Italy’s minister of health has announced that the Italian government will not permit human clinical trials of a controversial stem cell therapy. The Stamina Foundation, a Turin-based non-profit founded by Davide Vannoni, has been at the centre of a months-long battle to secure legal permission to provide the treatment, which many scientists believe has no scientific basis.
The treatment involves removing the patient’s bone marrow cells, conducting some in vitro manipulations, and reintroducing the manipulated cells back into the patient. Vannoni claims to be able to cause bone marrow cells to differentiate into nerve cells, which would aid in the treatment of neurodegenerative diseases such as ALS, Parkinson’s, and Alzheimer’s. As a result of these claims, thousands of people support Stamina’s treatment methods, despite their questionable scientific value.
Many stem cell scientists have dismissed Vannoni’s claims. One anonymous source told the journal Science that the theory behind the treatment is “unclear and scientifically inconsistent,” and stem cell researcher Elena Cattaneo called it “alchemy.”
Scientists have also been suspicious of the secrecy surrounding the treatment. Vannoni refuses to reveal detailed information about the treatment, and the only document publicly available is the U.S. patent application, which was rejected by the U.S. Patent Office, for being too vague.
An investigation carried out by the journal Nature found that Stamina’s U.S. patent application contained images lifted without context or attribution from unrelated papers published by a Russian and Ukrainian team.
Under Italian law, unproven stem cell treatments can be provided to terminally ill patients without other options – provided that certain safety standards are maintained. Earlier this year Italy’s previous health minister, Renato Balduzzi, responded to pressure from Stamina supporters by proposing a law that in its original version would have allowed the treatment of thousands of patients without the prior performance of clinical trials.
The Italian Senate approved an amended bill that allowed Stamina to continue treating the patients they already had, but prevented them from taking on new patients. It also provided three million euros for a clinical trial of the treatment. According to Cattaneo, “this will probably be the first time that a parliament orders a clinical trial.”
In July, the minister of health ordered Stamina to provide scientific information on their treatments to a committee of scientific experts to assess the safety and effectiveness of this method for human trials. By early September, Stamina’s treatment methodology had been unanimously rejected, primarily for being vaguely described and unsafe.
Vannoni told reporters from the journal Science that “the reasons for rejection are totally unfounded.” He expressed surprise that the panel did not look at the records of any of his current patients. “They are doing very well,” he said.
Vannoni also impugned the impartiality of the panel, most of whose members expressed an unfavourable opinion of his treatment before they were selected. Although Stamina will not be able to carry out human trials in Italy, Vannoni claims that the minister of health for an unidentified African country has approved the tests. He also claims that one European and one Asian country are interested in the treatment.
Despite all of the recent events, there are still many patients being treated by Stamina in a Brescia hospital, while around 100 people have appealed to Italian courts for the right to be treated by Stamina.