Reports and Peer-Reviewed Publications

Atala, Anthony and Julie Allickson. Translational Regenerative Medicine. 2014. Accessed at:

Bipartisan Policy Center. (2015). “Advancing Regenerative Cellular Therapy: Medical Innovation for Healthier Americans.” Accessed at:

California Institute for Regenerative Medicine. (2014).  “2014 Annual Report.” Accessed at:

California Institute for Regenerative Medicine. (2014). “Proceedings: International Regulatory Considerations on Development Pathways for Cell Therapies.” Accessed at:

Caplan, Arnold I. “Legislation for today’s cell and tissue based therapies.” CellR4 4 (2): e1804. (2016). Accessed at:

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:

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:

Japan Ministry of Health, Labour and Welfare. Outline of the Law for Partial Revision of the Pharmaceutical Affairs Law (Act No.84 of 2013).

JCR Pharmaceuticals Co. (2015). “JCR Receives Approval for TEMCELL® HS Inj., The First Allogeneic Regenerative Medicine in Japan.” Accessed at:

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:

Pharmaceuticals and Medical Devices Agency. (2015). “ACTO Satellite Symposium: Japanese Regulation of Regenerative Medicine.” Accessed at:

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:

Slabiak, Trina. “Stem Cell-based Therapies and FDA Regulations.” Regulatory Focus, (2012).

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:

Trounson, Alan, Courtney McDonald. “Stem Cell Therapies in Clinical Trials: Progress and Challenges.” Cell Stem Cell 17 (1): 11-22. (2015). Accessed at:

von Tigerstrom, Barbara. “Revising the Regulation of Stem Cell‑Based Therapies: Critical Assessment of Potential Models.” Food and Drug Law Journal (2015). Accessed at:

News Articles:

Atala, Anthony. “Study Shows How Stem Cells Might Restore Bones Damaged by Osteoporosis.” Stem Cells Portal, (2016). Accessed at:

Binsted, Tim. “Mesoblast stem cell therapy approved by Japanese health watchdog.” Syndey Morning Herald, (September 2015). Accessed at:

Cyranoski, David. “China announces stem-cell rules.” Nature, (2015). Accessed at:

deBruyn, Jason. “Duke receives $15M to study potential autism treatment using umbilical cord blood.” Triangle Business Journal, (June 2014). Accessed at:

Frist, William H. and Bart Gordon. “Time to pass medical innovation legislation.” The Hill, (February 2016). Accessed at:

Grant, Bob “CIRM Ups Translational Velocity.” The Scientist, (December 2015). Accessed at:

Greenfield, Beth. “How Cord Blood Turned This 4-Year-Old’s Life Around.” Yahoo! Parenting, (December 2015). Accessed at:

Grenoble, Ryan. “These Advances In Lab-Grown Organs Might Save Your Life One Day.” Huffington Post, (October 2015). Accessed at:

Hoffman, Jason. “Autologous HCT Similarly Effective in Older Patients With Myeloma vs Younger Patients.” Cancer Therapy Advisor, (February 2016). Accessed at:

Oakley, Nancy. “Game Changers.” Winston-Salem Monthly, (September 2015). Accessed at:

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:

Reardon, Sara and David Cyranoski. “Japan stem-cell trial stirs envy.” Nature, (2014). Accessed at:

Shaer, Matthew. “Soon, Your Doctor Could Print a Human Organ On Demand.” Smithsonian Magazine, (May 2015). Accessed at:

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:

Taylor, Phil. “Stem cell therapy promising for rheumatoid arthritis.” PM Live, (2016). Accessed at: