Ethical and Regulatory Challenges with Autologous Adult Stem Cells: A Comparative Review of International Regulations

[1]  G. Phillips,et al.  Research and development expenditure , 2018, Innovation and Technology Transfer in Japan and Europe.

[2]  P. Knoepfler,et al.  Selling Stem Cells in the USA: Assessing the Direct-to-Consumer Industry. , 2016, Cell stem cell.

[3]  D. Sipp,et al.  Undertested and Overpriced: Japan Issues First Conditional Approval of Stem Cell Product. , 2016, Cell stem cell.

[4]  S. Sugii,et al.  Uncertain Oversight of Regenerative Medicines in Japan under the ASRM. , 2016, Cell stem cell.

[5]  D. Sipp,et al.  Dislodging the Direct-to-Consumer Marketing of Stem Cell-Based Interventions from Medical Tourism , 2016 .

[6]  A. Akabayashi,et al.  The current status of clinics providing private practice cell therapy in Japan. , 2016, Regenerative medicine.

[7]  Srinivasan N. Kellathur.  Regulation of Cell- and Tissue-Based Therapeutic Products in Singapore. , 2015, Tissue engineering. Part A.

[8]  L. Turner.  US stem cell clinics, patient safety, and the FDA. , 2015, Trends in molecular medicine.

[9]  Minoru Ono,et al.  Safety and Efficacy of Autologous Skeletal Myoblast Sheets (TCD-51073) for the Treatment of Severe Chronic Heart Failure Due to Ischemic Heart Disease. , 2015, Circulation journal : official journal of the Japanese Circulation Society.

[10]  K. Azuma.  Regulatory Landscape of Regenerative Medicine in Japan , 2015, Current Stem Cell Reports.

[11]  Daisaku Sato,et al.  New Japanese initiatives on stem cell therapies. , 2015, Cell stem cell.

[12]  Cameron Stewart,et al.  Erratum to: Untested, unproven, and unethical: the promotion and provision of autologous stem cell therapies in Australia , 2016, Stem Cell Research & Therapy.

[13]  MunsieMegan,et al.  Regulatory loophole enables unproven autologous cell therapies to thrive in Australia. , 2014 .

[14]  I. Kerridge,et al.  The emergence and popularisation of autologous somatic cellular therapies in Australia: therapeutic innovation or regulatory failure? , 2014, Journal of law and medicine.

[15]  M. Pera,et al.  Regulatory loophole enables unproven autologous cell therapies to thrive in Australia. , 2014, Stem cells and development.

[16]  I. Kerridge,et al.  Oversight for clinical uses of autologous adult stem cells: lessons from international regulations. , 2013, Cell stem cell.

[17]  I. Kerridge,et al.  Global bionetworks and challenges in regulating autologous adult stem cells. , 2013, The American journal of medicine.

[18]  G. Daley,et al.  The promise and perils of stem cell therapeutics. , 2012, Cell stem cell.

[19]  J. Rasko,et al.  Promises and Challenges of Stem Cell Research for Regenerative Medicine , 2011, Annals of Internal Medicine.

[20]  A. Trickett,et al.  Regulation of cellular therapy in Australia , 2011, Pathology.

[21]  M. Sleeboom-Faulkner,et al.  Experimental stem cell therapy: Biohierarchies and bionetworking in Japan and India , 2011, Social studies of science.

[22]  C. Herberts,et al.  Risk factors in the development of stem cell therapy , 2011, Journal of Translational Medicine.

[23]  A. Hollander.  A CASE STUDY OF EXPERIMENTAL STEM CELL THERAPY AND THE RISKS OF OVER-REGULATION , 2010 .

[24]  D. Chalmers.  Stem Cell Technology: From Research Regulation to Clinical Application , 2010 .

[25]  D. Mathews,et al.  Medicine on the Fringe: Stem Cell‐Based Interventions in Advance of Evidence , 2009, Stem cells.

[26]  M. Sleeboom-Faulkner,et al.  Bionetworking: experimental stem cell therapy and patient recruitment in India , 2009, Anthropology & medicine.

[27]  C. Holden.  A First Step in Relaxing Restrictions on Stem Cell Research , 2009, Science.

[28]  T. Caulfield,et al.  Stem cell clinics online: the direct-to-consumer portrayal of stem cell medicine. , 2008, Cell stem cell.

[29]  D. Sipp,et al.  Offshore stem cell treatments , 2008 .

[30]  C. Weijer,et al.  Rehabilitating Equipoise , 2003, Kennedy Institute of Ethics journal.

[31]  B. Freedman.  Equipoise and the ethics of clinical research. , 1987, The New England journal of medicine.

[32]  William G. Smith,et al.  Current status , 1984 .

[33]  R. Shores,et al.  Evaluation and Research , 1979 .