Advertisement

Stem Cell Reviews and Reports

, Volume 8, Issue 3, pp 623–628 | Cite as

Regulation of Stem Cell-Based Therapies in Canada: Current Issues and Concerns

  • Barbara von Tigerstrom
  • Thu Minh Nguyen
  • Bartha Maria Knoppers
Article

Abstract

Stem cell therapies offer enormous potential for the treatment of a wide range of diseases and conditions. Despite the excitement over such advances, regulators are faced with the challenge of determining criteria to ensure stem cells and their products are safe and effective for human use. However, stem cell-based products and therapies present unique regulatory challenges because standard drug development models do not wholly apply given the complexity and diversity of these products and therapies. As a result, regulatory requirements are often unclear and ambiguous creating unnecessary barriers for research. In order to better understand the barriers that might affect Canadian stem cell researchers, we sought feedback from stakeholders regarding areas of uncertainty or concern about existing regulatory oversight of cell therapies. A selection of Canadian researchers and clinicians working in the area of stem cell research were interviewed to assess certain key questions: 1) whether current regulatory requirements are easily accessible and well understood; 2) whether regulatory requirements create important challenges or barriers; and 3) whether there is a need for further guidance on the issue. The results of this survey are summarized and compared to issues and concerns experienced in other countries, as reported in the literature, to identify challenges which may be on the horizon and to provide possible solutions for regulatory reform.

Keywords

Stem cell-based therapies Stem cell-based products Law Policy 

Notes

Acknowledgements

The authors would like to thank the Canadian Stem Cell Network and ThéCell: le réseau de thérapie cellulaire et tissulaire for their funding support, and Adryan Toth (LL.M. candidate, University of Saskatchewan) for his assistance with research on this project.

Conflict of interest statement

The authors declare no potential conflicts of interest.

References

  1. 1.
    Plagnol, A. C., Rowley, E., Martin, P., & Livesey, F. (2009). Industry perceptions of barriers to commercialization of regenerative medicine products in the UK. Regenerative Medicine, 4(4), 549–559.PubMedCrossRefGoogle Scholar
  2. 2.
    Ginty, P. J., Rayment, E. A., Hourd, P., & Williams, D. J. (2011). Regenerative medicine, resource and regulation: lessons learned from the remedy project. Regenerative Medicine, 6(2), 241–253.PubMedCrossRefGoogle Scholar
  3. 3.
    Geron Corporation (2011). Geron to focus on its novel cancer programs. News Release Document. http://www.geron.com/media/pressview.aspx?id=1284. Accessed 23 December 2011.
  4. 4.
    Brévignon-Dodin, L. (2009). Regulation as an enabler for emerging industries. Literature review. Centre for Industry and Government. http://www.ifm.eng.cam.ac.uk/cig/documents/0902cig_working_paper.pdf. Accessed 23 December 2011.
  5. 5.
    Martell, K., Trouson, A., & Baum, E. (2010). Stem cell therapies in clinical trials: workshop on best practices and the need for harmonization. Cell Stem Cell, 7, 451–454.PubMedCrossRefGoogle Scholar
  6. 6.
    Johnson, P. C., Bertram, T. A., Tawil, B., & Hellman, K. B. (2011). Hurdles in tissue engineering/regenerative medicine product commercialization: a survey of North American academia and industry. Tissue Engineering, 17(Part A), 5–15.PubMedGoogle Scholar
  7. 7.
    Food and Drugs Act (1985). R.S.C., c F-27.Google Scholar
  8. 8.
    Von Tigerstrom, B., & Schroh, E. (2007). Regulation of stem cell-based products. Health Law Journal, 15, 175–220.Google Scholar
  9. 9.
    Nguyen, T. M., Von Tigerstrom, B., Knoppers, B. M. (2011). Regulatory framework for the development of stem cell-based therapies. Stem Cell Ethics Education (website). http://www.stemcellethics.ca/sites/default/files/roadmap_june_2011.pdf.
  10. 10.
    Food and Drug Regulations, C.R.C., c. 870.Google Scholar
  11. 11.
    Medical Devices Regulations (1998). SOR/98-282.Google Scholar
  12. 12.
    Safety of Human Cells, Tissues and Organs for Transplantation Regulations (2007). SOR/2007-118.Google Scholar
  13. 13.
    Assisted Human Reproduction Act (2004). S.C., c. 2.Google Scholar
  14. 14.
    Reference re Assisted Human Reproduction Act (2010). SCC 61, [2010] 3 S.C.R. 457.Google Scholar
  15. 15.
    Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council of Canada, Social Sciences and Humanities Research Council of Canada. Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (2010). http://www.pre.ethics.gc.ca/pdf/eng/tcps2/TCPS_2_FINAL_Web.pdf. Accessed 23 December 2011.
  16. 16.
    Canadian Institutes of Health Research (2010). Updated guidelines for human pluripotent stem cell research, http://www.cihr-irsc.gc.ca/e/42071.html. Accessed 23 December 2011.
  17. 17.
    Tsang, L. (2005). Legal and ethical status of stem cells as medicinal products. Advanced Drug Delivery Reviews, 57, 1970.PubMedCrossRefGoogle Scholar
  18. 18.
    Bravery, C. (2010). Regulating interface science healthcare products: myths and uncertainties. Journal of the Royal Society Interface, 7, S789–S795.CrossRefGoogle Scholar
  19. 19.
    Fink, D. W. (2009). FDA regulation of stem cell-based products. Science, 324(5935), 1662–1663.PubMedCrossRefGoogle Scholar
  20. 20.
    Kimmelman, J., Baylis, F., & Glass, K. (2006). Stem cell trials: lessons from gene transfer research. Hastings Center Report, 36(1), 23–26.PubMedCrossRefGoogle Scholar
  21. 21.
    Zarzeczny, A., Scott, C., Hyun, I., et al. (2009). iPS cells: mapping the policy issues. Cell, 136(6), 1032–1037.CrossRefGoogle Scholar
  22. 22.
    Messenger, M. P., & Tomlins, P. E. (2011). Regenerative medicine: a snapshot of the current regulatory environment and standards. Advanced Materials, 23, H10–H17.PubMedCrossRefGoogle Scholar
  23. 23.
    Strauss, S. (2010). Geron trial resumes, but standards for stem cell trials remain elusive. Nature Biotechnology, 28, 989–990.PubMedCrossRefGoogle Scholar
  24. 24.
    Preti, R. A. (2005). Bringing safe and effective cell therapies to the bedside. Nature Biotechnology, 23(7), 801–804.PubMedCrossRefGoogle Scholar
  25. 25.
    Then, S.-N. (2009). Regulation of stem cell research in Australia. Stem Cell Reviews and Reports, 5(1), 1–5.PubMedCrossRefGoogle Scholar
  26. 26.
    Fox, J. L. (2011). Human iPSC and ESC translation potential debated. Nature Biotechnology, 29, 375–376.PubMedCrossRefGoogle Scholar
  27. 27.
    Carpenter, M. K., & Couture, L. A. (2010). Regulatory considerations for the development of autologous induced pluripotent stem cell therapies. Regenerative Medicine, 5(4), 569–579.PubMedCrossRefGoogle Scholar
  28. 28.
    Bravery, C. (2010). Regulating interface science healthcare products: myths and uncertainties. Journal of the Royal Society Interface, 7, S789–S795.CrossRefGoogle Scholar
  29. 29.
    Osborne, R. (2009). US regulator wades into stem cell therapies for heart disease. Nature Biotechnology, 27(6), 496–498.PubMedCrossRefGoogle Scholar
  30. 30.
    Bell, L., & Devaney, S. (2007). Gaps and overlaps: improving the current regulation of stem cells in the UK. Journal of Medical Ethics, 4, 549–559.Google Scholar
  31. 31.
    Daniels, J. T., Secker, G. A., Shortt, A. J., Tuft, S. J., & Seetharaman, S. (2006). Stem cell therapy delivery: treading the regulatory tightrope. Regenerative Medicine, 5(1), 715–719.CrossRefGoogle Scholar
  32. 32.
    Nerem, R. M. (2010). Regenerative medicine: the emergence of an industry. Journal of the Royal Society Interface, 7(Suppl. 6), S771–S775.CrossRefGoogle Scholar
  33. 33.
    Evans, A. (2011). Obtaining manufacturing approval for the first culture-expanded adult stem cell therapy under an evolving regulatory framework: Challenges and opportunities. International Society for Cellular Therapy 17th Annual Meeting. Poster Presentation. http://celltherapies.com.au/Alannah_Poster_ISCT_2011portrait.pdf. Accessed 23 December 2011.
  34. 34.
    Menasche, P. (2010). Cardiac cell therapy: lessons from clinical trials. Journal of Molecular and Cellular Cardiology, 5(2), 258–265.Google Scholar
  35. 35.
    Polak, J. M., & Bishop, A. E. (2006). Stem cells and tissue engineering: past, present, and future. Annals of the New York Academy of Sciences, 1068, 352–366.PubMedCrossRefGoogle Scholar
  36. 36.
    Regulation (EC) No. 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2007_1394/reg_2007_1394_en.pdf. Accessed 23 December 2011.
  37. 37.
    Centre for Commercialization of Regenerative Medicine (2011). Executive summary. http://www.ccrm.ca/sites/default/files/CCRM%20Executive%20Summary_0.pdf. Accessed 3 January 2011.
  38. 38.
    Kent, D. (2011). Not all doom and gloom: Major investment in UK stem cell therapy initiative. Stem Cell Network. Blog. http://scnblog.typepad.com/scnblog/2011/11/not-all-doom-and-gloom-major-investment-in-uk-stem-cell-therapy-initiative-.html. Accessed 23 December 2011.

Copyright information

© Springer Science+Business Media, LLC 2012

Authors and Affiliations

  • Barbara von Tigerstrom
    • 1
  • Thu Minh Nguyen
    • 2
  • Bartha Maria Knoppers
    • 2
  1. 1.University of SaskatchewanSaskatoonCanada
  2. 2.McGill UniversityMontrealCanada

Personalised recommendations