Unproven stem cell therapy goes to trial

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.

The Senate’s acceptance of the amended decree brings it into law. The Stamina Foundation can no longer accept new patients for its unproven procedure, which is to be evaluated in a government-funded 3 million euro clinical trial of the treatment.

This trial is to take place according to rules set by the European Medicines Agency and its Italian counterpart, AIFA, under the EU Regulation on advanced therapies (Regulation (EC) No 1394/2007). Cells used in the trial will be manufactured according to Italy’s legal safety standards, under good manufacturing practice (GMP).

An experimental protocol will now be prepared to test the Stamina method. Three official agencies – AIFA, The Istituto Superiore di Sanità (ISS) and the National Italian Transplant Centre (CNT) – will be involved in trial oversight.

Scientists who had previously spoken out about this case have responded positively to the Senate’s decision. Professor Michele De Luca, director of the University of Modena and Reggio Emilia’s Interdepartmental Centre for Stem Cells and Regenerative Medicine, commented:

“This decision provides a wise ending to a fierce political debate that has inflamed public opinion in the last few weeks, in which the role of science-based medical rules was dangerously threatened by hastily unwise decisions. Originally, Stamina planned to provide patients with something it already termed a “therapy” in the absence of any evidence of safety and efficacy and outside the current EU regulations for advanced therapies. Now, in what is still a regulatory compromise, they have to demonstrate whether their “therapy” is real or rather an illusion similar to snake oil."

UPDATE October 2013 -  Plans to begin the trial are cancelled.  The scientific method used by the Stamina Foundation was analysed by a scientific committee appointed by Italy's health minister.  The flaws they highlighted, for example that a flawed method used to detect the idenity of the cells that were transfused and a lack of basic screening for pathogens.  This along with earlier analysis that showed the cells transfused were blood cells and did not contain any neurons, raised significant safety concerns and the trial was stopped.   

UPDATE June 2015 -The highest court (Cassazione) once more establishes that the Stamina method has nothing to do with scientific method. The investigations revealed that a number of risks have emerged related to the activity of manipulation and administration of stem cells if these are given to patients without the necessary regulations and beyond the procedures as prescribed by Italian and European law.