Skip to main content
SpringerLink
Log in

Regulations/Ethical Guidelines on Human Adult/Mesenchymal Stem Cell Clinical Trial and Clinical Translation

  • Chapter
  • First Online:
Essentials of Mesenchymal Stem Cell Biology and Its Clinical Translation

Abstract

There are two parts in this article. In the first part the authors describe the regulatory and ethical challenges caused by stem cell research and its clinical application, especially by the widespread use of unproven and unregulated “stem cell therapy” and the guidelines and regulations for attempting to deal with challenges in China. At the end of this part ethical guidelines for human adult (including mesenchymal) stem cell clinical trials and application is appended. In the second part the authors try to provide an overview of regulations or ethical guidelines on human adult/mesenchymal stem cell clinical translation in USA, UK, the European countries and India. The article concludes with the harmonization of regulating human adult/mesenchymal stem cell clinical translation in the world and the Guidelines for the Clinical Translation of Stem Cells drafted by the International Society for Stem Cell Research provide a basis for the harmonization.

This is a preview of subscription content, log in via an institution to check access.

Access this chapter

Log in via an institution
Chapter
USD 29.95
Price excludes VAT (USA)
  • Available as PDF
  • Read on any device
  • Instant download
  • Own it forever
eBook
USD 169.00
Price excludes VAT (USA)
  • Available as EPUB and PDF
  • Read on any device
  • Instant download
  • Own it forever
Softcover Book
USD 219.99
Price excludes VAT (USA)
  • Compact, lightweight edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info
Hardcover Book
USD 219.99
Price excludes VAT (USA)
  • Durable hardcover edition
  • Dispatched in 3 to 5 business days
  • Free shipping worldwide - see info

Tax calculation will be finalised at checkout

Purchases are for personal use only

Institutional subscriptions

Notes

  1. 1.

    Please see Legal Information Institute, Cornell University Law School, http://www.law.cornell.edu/cfr/text/21/312.

References

  1. Ahrlund RL, De Luca M, Marshak DR, Munsie M, Veiga A, Rao M. Isolation and production of cells suitable for human therapy: challenges ahead. Cell Stem Cell. 2009;4:20–6.

    Article  Google Scholar 

  2. Ansboro S et al. Strategies for improved targeting of therapeutic cells: implications for tissue repair. Eur Cell Mater. 2012;23:310–9.

    PubMed  CAS  Google Scholar 

  3. Bellamy J. Stem cell therapy regulation plays catch up. Science-Based Medicine, August 9, 2012.

    Google Scholar 

  4. Bersenev A. Regulation of autologous adult stem cells – the case of regulatory regress. Cell Trials, October 18. http://celltrials.info/2012/10/18/regulation-autologous-adult-stem-cells-case-regulatory-regress/ (2012).

  5. Bianco P, Robey PG, Robey PJ. Mesenchymal stem cells: revisiting history, concepts, and assays. Cell Stem Cell. 2008;2:313–9.

    Article  PubMed  CAS  Google Scholar 

  6. Bieback K, Kinzebach S, Karagianni M. Translating research into clinical scale manufacturing of mesenchymal stromal cells. Stem Cells Int. 2010;25:1–11.

    Article  Google Scholar 

  7. Catalano J. The international conference on harmonization (ICH) and its relevance to cell therapy. In: ISCT 6th annual somatic cell therapy symposium. 2. Available from: http://www.fda.gov/cber/genetherapy/isct092506jc.htm (2006).

  8. Collins NH. Product review, release, and administration. In: Gee A, editor. Cell therapy: cGMP facilities and manufacturing. New York: Springer; 2009. p. 215–28.

    Google Scholar 

  9. EU Directive 2001/20/EC. Relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Official J Eur Commun, 1 May 2001.

    Google Scholar 

  10. EU Directive 2001/83/EC. The community code relating to medicinal products for human use. http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004481.pdf

  11. EU Directive 2003/63/EC. Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official J Eur Union, 27 June 2003.

    Google Scholar 

  12. EU Directive 2004/23/EC. Setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2004:102:0048:0058:en:PDF

  13. Dresser R, Frader J. Off-label prescribing: a call for heightened professional and government oversight. J Law Med Ethics. 2009;37:476–86.

    Article  PubMed  Google Scholar 

  14. Editorial 2012. Stem cell research: regulating translational application. Nat Cell Biol. 14557, published online 30 May 2012.

    Google Scholar 

  15. EU EMEA. Guideline on human cell-based medicinal products. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003894.pdf (2008).

  16. EU CAT. Reflection paper on stem cell-based medicinal products. EMA/CAT/571134/2009, 2011;1–14. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2011/02/WC500101692.pdf.

  17. EU Committee for Advanced Therapies (CAT). Use of unregulated stem-cell based medicinal products. Lancet. 2010;376:514.

    Article  Google Scholar 

  18. EU European Medicines Agency (EMEA). Guideline on strategies to identify and mitigate risks for first-in-human clinical trials with investigational medicinal products, Doc. Ref.EMEA/CHMP/SWP/28367/07. http://www.emea.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500002988.pdf (2007).

  19. EU Regulation 1394/2007/EC. On advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. Official J Eur Comm, 10 Dec 2007.

    Google Scholar 

  20. Gatti RA, Meuwissen HJ, Allen HD, Hong R, Good RA. Immunological reconstitution of sex-linked lymphopenic immunological deficiency. Lancet. 1968;2:1366–9.

    Article  PubMed  CAS  Google Scholar 

  21. Gee A. Mesenchymal stem-cell therapy in a regulated environment. Cytotherapy. 2001;3:397–8.

    Article  PubMed  CAS  Google Scholar 

  22. George B. Regulations and guidelines governing stem cell based products: clinical considerations. Perspect Clin Res. 2011;2(3):94–9, Jul–Sep.

    Article  PubMed  Google Scholar 

  23. Halme DG, Kessler DA. FDA regulation of stem-cell based therapies. N Engl J Med. 2006;355:1730–5.

    Article  PubMed  CAS  Google Scholar 

  24. Hyun I. Allowing innovative stem cell-based therapies outside of clinical trials: ethical and policy challenges. J Law Med Ethics. 2010;38:277–85.

    Article  PubMed  Google Scholar 

  25. Indian CDSCO. Guidance for industry on submission of clinical trial application for evaluating safety and efficacy. Doc No. CT/71108, Version 1.1, 2008. Available from: http://www.cdsco.nic.in (2008).

  26. Indian Council of Medical Research (ICMR). Ethical guidelines for biomedical research on human subjects. http://icmr.nic.in/ethical_guidelines.pdf (2006).

  27. Indian Council of Medical Research. National guidelines on stem cell research and therapy. http://www.inclentrust.org/uploadedbyfck/file/2007.pdf (2007).

  28. International Society for Stem Cell Research (ISSCR). Guidelines for the clinical translation of stem cells. Available from: http://www.isscr.org/clinical_trans/index.cfm (2008).

  29. Koleva G. Stem cells, FDA, and the edge of science: three expert viewpoints, Forbes 2/19/2012. http://www.forbes.com/sites/gerganakoleva/2012/02/19/stem-cells-fda-and-the-edge-of-science-three-expert-viewpoints/ (2012).

  30. Leanne B, Sarah D. Gaps and overlaps: improving the current regulation of stem cells in the UK. J Med Ethics. 2007;33:621–2.

    Article  Google Scholar 

  31. Lelas A. Future research and therapeutic applications of human stem cells: general, regulatory, and bioethical aspects. J Transl Med. 2010;8:131.

    Article  PubMed  Google Scholar 

  32. Martell K, Trounson A, Baum E. Stem cell therapies in clinical trials: workshop on best practices and the need for harmonization. Cell Stem Cell. 2010;7:451–4.

    Article  PubMed  CAS  Google Scholar 

  33. Parson A. The long journey from stem cells to medical product. Cell. 2006;125:9–11.

    Article  PubMed  CAS  Google Scholar 

  34. Rayment EA, Williams DJ. Concise review: mind the gap: challenges in characterizing and quantifying cell- and tissue-based therapies for clinical translation. Stem Cells. 2010;28:996–1004.

    PubMed  Google Scholar 

  35. Shapiro J, et al. FDA’s regulatory scheme for human tissue: a brief overview. Hum Tissue Regul, Update, p. 10 with permission from FDLI, www.fdli.com (2007).

  36. Stemedica. Current News Release, October 2. http://www.stemedica.com/info/allogeneic-adult-stem-cells/stem-cell-clinical-trials/2012-1002-FDA-Approves-Stemedica-Phase-II-Clinical-Trial-Acute-Myocardial-Infarction-Ischemia-Tolerant-Mesenchymal-Stem-Cells.asp (2012).

  37. The Hinxton Group. An international consortium on stem cells, ethics and law. Law Hum Genome Rev. 2006;24:251–5.

    Google Scholar 

  38. UK Medical Research Council (MRC). Code of practice for the use of human stem cell lines, April 2010. http://www.mrc.ac.uk/Utilities/Documentrecord/index.htm?d=MRC003132 (2010).

  39. US FDA. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license; correction – FDA. Proposed rule; correction. Fed Regist. Sept 2, 1998a;63(170):46718.

  40. US FDA. Guidance for human somatic cell therapy and gene therapy, FDA Center for Biologics Evaluation and Research. http://www.fda.gov/biologicsbloodvaccines/guidancecomplianceregulatoryinformation/guidances/cellularandgenetherapy/ucm072987.htm (1998b).

  41. US FDA Human cells, tissues and cellular and tissue-based products, Code of Federal Regulations Title 21 Part 1271. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=1271 (2006).

  42. US Food and Drug Administration (FDA). Proposed approach to regulation of cellular and tissue-based products. The Food and Drug Administration. http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Tissue/UCM062601.pdf (1997).

Download references

Author information

Authors and Affiliations

  1. Center for Bioethics, Chinese Academy of Medical Sciences/Peking Union Medical College, Beijing, China

    Xiaomei Zhai (Professor and Director) & Renzong Qiu (Professor and Chair of the Academic Committee)

Authors
  1. Xiaomei Zhai
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Renzong Qiu
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Xiaomei Zhai .

Editor information

Editors and Affiliations

  1. Chinese Academy of Medical Sciences and Peking Union Medical College, Center of Excellence in Tissue Engineering, Institute of Basic Medical Sciences and School of Basic Medicine, 5 Dong Dan San Tiao, Beijing, 100005, China, People's Republic

    Robert Chunhua Zhao

Rights and permissions

Reprints and permissions

Copyright information

© 2013 Springer Science+Business Media Dordrecht

About this chapter

Cite this chapter

Zhai, X., Qiu, R. (2013). Regulations/Ethical Guidelines on Human Adult/Mesenchymal Stem Cell Clinical Trial and Clinical Translation. In: Zhao, R. (eds) Essentials of Mesenchymal Stem Cell Biology and Its Clinical Translation. Springer, Dordrecht. https://doi.org/10.1007/978-94-007-6716-4_19

Download citation

Publish with us

Policies and ethics

Search

Navigation