Regulatory Issues in the Therapeutic Use of Stem Cells

Unfortunately, clinics around the world are exploiting patients’ hopes by offering supposed stem cell therapies, without credible scientific rationale, oversight or patient protections. Occurring particularly in Asia and South America, treatments which are illegal in most counties are being offered for what are often considered incurable conditions, such as brain tumors, congestive heart failure or chronic obstructive pulmonary disease. In addition, countless other conditions are listed as candidates by these clinics including eye disease or orthopedic injuries or disease. In response to this, the International Society for Stem Cell Research (ISSCR) released “The Guidelines for the Clinical Translation of Stem Cells” which called for rigorous standards in the development of stem cell therapies and outlining what needs to be accomplished to move stem cells from promising research to proven treatments[1]. The goal of ISSCR in shining this light on the dangers of stem cell tourism is to ensure that the promise of stem cell research is delivered to patients in a safe, effective and fair manner. A number of professional organizations have also published guidance documents for the responsible conduct in translational stem cell research.