An untested method of cell therapy is prohibited
Clinical trials of questionable cell therapy banned in Italy
ABC Magazine based on ScienceInsider: Italy Blocks Use of Controversial Stem Cell TherapyStamina Foundation is a non–profit organization headquartered in Turin, Italy.
This organization has developed and has already started using drugs for the treatment of neurodegenerative diseases based on bone marrow stem cells. Thousands of patients support this organization, and hundreds are on treatment waiting lists. However, despite this, the treatment method proposed by the company did not pass the registration procedures accepted for medicines. Moreover, no clinical trials have been conducted on it.
According to the Minister of Health of Italy Beatrice Lorenzin (Beatrice Lorenzin), they will not be held in Italy. Earlier this year, the state allocated 3 million euros to carry out the required tests. However, later, the ministry requested a scientific dossier of the drug, and handed it over to independent experts for analysis. Experts unanimously rejected the documents they saw. Firstly, as it turned out, the method is described inadequately, including it is completely unclear exactly how bone marrow stem cells will give rise to new neurons. Secondly, the quality control of the drug is insufficient to exclude doubts about its reliability and safety. From the description of the method, it is impossible to understand the process of selecting bone marrow donors, which entails the danger of transmission along with donor material of viruses such as, for example, H1 and H2.
Italian scientists specializing in regenerative medicine welcomed this decision. The Stamina Foundation itself believes that the grounds for refusal are not justified. The company is preparing for publication materials describing the effectiveness of the drug. The first clinical trials will be held in one of the African countries, where permission has already been obtained to conduct research. Meanwhile, patients are going to challenge the ministry's decision in court. It is unclear what will happen to those who are currently receiving treatment. According to Lorentzin, the decision remains with the Ministry of Justice, since medicine has already said its word.
Portal "Eternal youth" http://vechnayamolodost.ru16.10.2013