. Silicone breast implants: lessons from the USA. Lancet 379(9811), 93 (2012).
9. Coon SK, Burris R, Coleman EA, Lemon SJ. An analysis of telephone interview data collected in 1992 from 820 women who reported problems with their breast implants to the food and drug administration. Plast. Reconstr. Surg. 109(6), 2043-2051 (2002).
10. Amariglio N, Hirshberg A, Scheithauer BW et al. Donor-derived brain tumor following neural stem cell transplantation in an ataxia telangiectasia patient. PLoS Med. 6(2), e1000029 (2009).
11. Barclay E. Stem-cell experts raise concerns about medical tourism. Lancet 373(9667), 883-884 (2009).
12. Cyranoski D. Korean deaths spark inquiry. Nature 468(7323), 485 (2010).
13. Cyranoski D. FDA challenges stem-cell clinic. Nature 466(7309), 909 (2010).
14. Cyranoski D. FDA's claims over stem cells upheld. Nature 488(14) (2012).
15. Gottlieb S, Klasmeier C. The FDA wants to regulate your cells. Wall Street Journal 7 August (2012).
16. Philippidis A. Stem cell tourism hardly a vacation. Genetic Engineering & Biotechnology News, 16th August (2012).
17. Lerner M. Clinic taps patients' own stem cells to ease their pain. Star Tribune 13 August (2012).
18. Roger VL, Go AS, Lloyd-Jones DM et al. Executive summary: heart disease and stroke statistics - 2012 update: a report from the American Heart Association. Circulation 125(1), 188-197 (2012)
19. Quigley MM, Andrews LB. Human in vitro fertilization and the law. Fertil. Steril. 42(3), 348-355 (1984).
20. Medical Tourism Statistics & Facts. www.patientsbeyondborders.com/ medicaltourism- statistics-facts
21. The rise of medical tourism http://grailresearch.com/pdf/ContenPodsPdf/ Rise-of-Medical- Tourism-Summary.pdf
22. Malarkey MA. FDA warning letter to IntelliCell Biosciences. www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm297245.htm (Accessed 23 August 2012).
23. Malarkey MA. FDA warning letter to Thomas E Young LLC. www.fda.gov/ICECI/EnforcementActions/WarningLetters/2012/ucm301620.htm (Accessed 23 August 2012).
24. ISSCR emphasizes rigorous oversight for application of stem cell based treatments. www.isscr.org/ISSCR-emphasizes- rigorous-oversight-for-application- of- stem-cell-based-treatments/4573.htm (Accessed 23 August 2012).
25. Pelley S. 60 minutes: stem cell fraud. 9 January (2012). www.cbsnews.com/video/watch/?id=7394380n (Accessed 24 August 2012).