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Minister halts Italian stem-cell therapy trial

Posted on behalf of Alison Abbott

The clinical trial of a controversial stem-cell therapy supported by the Italian government has been stopped before recruiting any patients – to the relief of scientists who have been fighting the trial for months.

On 10 October, health minister Beatrice Lorenzin announced that she would follow the advice of a special panel of scientific advisors and disallow the trial. In their stinging report, the advisors described the clinical protocol submitted by the Brescia-based Stamina Foundation as scientifically unfounded and potentially dangerous.

“This is the end of the matter,” says Luca Pani, president of the Italian Medicines Agency. “And we are very happy.”

The Stamina affair had been polarising Italian society for more than a year. Stamina had been treating seriously ill patients since 2007 before its laboratory was closed down for safety reasons in August last year. Patient groups lobbied passionately for access to the therapy, but experts warned that the approach had no scientific base and could be dangerous.

The government decided in March to finance a €3million trial to put the clinical protocol to the test (see ‘Stem-cell ruling riles researchers‘). But when Nature revealed that the protocol itself was fraudulent, the scientists called for the trial to be abandoned (see ‘Italian stem-cell trial based on flawed data‘).

Davide Vannoni, Stamina’s president, immediately announced plans to move the trial abroad. The Turin-based pharmaceutical company Medestea which finances the Stamina Foundation says it will take the therapy to China.




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