For months we hear of the case Stamina but now you turn seriously dispute between David Vannoni, president of Stamina Foundation, the Ministry of Health and the ‘ISS.
Monday, May 20 in fact the room will be discussed the decree to start trials on the protocol stamina so far only in the hands of this foundation, in fact.
The Minister of Health Lorenzin, he asked forcefully Stamina Foundation to participate and cooperate in the trial to be followed accurately by the ISS supported by the Ministry of Health has found that 3 million euro to bear the burden of such research.
‘s response Vannoni not long in coming and, unfortunately, is not what was expected.
Vannoni in fact states:
“Stamina will deliver the method” in the clear “to the Ministry of Health and ISS only if the test can be done in non-pharmaceutical laboratories, ie those for transplants. Stamina may not be reproduced in pharmaceutical laboratories, GMP (Good manufacturing practice, standards of good manufacturing practice) because all culture media used by the protocol Stamina are not GMP and modify them to adapt to a pharmaceutical production would create a different cellular product that would never been applied in humans. ” It also explains Vannoni, “the difference process is completed during the last three hours before the infusion and must, therefore, be carried out in the hospital in which it takes place inoculation. This could be done in the laboratories of transplant centers present in the hospitals in which the therapy is to prevent dangerous movements in patients in serious condition. ” But here’s the final thrust of V annoni “the state could risparmiarseli, as they are not for Stamina who work for free but for consultants who will spread the assessment protocols.” Other problems are the costs of GMP laboratories. “In the laboratories Gmp soaring 12-fold, rising from € 5,000-8,000 of a cell line produced by the method Bunting” about 60 thousand euro. “
According Vannoni moreover, GMP workshops, given their limited size and availability of beds, can provide treatment to a limited number about one hundred patients a year while the cell factory could go well above curing therefore the need for a very large number of people waiting for this treatment.
Lorenzin However, the minister did not give up trying to give as much reassurance Vannoni but a nice racing risk, as the same minister said, because the protocol stamina seems somewhat inaccurate and “mysterious” according to the entire scientific community so that some characters such as the doctor Michele De Luca, director of the Center for Regenerative Medicine “Stefano Ferrari” of ‘ University of Modena and Reggio Emilia, one of the cell-factory authorized for the manufacture of advanced therapy based on stem cells, he doubts even of the ‘existence of such a protocol as it claims that all stem cells, includin g mesenchymal cells (used in the protocol stamina), are all treated the same way.
Dr. De Luca also points out that the lack of clarity of such a protocol has already brought European and American patent offices to reject the patent application.
We are all waiting then the legislative decree on Monday, hoping soon to shed light on a story so important to health.
of Editor
May 19, 2013
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