This invaluable resource discusses the saftey, ethics, and regulations of developing stem cell clinical applications. Each chapter is contributed by a preeminent scientist in the field and covers such topics as clinical safety of stem cell gene therapy, the patentability of hESC technologies, international guidelines, challenges to international stem cell clinical trials, worldwide regulations including in emerging markets like China and Taiwan.
Dedication to President Barack Obama After the defunding of stem cell research by President Bush in 2001 due to the use of human embryonic stem cells (hESCs), the science of regenerative medicine became stagnant and many scientists left the country to set-up labs abroad. It had been anticipated that this emerging science could affect cures for diseases such as diabetes, heart disease, Parkinson’s, blindness, cancer – just to name a few. Prior to his death in 2004, Christopher Reeves, the actor famous for his role as Superman, was hopeful for a cure for his spinal injuries but was often frustrated by the limits placed on stem cell research in the United States. However, the controversy over embryonic cells subsided when, according to the Embryo Project, Induced Pluripotent Stem Cells (iPSCs) became “derived from non-pluripotent cells, such as adult somatic cells, that are genetically manipulated so as to return to an undifferentiated, pluripotent state. Research on iPSCs, initiated by Shinya Yamanaka in 2006 (in Japan) and extended by James Thompson (University of Wisconsin) in 2007, has so far revealed the same properties as embryonic stem cells (hESCs), making their discovery potentially very beneficial for scientists and ethicists alike.” No human eggs are required for these cells. As declared by the NIH (National Institute of Health) “On March 9, 2009, President Barack H. Obama issued Executive Order 13505: Removing Barriers to Responsible Scientific Research Involving Human Stem Cells. The Executive Order states that the Secretary of Health and Human Services, through the Director of NIH, may support and conduct responsible, scientifically worthy human stem cell research, including human embryonic stem cell (hESC) research, to the extent permitted by law.” This executive order allows federally funded researchers to experiment on hundreds of ES (Embryonic Stem) cell lines that were restricted by President Bush. Because of President Obama, this new genesis of medicine has the ability to transform the accompanying health and longevity of humankind beyond anything we can currently imagine. As the science of regenerative medicine evolves, cures of heretofore “incurable” diseases will begin to appear. It is even predicted that in the next quarter century we will be able to eliminate biological aging and remain looking young for an indefinite period of time. In my opinion, regenerative medicine will be Obama’s greatest legacy.