A controversial and unproven stem cell procedure is to be evaluated in a controlled clinical trial, following a vote in the Italian Senate last week.

The Italian Parliament’s Chamber of Deputies had last Monday voted to amend an earlier controversial decree by Italian Senate, which allowed the unproven stem cell method developed by the Stamina Foundation to be used for severely or terminally ill new patients for 18 months.

An unproven stem cell therapy has taken centre stage in Italy after patients successfully lobbied the Italian government to allow its use in public hospitals. The highly controversial and untested procedure was created by the privately owned Stamina Foundation, but blocked by the Italian Medicine's Agency, AIFA. Last week's decision by the Ministry of Health to override AIFA's block has horrified Italy's leading stem cell scientists. In a letter to the Ministry, they describe the decision as providing "a dangerous short circuit between patients' hopes and lucrative commercial practices" of organisations operating outside the "scientific and moral foundations" of medicine.

A specialist discussion event regarding the revision of the EU Clinical Trials Directive (CTD) was held at the European Parliament Information Office in London on the 22nd of February 2013.  This event was initiated by EuroStemCell and OptiStem in collaboration with the European Parliament Office in London and featured OptiStem Principal Investigator, Prof Michele De Luca as a panellist. Read on for a description of the event from Georgina Massouraki and a storify summary of lots of interesting event tweets, put together by Corin Campbell.

Last year, the European Court of Justice ruled that no patents can be granted in Europe for inventions or technologies based on the use of embryonic stem cells. In a recent article, Professor Aurora Plomer, Chair of Law and Bioethics at the University of Sheffield, UK, argues that the Court's decision "represents an unprecedented and illegitimate constitutional interference with the autonomy of member states and a setback for science and the rights of those suffering from crippling diseases".

Patient associations and leading research funders have called on the European Parliament to continue EU funding for embryonic stem cell research. The Wellcome Trust issued the group's joint statement last Friday 15th June, ahead of parliamentary debates this week in which MEPs will discuss the EU's next major research and innovation funding programme, 'Horizon 2020'.

Over 100 Italian and UK scientists and politicians came together on 12^th December for a Summit on Regenerative Medicine organized by the Italian Embassy in London and the School of Science Technology and Health, University Campus Suffolk. Their aim: to bring the collective expertise of academics, industry and the political world to bear on the question of how to take basic stem cell research towards the clinic.

The European Court of Justice has today announced a landmark decision banning patenting of inventions based on embryonic stem cells. Scientists are concerned that the verdict, which is legally binding for all EU states, will drive development of stem cell therapies outside Europe.

Stem cell therapy is moving steadily toward worldwide clinical application for a broad range of inherited and acquired diseases. In countries where biomedical research progress is both widely publicised and tightly regulated, it is understandable for those who stand to benefit from the regenerative potential of stem cell therapies to seek more rapid access to treatments. This situation is conducive to practitioners operating under lax regulatory conditions offering treatment to patients travelling from overseas. Indeed, there is good evidence that stem cell therapies are an important driver of medical tourism and good reason to believe that some patients who travel for stem cell therapy are receiving ineffective or harmful interventions.

Rogue clinics are the scourge of the serious enterprise of stem cell research and its application. They are a risk to patients and to a respectable field of scientific and clinical endeavour with very laudable aims. Therefore rational stem cell scientists will be keen to promote any realistic measure to deal with them. Many are taking action by working to produce agreed guidelines for best practice, and helping to educate regulators and members of the public. In an article published in EMBO Reports, Master and Resnik [1] argue that stem cell scientists should do more to tackle these rogue clinics by controlling access to materials and methods through documents called Material Transfer Agreements (MTAs). You can read a short summary of their proposal in our introduction. I do not think this particular strategy is useful for several reasons.

(C) Uta Mackensen / EMBO reportsMany clinics offering unproven stem cell therapies have appeared in recent years. What can we do to prevent exploitation of patients made vulnerable by their desperation for a cure? Efforts so far have often focused on informing patients of the risks, or enhancing regulation of stem cell research or therapy.  An article published today in the journal EMBO Reports argues that another strategy is needed; and stem cell scientists have a key role to play.