the Italian Health Minister Beatrice Lorenzin
Ministry of Health
ROME- The controversy surrounding unproven stem cell therapy in Italy may be ending. Minister of Health Beatrice Lorenzin Italy announced yesterday that the Endurance, the non-profit foundation based in Turin who developed the treatment, will not be permitted to test it on humans, at least not in Italy.
The method known as Endurance is a treatment based on stem cells from bone marrow that allegations President Davide VANNONI Stamina can grow new neurons in specific conditions and thus cure several neurodegenerative diseases. However, while thousands of patients still maintain stamina and treatment, scientists believe the method has no scientific basis. In May, the government passed a law providing € 3 million for the treatment to undergo a clinical trial. But in July, Endurance Lorenzin ordered to release its scientific dossiers for consideration for treatment by a committee of scientific experts to assess whether the method is safe and effective enough to enter human trials.
On September 12, the media reported that experts had unanimously rejected the method, although the reasons for rejection are not disclosed. Now a decree of the Ministry of Health states that the rejection by the Committee was based on the following:
-
An "inadequate description of method, "because of the absence of a description of how cells should give rise to new neurons
-
on" the lack of quality controls on cells " , which makes treatment difficult to reproduce, so not guarantee the safety and efficacy of the product
-
on the "potential risks, due to the lack of a clear plan selection, screening and testing donors of cells, causing the lack of exclusion of risks from communicable diseases, such as HIV-1 and HIV-2. "
-
d other risks of serious awareness. ie encephalomyelitis, and the risk of injection of bone material in the nervous system
At a press conference yesterday, Lorenzin said, "I ' wish the story to have a different ending, but Endurance method are not eligible for the trial. "Vannoni Stamina says science Insider that" the grounds for refusal are totally unfounded. "The stem cell community
Italian, which opposed the method from the beginning, gave a sigh relief. "After the scientific world arose, the right decision was ultimately made," said Michele de Luca, director of the Center for Regenerative Medicine "Stefano Ferrari" in Modena., Italy "method does not exist. It has no scientific basis and could be dangerous. "
But the story does not end there dozens of patients still receive Endurance method in a hospital in Brescia and hundreds more are on a waiting list of their appeal to the Italian courts for the right to be treated by Stamina.
it is now unlikely that a formal clinical trial will ever take place, it remains unclear whether patients will continue to receive treatment. Lorenzin said Science Insider that the matter rests with the Minister of Justice, not health. "I wonder how the judges will continue to impose access treatment after the strong position taken by the Ministry of Health, "says de Luca.
Vannoni said the Endurance biologists are preparing to submit a paper to a peer-reviewed journal. He added that "the health minister of an African country has already given the green light to human experiences for treatment in this country."
0 Komentar