Title : Ethical and regulatory issues in stem cell research and regenerative medicine. Puzzling the controversial debate worldwide.
Advances in tissue engineering and regenerative medicine (TERM) have generated considerable interest both in scientific and public domain. Although significant results have been reached over the last two decades in this field, several scientific, commercial and ethical constraints are at stake within the international community. With regard to ethical and regulatory perspectives, this abstract considers prominent issues related to the use of human stem cells for research and clinical applications such as 1) implications for donors, 2) stem cell tourism, 3) the patient right to try in relation to stem cell based emerging therapies. While the use of embryonic and fetal cells from aborted fetal tissues raises controversial ethical debate in several countries, adult stem cells have fewer ethical and regulatory constraints. However they encounter some resistance in relation to specific cell manipulations such as “therapeutic cloning” and collection for autologous applications. Furthemore the use of adult stem cells usually raises a problem of consent. Indeed, due to the unforeseability or uncertainty of the use of stem cells and particularly of immortalized cell lines over the future decades it is quite difficult to obtain a really true informed consent at the time of specimen collection. Therefore the specific nature of stem cell research may raise the need to recontact donors/ families over time for a new consent or a re-consent. In addition confidentiality may be controversial with regard to research on hereditary conditions or where genetic disorders are not confirmed. Donors may have concerns about potential genetic discriminations. Another ethical quandary in the development of any novel therapy relates to the patient “right to try” and the ususally associated “stem cell tourism”. Given the tension between the need to safeguard public safety and the freedom of patients to access to experimental therapies, it is a challenging to define appropriate policies that strike the right balance. This abstract aims to explore these issues by trying to puzzling the controversial debate worldwide and offering some ethical and policy response which may support an ethical advances of stem cell research and its related applications.