**1. Introduction**

#### **1.1. Stem cell tourism**

Advances in stem cell research and media publicity of stem cell potential have raised the hopes of patients with severe disabilities and conditions which lack a cure. While stemcell-based therapies are the clinical standard of care for a few conditions, such as leuke‐ mia and more recently for some burns and corneal disorders, stem cell tourism continues to rise worldwide.

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.

The general public receives information regarding stem cell potential from mainstream media and does not fully understand the risks associated with unproven treatments. In the

© 2013 Deasy et al.; licensee InTech. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. © 2013 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

most desperate situations, patients may see no other options, or may view the years of continuing research as an obstacle to their potential cure. Yet, untested treatments can be dangerous and years of preclinical and clinical research are required to determine which novel stem-cell based therapies are effective and safe. In one example, brain tumors were discovered in a 9-year old boy who travelled to Russia to receive stem cell treatments to his brain; later it was found that the tumors were the result of cells from at least 2 different donors [2]. Even carefully planned and approved studies can go wrong and have unfortu‐ nate results, as in the fatal gene therapy case of Jesse Gelsinger, who received experimen‐ tal therapy at University of Pennsylvania[3, 4].

Lau et al reported on the clinics around the world that are exploiting patients' hopes by professing to have effective stem cell therapies for seriously ill patients. These therapies often carry a hefty pricetag. However, they occur in counties which have limited oversight and allow treatment to occur in the absence of credible scientific rationale, transparency, oversight, or patient protections [5].

Comprehensive government regulations exist in the US, and several other countries. Below, we describe the U.S. and other government regulations associated with the use of human stem cell and tissues in regenerative medicine.
