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".
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