Resources

Reports and Peer-Reviewed Publications

Atala, Anthony and Julie Allickson. Translational Regenerative Medicine. 2014. Accessed at: https://www.elsevier.com/books/translational-regenerative-medicine/atala/978-0-12-410396-2.

Bipartisan Policy Center. (2015). “Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans.” Accessed at: http://bipartisanpolicy.org/wp-content/uploads/2015/12/BPC-Advancing-Regenerative-Cellular-Therapies.pdf.

California Institute for Regenerative Medicine. (2014).  “2014 Annual Report.” Accessed at: https://www.cirm.ca.gov/sites/default/files/files/about_cirm/4.cirm_.brochure.AR_.2014.fp1_.singlepages.pdf.

California Institute for Regenerative Medicine. (2014). “Proceedings: International Regulatory Considerations on Development Pathways for Cell Therapies.” Accessed at: https://www.cirm.ca.gov/sites/default/files/files/about_cirm/Converted%20article.pdf.

Caplan, Arnold I. “Legislation for today’s cell and tissue based therapies.” CellR4 4 (2): e1804. (2016). Accessed at: http://www.cellr4.org/wp-content/uploads/2016/03/CellR4-2016-4-2-e1804.pdf.

Caplan, Arnold I., and Michael D. West. “Progressive Approval: A Proposal for a New Regulatory Pathway for Regenerative Medicine.” Stem Cells Translational Medicine 3 (5): 560-563. (2014). Accessed at: http://www.ncbi.nlm.nih.gov/pubmed/24682285

Chirba, Mary Ann, and Stephanie M. Garfield. “FDA Oversight of Autologous Stem Cell Therapies: Legitimate Regulation of Drugs and Devices or Groundless Interference with the Practice of Medicine?” Journal of Health & Biomedical Law, 7 (2): 233-272, (2011). Accessed at: http://www.suffolk.edu/documents/Law%20Journal%20of%20H%20and%20B/c_Chirba_233-272.pdf.

Japan Ministry of Health, Labour and Welfare. Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013). http://www.mhlw.go.jp/english/policy/health-medical/pharmaceuticals/dl/150407-01.pdf.

JCR Pharmaceuticals Co. (2015). “JCR Receives Approval for TEMCELL® HS Inj., The First Allogeneic Regenerative Medicine in Japan.” Accessed at: http://www.jcrpharm.co.jp/en/site/en/ir/pdf/ir_news_20150918.pdf.

Kiernan, Jeffrey, Sally Hu, Marc D. Grynpas, John E. Davies, and William L. Stanford. Systemic MSC transplantation prevents functional bone loss in a mouse model of age-related osteoporosis.” Stem Cells Translational Medicine 3 (5): 1-11. (2016). Accessed at: http://stemcellstm.alphamedpress.org/content/early/2016/03/15/sctm.2015-0231.full.pdf.

Pharmaceuticals and Medical Devices Agency. (2015). “ACTO Satellite Symposium: Japanese Regulation of Regenerative Medicine.” Accessed at: http://www.pmda.go.jp/files/000199507.pdf.

Reisman, Miriam and Katherine T. Adams. “Stem Cell Therapy: a Look at Current Research, Regulations, and Remaining Hurdles.” Pharmacy and Therapeutics, (2014); 39(12): 846-847, 854-857. Accessed at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4264671/.

Slabiak, Trina. “Stem Cell-based Therapies and FDA Regulations.” Regulatory Focus, (2012). http://www.raps.org/regulatoryDetail.aspx?id=7734.

Terzic, Andre, Michael A. Pfenning, Gregory J. Gores, and C. Michel Harper Jr. “Regenerative Medicine Build-Out.” Stem Cells Translational Medicine, 4 (12): 1373-1379. (2015). Accessed at: http://stemcellstm.alphamedpress.org/content/4/12/1373.full.pdf+html.

Trounson, Alan, Courtney McDonald. “Stem Cell Therapies in Clinical Trials: Progress and Challenges.” Cell Stem Cell 17 (1): 11-22. (2015). Accessed at: http://www.cell.com/cell-stem-cell/abstract/S1934-5909(15)00267-2.

von Tigerstrom, Barbara. “Revising the Regulation of Stem Cell‑Based Therapies: Critical Assessment of Potential Models.” Food and Drug Law Journal (2015). Accessed at: https://www.researchgate.net/publication/279885936_Revising_the_Regulation_of_Stem_Cell-Based_Therapies_Critical_Assessment_of_Potential_Models.

News Articles:

Atala, Anthony. “Study Shows How Stem Cells Might Restore Bones Damaged by Osteoporosis.” Stem Cells Portal, (2016). Accessed at: http://stemcellsportal.com/Study-Shows-How-Stem-Cells-Might-Restore-Bones-Damaged-by-Osteoporosis#sthash.Gg5LDK22.dpuf.

Binsted, Tim. “Mesoblast stem cell therapy approved by Japanese health watchdog.” Syndey Morning Herald, (September 2015). Accessed at: http://www.smh.com.au/business/mesoblast-stem-cell-therapy-approved-by-japanese-health-watchdog-20150918-gjpy1v.html.

Cyranoski, David. “China announces stem-cell rules.” Nature, (2015). Accessed at: http://www.nature.com/news/china-announces-stem-cell-rules-1.18252.

deBruyn, Jason. “Duke receives $15M to study potential autism treatment using umbilical cord blood.” Triangle Business Journal, (June 2014). Accessed at: http://www.bizjournals.com/triangle/news/2014/06/18/duke-receives-15m-to-study-potential-autism.html.

Frist, William H. and Bart Gordon. “Time to pass medical innovation legislation.” The Hill, (February 2016). Accessed at: http://thehill.com/blogs/congress-blog/healthcare/269151-time-to-pass-medical-innovation-legislation.

Grant, Bob “CIRM Ups Translational Velocity.” The Scientist, (December 2015). Accessed at: http://www.the-scientist.com/?articles.view/articleNo/44887/title/CIRM-Ups-Translational-Velocity/.

Greenfield, Beth. “How Cord Blood Turned This 4-Year-Old’s Life Around.” Yahoo! Parenting, (December 2015). Accessed at: https://www.yahoo.com/parenting/how-cord-blood-turned-this-4-year-olds-life-120046644.html.

Grenoble, Ryan. “These Advances In Lab-Grown Organs Might Save Your Life One Day.” Huffington Post, (October 2015). Accessed at: http://www.huffingtonpost.com/entry/lab-grown-organs-transplant-technology_562122cee4b08d94253ee660.

Hoffman, Jason. “Autologous HCT Similarly Effective in Older Patients With Myeloma vs Younger Patients.” Cancer Therapy Advisor, (February 2016). Accessed at: http://www.cancertherapyadvisor.com/multiple-myeloma/multiple-myeloma-autologous-hct-older-younger-patients-risk/article/476190/.

Oakley, Nancy. “Game Changers.” Winston-Salem Monthly, (September 2015). Accessed at: http://www.journalnow.com/winstonsalemmonthly/game-changers/article_e7387cba-4c25-11e5-80dc-9b6fa543aee7.html.

Rao, Mahendra S. and Katherine S. Brown. “Cord Blood Stem Cells-An Effective but Undervalued Tool in Clinical Trial Strategy.” Genetic Engineering & Biotechnology News, (November 2015). Accessed at: http://www.genengnews.com/keywordsandtools/print/3/39868/.

Reardon, Sara and David Cyranoski. “Japan stem-cell trial stirs envy.” Nature, (2014). Accessed at: http://www.nature.com/news/japan-stem-cell-trial-stirs-envy-1.15935.

Shaer, Matthew. “Soon, Your Doctor Could Print a Human Organ On Demand.” Smithsonian Magazine, (May 2015). Accessed at: http://www.smithsonianmag.com/innovation/soon-doctor-print-human-organ-on-demand-180954951/?no-ist.

Shapiro, Jeffrey K. and Charlene Cho. “Proposed Legislation Would Create a New Conditional Approval Pathway to Market for Regenerative Medicine Products.” FDA Law Blog, (2016). Accessed at: http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/03/proposed-legislation-would-create-a-new-conditional-approval-pathway-to-market-for-regenerative-medi.html.

Taylor, Phil. “Stem cell therapy promising for rheumatoid arthritis.” PM Live, (2016). Accessed at: http://www.pmlive.com/pharma_news/stem_cell_therapy_promising_for_rheumatoid_arthritis_936715.