A decade of cell therapy clinical trials (2000-2010)

Regenerative Medicine

Volumn 7, Issue 4, 2012, Pages 455-462

  Culme Seymour, Emily J ^a   Davie, Natasha L ^b   Brindley, David A ^b   Edwards Parton, Simon ^a   Mason, Chris ^b  

^a London Regenerative Medicine Network   (United Kingdom)

^b UNIVERSITY COLLEGE LONDON   (United Kingdom)

Author keywords

cell therapy; clinical trials; ClinicalTrials.gov; commercialization; regulation; translation

Indexed keywords

ALLOGENEIC STEM CELL TRANSPLANTATION; AUTOLOGOUS STEM CELL TRANSPLANTATION; CLINICAL EFFECTIVENESS; CLINICAL TRIAL (TOPIC); HEALTH CARE INDUSTRY; HUMAN; MANDATORY PROGRAM; MEDICOLEGAL ASPECT; NOTE; PATIENT SAFETY; PRIORITY JOURNAL; STEM CELL RESEARCH; STEM CELL TRANSPLANTATION;

CELL TRANSPLANTATION; CLINICAL TRIALS AS TOPIC; DECISION TREES; HISTORY, 21ST CENTURY; HUMANS;

EID: 84864212396     PISSN: 17460751     EISSN: 1746076X     Source Type: Journal    
DOI: 10.2217/rme.12.45     Document Type: Note

References (19)

1. Cell therapy and regenerative medicine glossary. Regen. Med. 7(3 Suppl.), S1-S124 (2012).
2. Mason C, Brindley DA, Culme-Seymour EJ, Davie NL. Cell therapy industry: Billion dollar global business with unlimited potential. Regen. Med. 6(3), 265-272 (2011).
3. Mason C, Manzotti E. The translation cycle: Round and round in cycles is the only way forward for regenerative medicine. Regen. Med. 5(2), 153-155 (2010).
4. Dimasi JA, Feldman L, Seckler A, Wilson A. Trends in risks associated with new drug development: Success rates for investigational drugs. Clin. Pharmacol. Ther. 87(3), 272-277 (2010).
5. Kaitin KI, Dimasi JA. Pharmaceutical innovation in the 21st century: New drug approvals in the first decade, 2000-2009. Clin. Pharmacol. Ther. 89(2), 183-188 (2011).
6. Arlen PM, Wood LV. Prostate cancer vaccines: Moving therapeutic vaccination forward in the post-Provenge era. Expert Rev. Vaccines 11(3), 287-302 (2012).
7. Ross JS, Mulvey GK, Hines EM, Nissen SE, Krumholz HM. Trial publication after registration in ClinicalTrials.gov: A cross-sectional analysis. PLoS Med. 6(9), e1000144 (2009).
8. Miller JD. Registering clinical trial results: The next step. JAMA 303(8), 773-774 (2010).
9. Allison M. Hemacord approval may foreshadow regulatory creep for HSC therapies. Nat. Biotechnol. 30(4), 304 (2012).
10. Viergever RF, Ghersi D. The quality of registration of clinical trials. PLoS One 6(2), e14701 (2011).
11. Zarin D. Newsmaker interview: DEBORA Zarin. Unseen world of clinical trials emerges from U.S. database. Interview by Eliot Marshall. Science 333(6039), 145 (2011).
12. Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database - update and key issues. N. Engl. J. Med. 364(9), 852-860 (2011).
13. Wyler Von Ballmoos M, Oliveira C. The ClinicalTrials.gov results database. N. Engl. J. Med. 364(22), 2169; author reply 2170 (2011).
14. Magee LA, Menzies J. The ClinicalTrials.gov results database. N. Engl. J. Med. 364(22), 2169; author reply 2170 (2011).
15. Camilleri M. The ClinicalTrials.gov results database. N. Engl. J. Med. 364(22), 2169; author reply 2170 (2011).
16. Viergever RF, Ghersi D. The ClinicalTrials. gov results database. N. Engl. J. Med. 364(22), 2169-2170; author reply 2170 (2011).
17. Dorey E. PERV data renew xeno debate. Nat. Biotechnol. 18(10), 1032-1033 (2000).
18. Mason C, Manzotti E. Regenerative medicine cell therapies: Numbers of units manufactured and patients treated between 1988 and 2010. Regen. Med. 5(3), 307-313 (2010).
19. Maciulaitis R, D'Apote L, Buchanan A, Pioppo L, Schneider CK. Clinical development of advanced therapy medicinal products in Europe: Evidence that regulators must be proactive. Mol. Ther. 20(3), 479-482 (2012).