Tuesday, June 18, 2013

Signed the decree for experimentation care Stamina - ANSA.it

Into” I signed the decree for the start of the trial of the method Stamina” that uses stem cells with the protocol developed by David Vannoni doctor.” This was confirmed by the Minister of Health, Beatrice Lorenzin. Would it be so ‘all ready to go as expected with the trial on July 1.

Into “The Protocols of the boot for the clinical trial of the method Stamina stem cells are parties, I have already signed the decree and is preparing the cell-factory. later than July 1st we will be ready – had announced early in the morning the minister – . Hopefully in positive results. “

Into “It seems very strange. Yet there have been asked to deliver our protocol, including fixing the date of the first meeting” with the institutions responsible for the definition of the trial,” said the president of Stamina Foundation , David Vannoni, which has developed the method Bunting stem cell therapy.

Into “We are pleased – said Vannoni – that the Minister of Health has signed the decree, because this is an indication of willingness to go ahead with testing, but it seems very strange that Stamina has not yet been convened to a meeting. ” The date of 1 July for the start, as defined, of the trial, found Vannoni, “is very close and from our side there is full availability to meet us to understand the characteristics that the trial will take.” At the moment, however, he added, “we know nothing: neither how many patients will be involved, or what cell-factory produce stem cells, neither of which diseases will start experimenting with our method.” From the President Foundation of Stamina Finally, a clarification: “I reiterate though – he concluded – that we are ready to provide our protocol of care only under certain conditions, from the fact that the production of stem cells can be made by biologists of Stami na “.

Into The decree signed by the Minister expected to be a scientific committee – of which will be part of National Institute of Health, the National Transplant Center and Agency of the drug, as well as various experts – to decide the criteria and details of the testing of the method Stamina. The Scientific Committee will then determine for which diseases will start experimenting with the method Stamina, which should be the criteria for selection of patients involved and the mode of production of stem cells.

Into The order signed by the Minister of Health is a decree of the rules already agreed on by the Parliament. On 15 May, in fact, the Social Affairs Committee of the House approved an amendment ‘key’ to the decree Balduzzi that addresses the issue of compassionate care, giving the green light to the experimentation of advanced therapies based on mesenchymal stem precisely from those used method of the Foundation Stamina. The trial is sponsored by the Ministry of Health with the Agency Drug Agency (AIFA), National Institute of Health (ISS) and the National Transplant Center (NTC), and the only pole of patient safety.

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