Investigation casts doubt on controversial Italian stem cell treatments

Davide Vannoni, head of the Stamina Foundation in Turin, Italy, and pioneer of a controversial stem cell therapy, has once again hit the headlines amid allegations of poor research methodology. An investigation by Nature has revealed that the planned €3 million Italian government-sponsored clinical trial of a stem-cell treatment is based on unsound data.

The stem cell treatment in question (reported in BioNews 707) relies on differentiating bone-marrow cells into nerve cells in order to treat neurodegenerative conditions conditions. Vannoni has already faced criticism on grounds of safety and efficacy. Now, further evidence has emerged casting doubt on the premise of this therapy.

Bone-marrow cells have been shown to successfully differentiate into bone, fat or cartilage cells, however 'no-one has ever been able to convincingly show that bone-marrow cells can be converted into nerve cells', says Professor Elena Cattaneo, director of the Laboratory of Stem Cell Biology and Pharmacology of Neurodegenerative Diseases at the University of Milan.

Vannoni has been slow to reveal details of his method, instead directing queries to an application in 2010 to the US Patent and Trademark Office (PTO). The Nature investigation suggests that key parts of the method cited in this application, including a micrograph, are replicated from a Russian and Ukrainian research paper published in 2003. Although the Russian and Ukrainian paper also investigated differentiating bone marrow cells into nerve cells, the research was carried out under markedly different experimental conditions.

Elena Schegel'skaya, a molecular biologist at the Kharkiv National Medical University and co-author of the 2003 paper has confirmed duplication from the 2003 paper. She points out a further micrograph is apparently duplicated from a 2006 paper that she published in Ukrainian Neurosurgical Journal. The US PTO rejected Vannoni's application (albeit with leave to resubmit), citing inter alia insufficient details on methodology.

The clinical trial, which was to begin 1 July 2013, has been delayed pending the submission documents detailing the scientific method to the government-appointed committee that will oversee the administration of the trial. This is not the first time Vannoni has delayed the delivery of these documents.

Neither Vannoni nor the Stamina Foundation has commented directly on the findings of Nature's investigation. However, Vannoni has posted on his Facebook page about the necessity of 'greater guarantees of objectivity' before presenting details of trial results and a full research protocol, as requested by the Italian parliament.

A Nature editorial following the investigation states that: 'Movement of any therapy into a clinical trial requires much more transparency. It also needs a solid theoretical basis for why it should work, backed by scientific evidence, either published or presented confidentially to the appropriate authority, in this case the Italian Medicines Agency. Vannoni has not provided this'. This sentiment has been echoed by others; Dr Irving Weissman, director of the Stanford Institute for Stem Cell Biology and Regenerative Medicine in California, has questioned the wisdom of the Italian government in supporting this trial.

The Huffington Post (Italy) reports that Vannoni has defended his work and responded to the Nature article in the post on his Facebook page. It reports Vannoni as saying there are hundreds of people in Brescia waiting to be treated by Stamina's methods.