Following the leak last month of a treatment protocol for a controversial stem-cell therapy earmarked for a clinical trial to be sponsored by the Italian government, further leaks from police investigations and other revelations are emerging daily about the activities of the trial’s sponsor, the Stamina Foundation.
The foundation has treated scores of seriously ill patients with the therapy since 2007, and its president Davide Vannoni has whipped up a frenzy of support among the families of dying patients to whom he claims to offer a cure. He has also so far managed to maintain political support.
Now, however, Stamina’s case appears to be unravelling.
On 12 December the newspaper La Stampa published an article describing, based on police witness accounts, how the Stamina Foundation’s roots lay in a call centre run by Vannoni, called Cognition Turin. After experiencing a partial facial paralysis in 2004, he went to Russia seeking a stem cell‒based treatment. He brought back with him two Ukrainian scientists and set up a small lab for them in Cognition’s basement, described by a police witness who had worked there as tiny and dark, with no ventilation. The lab was equipped with a couple of fridges and a few microscopes on a shelf, said the witness. Patients began to arrive from all over Italy.
In its early years, Stamina enjoyed political protection in the Piedmont region, which agreed to provide it with a grant of half a million euros to develop its stem-cell activities. But the region dropped the plan at the last minute after police in Turin began investigating possible fraud in relation to the proposed Piedmont grant. That investigation led to Vannoni being indicted for attempted fraud last month.
Patients were charged tens of thousands of euros for treatment, which consisted of extracting stem cells from their bone marrow, manipulating them in vitro (ostensibly to turn them into neurons) and delivering them back into the blood stream or spinal cords of the same patients.
Police are investigating the fate of 68 patients, or their families, who claim they were damaged by Stamina treatment.
On 9 January, La Stampa published an interview with Milena Mattavelli, whose husband died within eleven days of his first Stamina injection, though doctors had expected him to live with his incurable disease, multiple system atrophy, for several more years. Mattavelli said she paid Stamina €50,000 in cash and got no receipt.
In another revelation, the father of a young child treated by Stamina told the police investigators that he also paid €50,000 and had been told by Stamina to transfer the money using a description ‘contributions, donations and offerings’ because the procedure was illegal in Italy. His daughter’s condition, not named in the newspaper article, did not improve.
Nicola De Matteis, whose daughter was born with encephalopathy, ran out of money after several treatments and was told by Stamina’s physician Marino Andolina to make his wife earn it through prostitution, according to an article in La Stampa on 13 January. Andolina did not respond to an email requesting comment.
Meanwhile the University of Udine, where Vannoni had been an assistant professor in psychology, has revoked his teaching contract, saying his “role in the university is no longer compatible with his other activities as president of the Stamina Foundation.” Vannoni says he was leaving anyway to join an online university.
And more top scientists have distanced themselves from diabetes expert Camillo Ricordi from the University of Miami in Florida, who has frequently voiced support for Stamina, and who holds a potentially influential position in Italy as the new president of RiMED, a translational-medicine institute being established in Sicily whose mandate includes development of cellular therapies. Ricordi had also offered to test Stamina cells in his Miami laboratories, although on 13 January he said he would “postpone” the offer.
Immunologist Alberto Mantovani, scientific director of the Clininal Institute Humanitas IRCCS in Milan, and cell biologist Tullio Pozzan from the University of Padua have resigned from RiMED’s scientific board, citing concern that Ricordi has declined to condemn Stamina. They join cancer researcher Carlo Croce from the Ohio State University in Columbus, who resigned for the same reason at the end of December. The scientific board is now left with just three (non-Italian) members.