ROME—The controversy surrounding an unproven stem cell therapy in Italy may be drawing to a close. Italy’s Minister of Health Beatrice Lorenzin announced yesterday that Stamina, the Turin-based nonprofit foundation that developed the treatment, will not be allowed to test it on humans—at least not in Italy.
The so-called Stamina method is a treatment based on bone marrow stem cells that Stamina’s President Davide Vannoni claims can grow new neurons under specific conditions and hence cure several neurodegenerative diseases. However, while thousands of patients still support Stamina and its treatment, scientists believe the method has no scientific basis. In May, the government passed legislation providing €3 million for the treatment to undergo a clinical trial. But in July, Lorenzin ordered Stamina to release its scientific files concerning the treatment for scrutiny by a committee of scientific experts to assess if the method is safe and effective enough to enter human trials.
On 12 September, media reported that the experts had unanimously rejected the method, although the reasons behind the rejection were not released to the public. Now, a decree from the Ministry of Health states that the committee’s rejection was based on the following:
An “inadequate description of the method,” due to the lack of a description of the way cells should give birth to new neurons
On “the lack of quality controls on cells,” which makes the treatment hard to replicate, thus not guaranteeing safety and efficacy of the product
On the “potential risks involved, due to the lack of a clear plan of selection, screening and testing of the cells’ donors, resulting in the lack of exclusion of risks related to transmissible illnesses, such as HIV1 and HIV2.”
On other risks of serious sensitization. i.e. encephalomyelitis, as well as the risk of injection of bone material at the level of the nervous system
At a press conference yesterday, Lorenzin said: “I would have liked this story to have a different ending, but the Stamina method is not eligible for the trial." Stamina’s Vannoni told ScienceInsider that “the reasons for rejection are totally unfounded.”
The Italian stem cell community, which has opposed the method from the beginning, gave a sigh of relief. “After the scientific world stood up, the right decision has finally been taken,” says Michele De Luca, director of the Centre for Regenerative Medicine “Stefano Ferrari” in Modena, Italy. “The method does not exist: It has no scientific basis and could be dangerous.”
But the story does not end there. Dozens of patients are still receiving the Stamina method in a hospital in Brescia and a hundred others are on a waiting list following their appeal to Italian courts for the right to be treated by Stamina.
While it is now unlikely that a formal clinical trial will ever take place, it remains unclear whether patients will continue to receive the treatment. Lorenzin told ScienceInsider that the matter lies with the Minister of Justice, not Health. “I wonder how the judges will continue to impose access to treatment after the strong position taken by the Ministry of Health,” De Luca says.
Vannoni said that Stamina’s biologists are preparing to submit a paper to a peer-reviewed journal. He added that “the Minister of Health of an African country has already given the green light to human experiments for the treatment in that country.”