Italian government sponsors dubious clinical trial

UPDATE 19/10/13 The trial was halted before recruiting any patients.
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The Italian government have agreed to oversee a €3 million stem cell trial. Sadly, the researcher is so dodgy he could give Stanislaw Burzynski a run for his money.

Davide Vannoni (who is not a doctor, but a psychology teacher) has developed his own brand of stem cell therapy which he claims can cure fatal and incurable illnesses. The cells are not manufactured according to safety standards and there is no published evidence that the therapy could ever be effective.

Well over a hundred people, including children, are due to participate in the trial. They have conditions including Parkinson’s, motor neurone disease and coma.

Last week, Nature reported that Vannoni’s trial method is based on flawed data. Their  investigation suggests that images used in a 2010 US patent application, on which the method is said to be based, are duplicated from previous, unrelated papers.

How many red flags is that so far?

There are more.

Lone Maverick

Vannoni set up the Stamina Foundation and developed Stamina Therapy himself. He works without oversight by independent parties, insisting his therapy can only be prepared by his own people, without using good manufacturing practice.

Results not reproduced by independent research

When doctors in Trieste investigated Vannoni’s therapy, they found that the treatment did not change the course of the disease.

Vannoni dismissed their work because they had used not used his exact cocktail of cells.

Unevidenced mechanism of action

Mesenchymal stem cells found in bone marrow cells can differentiate into bone, fat or cartilage cells. There is no convincing evidence that they can develop into  nerve cells, or indeed any other type of cell, yet Vannoni’s therapy relies on this mechanism.

Trouble with the authorities

Vannoni moved to San Marino in 2007  because “the rules were not so strict”.

He then moved to Trieste and then to Brescia, following investigations by a Turin prosecutor, Raffaele Guariniello, who concluded that Vannoni’s operation could be “dangerous to public health”.

In May 2012, the Italian medicines regulator (AIFA) and the health ministry’s national institute (ISS) investigated the Brescia lab and closed it down, stating that the facilities could not be trusted to produce contamination free preparations. Inspectors were not shown methodologies or protocols.

Lack of transparency

Luca Pani, director general of the AIFA,  told Nature:

We saw such chaos there, I knew that a formal method wouldn’t exist

Last year, the US Patent Office issued a ‘pre-final’ rejection of Vannoni’s patent, noting (among other things) that the application included insufficient details on methodology.

The clinical trial, due to begin on 1st July, has been delayed because Vannoni has postponed commitments to reveal his method. Three times.

Criticism from experts

On 15th March, a group of 13 Italian stem cell researchers published an open letter to Italy’s Minister of Health, Renato Balduzzi, asking him to shut down the Stamina Foundation’s treatments.

Elena Cattaneo, a stem cell researcher of the University of Milan, described Stamina therapy as alchemy.

Paolo Bianco, a stem cell researcher at the University of Rome said the trial was a waste of money and gives false hope to desperate families.

Irving Weissman, director of California’s Stanford Institute for Stem Cell Biology and Regenerative Medicine, says that the Italian government would be unwise to support a trial with so little evidence of efficacy.

Campaigning patients

Yet on 21st March, Balduzzi bowed to pressure from patients and their families and decreed the treatment could continue in 32 terminally ill patients.

They had turned to the legal system, asking for treatments to continue as compassionate use. Many courts concluded it was a patient’s right to receive treatment (although some did not) and in some cases, the Brescia lab once again supplied cells.

They turned to the media. In February, the television programme The Hyena reported that children with incurable diseases were being denied treatment. Italian celebrities rallied round in a call to relax the rules.

On 23rd March, hundreds protested in Rome, including a naked woman with pro-Stamina slogans painted on her skin.

Vannoni said the publicity has won him 9000 new patients and that he hopes further modifications to the law will allow him to expand the therapy.

In the Italian media, the debate has continued to rage. The revelation that the Stamina trial is based on flawed data made the front pages of Italian newspapers and featured on television and radio talk shows.

Response to critics

According to Nature, Vannoni’s response tends to be indirect, stating that critics have vested interests or that they want to stop him from helping those who would otherwise die.

Between 26th June and the publication of their exposé on 2nd July, Nature made repeated attempts to contact Vannoni by email and telephone for comment, but received no response. Likewise, the Stamina Foundation did not respond to emails.

False hope

With no transparency of the methods, no theoretical basis for the mechanism of action, no evidence of efficacy and no guarantee of safety, there are no scientific or ethical reasons to justify the Stamina trial.

Stem cells could have the potential to treat currently incurable diseases. For this reason, there has been a proliferation of stem cell quacks, claiming to cure any condition you care to name.

In jumping on the bandwagon, Vannoni is misleading the desperate and the vulnerable. He offers nothing but false hope.

In allowing the trial to go ahead, the Italian government are not only failing to support real stem cell research, they are also bringing this important and promising field into disrepute.

Related articles

Stem-cell ruling riles researchers Alison Abbott, Nature, 26/03/13

Italy pushes on with controversial stem cell therapy Laura Margottini, New Scientist, 29/03/13

Undermining the regulation of stem cell therapies in Italy: A warning for the future? David Gorski, Science Based Medicine, 06/05/13

Italian stem-cell trial based on flawed data Alison Abbott, Nature, 02/07/13

Trial and error Editorial, Nature, 09/07/13

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3 responses to “Italian government sponsors dubious clinical trial

  1. Shades of the Di Bella therapy experience:
    http://bit.ly/137zcjx
    http://bit.ly/18TrP3q

  2. I really want clinical trials for stem cell therapies to succeed because I believe it will help a lot of patients. Its just sad to hear that there are some who uses it for their personal reasons and make false promises.

  3. Pingback: Cellule staminali, cura con mille ostacoli | Eyes on World

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