[Nikolas]

Italian research foundation like 'Stamina' have raised ethical questions, even legal ramifications and protests to a certain level.

Stem cell research has become quite popular in the last few years. The potential of stem cells is invaluable in regenerative medicine research. Many papers have been written, many different therapies proposed and just some approved for clinical testing, but for now, medicine based on stem cells remains experimental and very costly. Most countries possessing stem cell research hold it under strict regulation, and require sound evidence and theory to allow testing of such therapies, most notably human trials.

Stem cell approaches used in medicine are most often based on their ability to maintain and repair tissue by replacing senescent cells in adult organisms. The prevailing part of stem cell and regenerative medicine research is conducted by utilizing embryonic stem cells, which is controversial by itself, because it involves the destruction of embryos. In contrast to that, adult stem cells are also available and being worked upon. Adult stem cells by comparison have a lesser degree of multipotence then embryonic stem cells, being able to assume the role of a smaller number of adult cells and tissues.

May last year, an Italian research foundation named “Stamina” had its research halted by the Italian government due to several issues concerning the effectiveness and viability of their adult stem cell research. As stated by the health inspectors, the conditions in Stamina’s laboratory were “unsanitary, with terrible maintenance and a critical lack of cleanliness, resulting in highly inadequate conditions”. But, March this year; the Italian government overruled the decision to halt the Stamina research by allowing the company to continue their experimental therapies on 32 terminally ill patients, some of them children. Many scientists across Europe have sent letters to the Italian health minister regarding this decision, stating their concerns about this untested, unproven and theoretically unsound research. Such blatant disregard of protocol and established rulings may cause harm to other, viable stem cell research being conducted in appropriate conditions, with sound theories behind them – say the scientists. They continue to say that Stamina’s therapies may prove harmful to the patients and cause unforeseen collateral damage.

"There is no rationale for this and no evidence that these procedures are not dangerous for patients," said Professor Michele De Luca of the University of Modena. One of the main concerns of the scientists remains the disregard of established European licensing criteria, which were put in place to prevent the exploitation and harming of patients.

The patients families have filled class action motions via their lawyers, with the judges preceding over these cases stating that a modification of the law is necessary, to allow to terminally ill patients to undergo experimental treatment which might potentially save their lives, however small the chance.

The judges and supporters of the ruling have stated that it would be cruel to deny the therapies to the patients, considering it has not shown any “grave collateral effects”.

"These unproven and ill-prepared stem cell therapies, for which there is no scientific basis, will do nothing for patients and their families except make them poorer," said Charles French-Constant from the University of Edinburgh's Center for Regenerative Medicine.

This decision by the Italian Health minister was made as a result of receiving several emotional pleas from the parents of terminally ill children, and an increasing media pressure to “give them a chance”. Protest were held in the Roman square, with one notable protester, an almost naked woman, having the words “Yes to Life, yes to Stamina” written on her body. The scientists fear that the decision was based solely on emotional and political pressure and serves no good either to the patients or the scientific community. The minister himself has stated that this ruling was mainly brought about by “compassion”, and that the experimental treatment will continue only in public hospitals and under strict monitoring.

"The decision of the government to authorize the continuation of therapies ordered by judges was necessary to prevent discrimination, based on autonomous decisions by judges, between patients who had begun treatment with the Stamina Method," Balduzzi, the Italian minister of Health stated.

Several British scientists have stated that this ruling by the Italian government presents a dangerous precedent, and may encourage patients to look for experimental treatments abroad, disregarding the validity or safety of such therapies.