Stem cell therapy: medico-legal perspectives in Italy

Ethical and juridical issues have recently been raised in Italy regarding experimental stem cell therapy (Stamina), which was authorized but then stopped after it was administered to a wide range of patients as a compassionate treatment for neurodegenerative diseases (Carrozzi et al. Research in the field of somatic stem cells isolated from adult organs has been developed over the last few decades as a powerful tool in regenerative medicine. In particular, most experimental tissue regenerative applications are based on the use of mesenchymal stem cells (MSCs) to regenerate damaged tissues (Biffi et al., 2013). Some have claimed that MSCs could be capable of neuronal transdifferentiation, though this feature is poorly substantiated and widely contested (Brundin et al. Despite the fact that numerous ongoing studies and clinical trials have exploited such stem cells in the treatment of bone and soft tissue defects, no studies have investigated their possible application in the field of degenerative diseases affecting non-mesodermal organs. Hence, yielding promising results could produce higher expectations in poor prognosis patients and in their The complicated sequence of events of the so-called " Stamina " method has garnered keen public support, but equally, scientists' opposition. This has generated a long and complex investigation by the Public Prosecutor's office in Turin regarding accusations of criminal conspiracy aimed at fraud, unlawful medical practice, violation of privacy norms and many other crimes. No details of these innovative protocols have been provided by the promoters of this method, who generically claimed that they were able to differentiate bone marrow MSCs into nerve cells for the treatment of neurological, genetic, and autoimmune diseases. The principles of these studies seem to derive from two Russian and Ukranian papers (Schegel'skaya et al., 2003; Yavorskaya et al., 2006). Only very recently, the results obtained in three patients have been described, although the description of the experimental protocol is still inadequate (Villanova and Bach, 2015). However, this story finally caused the Public Health System to be involved in a legal dispute, as the method was claimed to represent a compassionate treatment, for which unlimited access should be granted. A compassionate therapy is administered when there is no alternative to the experimental therapy—in the broadest sense of the term, with the relevant variables—even in order to grant the patient and their relatives a dignified coexistence with a pathological condition which would otherwise be progressive, irreversible and lethal. Indeed the protection of the …