Controversial stem-cell therapy gets second shot at clinical trial.
The regional administrative court of Lazio, Italy, today ruled unlawful the scientific committee that had advised the health minister not to proceed with a planned €3-million (US$4-million) clinical trial of a controversial stem-cell therapy.
That gives the Brescia-based Stamina Foundation, headed by Davide Vannoni, a second chance to push for the government-sponsored trial that the committee had declared as lacking a scientific basis and potentially dangerous.
In its written judgment — a ruling on an appeal filed by Vannoni — the court said that the committee was not appropriately objective because its members had previously publicly expressed negative opinions against the validity of the method. It said that the committee members should have been recruited from experts, possibly foreign, who have not already commented on the case.
Health minister Beatrice Lorenzin was quoted in the daily newspaper La Stampa as saying that she would immediately select a new committee of experts in line with the court’s ruling.
But Amedeo Santosuosso, a judge himself and a member of the discredited committee, criticized the judgment, which he describes as suitable only for a political committee, for which representation of different views is necessary. “A technical committee requires technical experts, and those who are identified as experts will have published in the area. The court’s ruling undermines the function of a technical committee,” he says.
Vannoni has been lobbying hard for permission to use his therapy, which involves extracting bone marrow stem cells from patients with a wide range of incurable diseases and injecting them back into the blood or spine of the same patients. On 25 November, he held a protest in front of the Chamber of Deputies in Rome with patients who threw blood at pictures of Italy’s prime minister and president. In July, it was revealed that Vannoni's patent applications on his protocol used flawed data.
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Abbott, A. Italian court rules science advisers unlawful. Nature (2013). https://doi.org/10.1038/nature.2013.14307