EMA warns against unproven therapies

(ANSA) - Rome, April 29 - The European Medicines Agency (EMA) has sounded the alarm about the use of cell-based therapies that are promoted as being miracle cures but, in fact, are often unproven and unauthorized.
    Serious Risks.
    Some health facilities are offering these therapies in Europe via advertisements on the Internet.
    Patients desperately looking for cures for a variety of illnesses are often lured to them, but "these treatments can pose serious risks to patients for little or no benefit" warned the EMA's Committee for Advanced Therapies (CAT).
    The committee said it has drafted a document in response to "individuals, companies and hospitals promoting unproven cell-based therapies as cures for a broad range of conditions including cancer, cardiovascular diseases, autism, cerebral palsy, muscular dystrophy and vision loss".
    Growing Phenomenon.
    Francesca Ceradini, the director of the Osservatorio Terapie Avanzate (Advanced Therapies Observatory), said that this was "a growing phenomenon that is increasingly within reach.
    "Before, the journeys of hope (for cures) used to be to India or China, but today the destinations are in Europe and the United States too," she said. Source of Hope.
    Cell-based therapies are treatments using cells from the patient or a donor. These are used to regenerate tissue or organs and these techniques are also a source of hope for those examining possible treatments for COVID-19. The cells are manipulated in a laboratory (cultivated), genetically modified, or used for a different essential function to the original one.
    They are regulated in the EU as medicinal products and the EMA's Committee for Advanced Therapies works to ensure "timely access to these potentially life-changing treatments".
    Web Adverts.
    Alessandro Aiuti, the Deputy Director of the TIGET genetic therapy institute and a CAT member who was involved in drafting the document, told ANSA that the EMA's concern stemmed from adverts on the Internet.
    "We have received reports of adverts on the websites of clinics in several European Union countries that offer treatments sold as miracle cures based on mesenchymal cells, wrongly called stem cells, for example, for the treatment of Alzheimer's, with no scientific basis and with no proof of effectiveness," 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 few approved cellular therapies in Europe.
    "Many are being tested and the rest amounts to a jungle of unproven treatments," she said.
    "In the USA alone there are 700 private clinics that sell them at a very high price.
    "But there are others in Europe, especially in the east, in Switzerland and perhaps in Italy too". Side Effects Can Be Fatal.
    The EMA's statement said that patients using unproven or unregulated cell-based therapies "have reportedly suffered serious, sometimes fatal, side effects including infections, unwanted immune reactions, tumour formation, loss of vision and bleeding in the brain".
    The EMA said that, in order to protect the public, "well designed clinical trials on the safety and benefits of cell-based therapies are essential.
    "Patients or their families who are considering cell-based therapies should ask their healthcare professional about the benefits and risks of the treatment and which authority has approved it".