A long-running controversy sparked by the Italian government’s decision to fund a clinical trial of an unapproved stem cell therapy may have reached its final chapter. Last week, a panel of experts appointed by the Italian Ministry of Health concluded that the trial of the so-called Stamina method should not move forward.
A similar panel reached the same conclusion in 2013, citing scientific flaws and safety concerns, but that ruling was set aside after a legal challenge. This time, Italy’s minister of health, Beatrice Lorenzin, says the new panel’s 3 October recommendation is final and has vowed to block any trial.
Meanwhile, 20 people involved in promoting the therapy, including its leading proponent, are facing allegations of criminal conduct. In April, Italian prosecutors released a report alleging that the group was engaged in fraud by selling the therapy to patients. In November, a judge is expected to hold a hearing on whether the case will move forward.
The controversy stretches back to 2006, when the Stamina Foundation, a private organization based in Turin, began promoting the stem cell treatment, which has not been approved by Italian regulators. Foundation President Davide Vannoni claims that the therapy, based on bone marrow stem cells, can promote the growth of new neurons and hence cure a vast range of neurodegenerative diseases. In 2013, the Italian Parliament earmarked €3 million for a trial, amid pressure from patients and some media outlets, and despite investigations by health care officials that resulted in decrees to halt the treatments. The decision to fund the trial drew immediate criticism from stem cell researchers and others, prompting officials to order the initial 2013 expert review.
Vannoni continues to back the therapy, despite last week’s setback. “The decision has left me amazed,” he tells ScienceInsider. The committee was supposed to only fine-tune the design of the trial, he says, not rule on its feasibility. Vannoni says he will again go to court in an effort to set aside the panel’s conclusions. He won a similar case in 2013, when a judge ruled that some members of the original panel that reviewed the work were not impartial.
No patients are currently receiving the Stamina treatment, in part because prosecutors in Turin recently seized vials containing patient cells and tissues from a hospital involved in the therapy. And Luca Pani, director of Italy’s drug regulator, AIFA, says his agency’s investigations show that the treatments should not resume. Investigators found “a number of serious violations which leave no room for interpretation,” he said in a statement issued after the panel issued its recommendation. “In any Western advanced country, a few pages of that decree would have been sufficient to determine the cessation of any activity.”