Italian regulation of ‘unproven’ stem cell therapies ‘of global concern’, write scientists

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The Italian Parliament is debating whether to change a recent law that would make it legal to practice ‘unproven' stem cell treatments in public hospitals. To express their concerns about the safety of such treatments, an international group of stem cell researchers have issued a statement in The EMBO Journal (published online 3 May 2013).

It seems that a privately-owned organization had been offering a stem cell treatment in Italy, but the therapy was apparently banned by Italian regulators last year (Reuters). However, the Health Minister Renato Balduzzi issued an official decree on March 21 2013 that allowed the 32 terminally-ill patients already using the treatment to continue with it – a move that reportedly incensed scientists who considered the treatment to be unproven and possibly unsafe (Nature). With the Italian Chamber now soon to decide on whether to proceed with the controversial legislation, a group of stem cell researchers have issued a full statement in The EMBO Journal to voice their concerns.

"The treatment, offered by a private non-medical organization, may not be safe, lacks a rationale, and violates current national laws and European regulations," write the authors. "This case raises multiple concerns, most prominently the urgent need to protect patients who are severely ill, exposed to significant risks, and vulnerable to exploitation."

With regards to the case in Italy, the authors report that "patients with disparate, severe neurological diseases were and are being treated, and will continue to be treated in a major public hospital in Italy, by intravenous and intrathecal infusions of ‘MSCs'".

The strongly-worded statement discusses the safety issues with mesenchymal stem cells (MSCs) and the importance of ensuring safety during manufacturing. Advocates of such treatments in Italy argue for its use in compassionate circumstances, but the authors counter this by saying that there can be no compassion without being certain of safety and efficacy. The authors also argue that the range of diseases purportedly being treated with the intravenous of intrathecal infusion of MSCs – a list that includes Spinal Muscular Atrophy and Parkinson's disease – differ widely in their cause, mechanism and natural history.

"The Italian case suggests that pressure for premature translation of inconclusive science can also encourage, albeit indirectly, practices that are destructive for patients," conclude the authors.

Read the whole EMBO Journal article here: Regulation of stem cell therapies under attack in Europe: for whom the bell tolls.

What do you think? Do you agree with the sentiments expressed by the scientists in the EMBO Journal statement? Or are you in favour of the stem cell treatment offered? Do you think that the translation of stem cell therapy into clinical practice has come too soon?

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