(ANSA) - Rome, April 29 - The European Medicines Agency (EMA)has sounded the alarm about the use of cell-based therapies thatare promoted as being miracle cures but, in fact, are oftenunproven and unauthorized.Serious Risks. Some health facilities are offering these therapies in Europevia advertisements on the Internet. Patients desperately looking for cures for a variety ofillnesses are often lured to them, but "these treatments canpose serious risks to patients for little or no benefit" warnedthe EMA's Committee for Advanced Therapies (CAT). The committee said it has drafted a document in response to"individuals, companies and hospitals promoting unprovencell-based therapies as cures for a broad range of conditionsincluding cancer, cardiovascular diseases, autism, cerebralpalsy, muscular dystrophy and vision loss".Growing Phenomenon. Francesca Ceradini, the director of the Osservatorio TerapieAvanzate (Advanced Therapies Observatory), said that this was "agrowing phenomenon that is increasingly within reach. "Before, the journeys of hope (for cures) used to be to Indiaor China, but today the destinations are in Europe and theUnited States too," she said. Source of Hope. Cell-based therapies are treatments using cells from thepatient or a donor. These are used to regenerate tissue or organs and thesetechniques are also a source of hope for those examiningpossible treatments for COVID-19. The cells are manipulated in a laboratory (cultivated),genetically modified, or used for a different essential functionto the original one. They are regulated in the EU as medicinal products and theEMA's Committee for Advanced Therapies works to ensure "timelyaccess to these potentially life-changing treatments".Web Adverts. Alessandro Aiuti, the Deputy Director of the TIGET genetictherapy institute and a CAT member who was involved in draftingthe document, told ANSA that the EMA's concern stemmed fromadverts on the Internet. "We have received reports of adverts on the websites ofclinics in several European Union countries that offertreatments sold as miracle cures based on mesenchymal cells,wrongly called stem cells, for example, for the treatment ofAlzheimer's, with no scientific basis and with no proof ofeffectiveness," he said. "This takes us backwards to the mistakes made with the(discredited) Stamina (therapy)." Few Approved Cell Therapies. Ceradini said that, at the moment, there are very fewapproved cellular therapies in Europe. "Many are being tested and the rest amounts to a jungle ofunproven treatments," she said. "In the USA alone there are 700 private clinics that sellthem at a very high price. "But there are others in Europe, especially in the east, inSwitzerland and perhaps in Italy too". Side Effects Can Be Fatal. The EMA's statement said that patients using unproven orunregulated cell-based therapies "have reportedly sufferedserious, sometimes fatal, side effects including infections,unwanted immune reactions, tumour formation, loss of vision andbleeding in the brain". The EMA said that, in order to protect the public, "welldesigned clinical trials on the safety and benefits ofcell-based therapies are essential. "Patients or their families who are considering cell-basedtherapies should ask their healthcare professional about thebenefits and risks of the treatment and which authority hasapproved it".

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EMA warns against unproven therapies - English - Agenzia ANSA

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