5numerous false, misleading, and inaccurate statements and that the proffered
information had no scientifi c credibility. It further found that the stem cell treat-
ments were illegally administered without a biologics product license (Public
Health Services Act, Section 262(a)(1) 2011 ) and that licensing was very unlikely
as preclinical trials in this regard only involved nonhumans. None of the patients
undergoing these treatments were cured and many even died during the course
thereof (Mahomed and Nöthling Slabbert 2012 ).
Medical tourism in this context can broadly be divided into three categories
(IOM and NAS 2014 ):
1.2.1.1 According to the Legal Status of the Treatment
Some treatments are illegal in the patient’s home country but legal in the destination
country, a medical tourism style known as circumvention tourism , which includes
abortion, assisted suicide, and stem cell treatments. Sometimes stem cell treatments
might not necessarily be illegal in a patient’s home country, but simply unavailable
due to the fact that they are not yet approved.
1.2.1.2 According to Who Is Paying for the Treatment
In some cases, patients are paying from their own funds, but increasingly large
insurers in the USA and Australia pay for medical tourism packages to nationals
who are looking for lower-cost options elsewhere in clinics with guaranteed safety
and quality (Parnel 2013 ). However, insurers in the USA typically refuse payment
for experimental or investigational treatments unless clinical safety and effective-
ness have been proven.
1.2.1.3 According to Where Patients Are Traveling for Treatment
Patients may travel from one developed country to another developed country, from
a developed country to a less developed country, or from a less developed country
to a more developed country.
However, progressing from basic research to clinical research to eventual transla-
tion thereof is a long, laborious, and expensive process with an increase in the num-
ber of patients at every successive stage, which means a similar increase in costs and
risks. However, the majority of stem cell clinical trials are in the early stages, enroll-
ing only a small number of patients (Trouson et al. 2011 ). The translation of stem
cell therapy will only be safely and effectively achieved through international col-
laboration, including the sharing of research information to improve global public
health. Advances in science and technology will facilitate the development of safe
and effective biological products, thereby advancing regulatory science and research
and managing organizational excellence and accountability (CBER 2011 ).
1 Stem Cell Therapy: Accepted Therapies, Managing the Hope of Society...