Italian stem-cell trial based on flawed data

The controversial stem cell therapy has garnered fervent public support, while many scientists decry it as unproven.

MMaurizio D'Avanzo/Milestone/Empics Entertainment

Davide Vannoni, a psychologist turned medical entrepreneur, has polarized Italian society in the past year with a bid to get his special brand of stem-cell therapy authorized. He has gained fervent public support with his claims to cure fatal illnesses and equally fervent opposition from many scientists who say that his treatment is unproven.

Now those scientists want the Italian government to pull out of a 3-million (US$3.9-million) clinical trial of the therapy that it promised to support in May, after bowing to patient pressure. They allege that Vannoni's method of preparing stem cells is based on flawed data.

And Nature's own investigation suggests that images used in the 2010 patent application, on which Vannoni says his method is based, are duplicated from previous, unrelated papers.

The trial is a waste of money and gives false hope to desperate families, says Paolo Bianco, a stem-cell researcher at the University of Rome and one of the scientists who says that Vannonis 2010 application to the US patent office does not stand up to scrutiny.

I am not surprised to learn this, says Luca Pani, director-general of the Italian Medicines Agency (AIFA), which suspended operations at the Brescia-based laboratories of Vannoni's Stamina Foundation in May 2012, after inspectors concluded that the labs would not be able to guarantee contamination-free preparations of stem cells. Inspectors were not shown systematic methodologies or protocols. We saw such chaos there, I knew that a formal method wouldnt exist, he says.

But questions raised over the patent that underpins the methodology needed for the trial could be political dynamite.

Well over 100 people with conditions ranging from Parkinson's to motor neuron disease to coma nearly half of them children have already signed up to participate in the government-sponsored trial, despite there being no published evidence that the therapy could be effective.

The Stamina Foundation has been given permission to treat more than 80 people on compassionate grounds since 2007, and Vannoni who has not published follow-up data on patients says that hundreds more were lined up waiting for treatment when the lab's operations were suspended. Supporters held angry demonstrations up and down Italy earlier this year.

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Italian stem-cell trial based on flawed data

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