A scientific advisory committee in Italy yesterday (11 September) gave a decided thumbs down to a controversial stem-cell treatment slated for a €3-million (US$4-million), government-sponsored clinical trial.
The committee had been appointed by the health minister to evaluate the clinical protocol proposed by the Brescia-based Stamina Foundation, which developed the therapy.
The government had agreed in May to support the trial, after lobby groups of patients protested that they were being denied their only hope for cure. The Italian Medicines Agency had closed the Brescia facility on safety grounds after a site inspection in May 2012.
The therapy involves extracting stem cells from the bone marrow of patients, manipulating them in a dish, and re-infusing them into the same patients. Scientists argue that the treatment — which has already been administered to more than a hundred very sick adults and children — is unlikely to be effective, and could be dangerous. They called for the trial to be halted after revelations in July that Stamina chief Davide Vannoni and his colleagues had presented flawed data in patent applications describing the method.
After missing several deadlines, Vannoni finally submitted his clinical protocol for the trial to the committee on 1 August. At a press conference the scientific advisory committee declared it to be “unscientific”.
Health minister Beatrice Lorenzin must now decide whether to abort the trial.