Researchers call on govt to halt Stamina stem-cell treatment

Health minister calls for protocol

Researchers call on govt to halt Stamina stem-cell treatment

Rome, July 3 - Italian researchers on Wednesday called on the health ministry to stop supporting a controversial stem-cell treatment after international science journal Nature slammed it as ineffective. Health Minister Beatrice Lorenzin responded saying the promoter of the Stamina therapy needed to show results of its clinical trials and a detailed protocol. "Nature's report against the Stamina method is very serious and, most of all, raises great concern," said Lorenzin, calling on Davide Vannoni, the president of the Stamina Foundation which developed the therapy, to hand over a protocol without further ado. Paolo Bianco, a top international expert at Rome's La Sapienza University on mesenchymal stem cells, which are used in the therapy, had earlier called on the government to stop the treatment which "should be legally sanctioned by the government and immediately banned from all public hospitals of the national health service". The controversial Stamina therapy questioned by Nature uses the mesenchymal stem cells from bone marrow that differentiate into bone, fat and connective tissue to treat terminally ill patients. Developed by the Brescia-based Stamina Foundation, a psychologist at the University of Udine, the treatment was repeatedly banned until the Italian health ministry in March said the therapy could continue in 32 terminal patients, most of them children, although the stem cells used for the treatment are not manufactured under the country's legal safety standards. Responding to criticism on Wednesday, Vannoni wrote on his Facebook page that Stamina needed "greater guarantees of objectivity" before it could present trial results and a protocol, as requested by parliament. Though the compassionate use of the therapy was only sanctioned in March for patients who were already being treated with the Stamina method, an increasing number of patients are bringing the matter to court to get the treatment. Judges across Italy have in the past few months both ruled in favour and against a patient's right to have the treatment. In Italy, the compassionate use of yet-to-be-approved therapies is allowed in certain instances for terminal patients in which cases health authorities must provide them for free. But on Wednesday another expert, Michele De Luca, director of the 'Stefano Ferrari' centre for regenerative medicine at the University of Modena and Reggio Emilia said that, as highlighted by Nature, "this experimentation, which had initially appeared as unavoidable, has no sense now and should be avoided". Vannoni says he developed the therapy after receiving a stem-cell treatment for a virus-induced facial paralysis in Russia in 2004. He told Nature that the publicity around his method has attracted 9,000 new patients. The psychologist said after his treatment he invited a Russian and a Ukrainian scientist to Turin to work on the treatment and claims Stamina has since treated about 80 people, including patients with Alzheimer's and Parkinson's disease. He has not published the details of his therapy. His lab is now based in Brescia, where an inspection by the Italian Medicines Agency and the health ministry's Institute of Superior Health reported inadequate conditions.

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