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Dodgy Data Underpin Stem Cell Trial

The patent application behind a controversial Italian treatment for neurodegenerative disease may contain duplicated images.

By | July 3, 2013

FLICKR, BRIAN TURNERItalian scientists have criticized a planned government-funded trial of an untested stem cell therapy. Now an investigation by Nature reveals that the US patent application for the treatment method appears to contain images duplicated from previously published scientific papers that are not related to the controversial stem cell therapy.

The stem cell treatment is purported to work by transforming stem cells from a patient’s own bone marrow into nerve cells—even though scientists generally do not consider this to be possible. “In fact, no one has ever been able to convincingly show that bone marrow cells can be converted into nerve cells,” Elena Cattaneo, a stem cell researcher at the University of Milan, told Nature.

The treatment’s maker, the Stamina Foundation, has not produced details of how the cells are prepared except for those provided in the patent application. The treatment became the center of controversy after patients began to use it even though it had not been approved. When the Italian government ordered the treatments halted, some citizens began to lobby the government to allow “compassionate use” of the stem cells. The Italian government ultimately let a few terminally ill patients continue treatment but banned others from beginning the therapy. However, the Italian Senate also allocated €3 million ($3.9 million) for a clinical trial.

More than 100 people have signed up for the trial, which was supposed to start July 1 but has been delayed because Davide Vannoni, head of the Stamina Foundation, has failed to provide documentation of his methods for preparing the stem cells.

Now, Nature reports that Vannoni’s patent contains images taken from two papers published by Russian and Ukrainian scientists in 2003 and 2006. The 2003 paper, like Vannoni’s patent, was about attempting to convert bone marrow stem cells into nerve cells. But the conditions of the pictured cells do not match the conditions described in Vannoni’s patent, according to an author of the image.

Vannoni did not return phone calls or emails from Nature. Paolo Bianco, who studies stem cells at the University of Rome, told Nature that the trial of the treatment was “a waste of money and gives false hope to desperate families.”

Vannoni’s patent application was rejected by the US Patent Office, although he could resubmit.

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