Once upon a time there were journeys of hope, now illicit treatments are also carried out at home: in Italy stem cell-based scams arrive directly “at the patient’s bedside”
After almost 15 years from the Stamina case, In Italy the specter of scams with stem cell-based pseudo-therapies returns to the detriment of patients and their families. It’s what emerged from an important investigation by Presa Diretta which aired last night, Sunday 1 March, and during which Osservatorio Terapie Avanzate was mentioned as an authoritative point of reference in Italy for correct information on advanced therapies and its constant commitment to monitoring the phenomenon of therapeutic scams and for the protection of patients.
Over the last twenty years we have heard about the so-called “journeys of hope”, patients with serious illnesses – often rare and incurable – and desperate families, ready to go abroad chasing the promise of miraculous therapies based on stem cells. Treatments without scientific validation sold at a high price for the most varied pathologies: from neurodegenerative diseases to tumors, from neuromuscular diseases to autism, but also for vision or hearing loss, up to pain therapy. A global business worth several billion dollarswhich Osservatorio Terapie Avanzate has carefully monitored over the years, also reporting the alarms that are regularly launched by regulatory bodies such as the European Medicines Agency (EMA) or the Italian Medicines Agency (AIFA).
“A growing phenomenon that is increasingly within reach. Previously, journeys of hope were made to India or China, today also to the United States and Europe”, he commented in 2020 Francesca Ceradiniscientific director of Osservatorio Terapie Avanzate, in an interview for ANSA reported on the Ministry of Health website.
And it is starting from this worrying context and thenumerous requests for information on the possibility of being treated with stem cells for the most disparate diseases that arrive in the editorial office every weekby patients, family and friends, who in 2022 Osservatorio Terapie Avanzate has created the “Anti-fraud handbook for stem cell-based therapies”. A guide to help patients and citizens in general to orient themselves and avoid baseless promises or outright scams that damage their wallets and health itself.The handbook is designed in ten points: a few but clear pieces of advice which can be applied when faced with proposals for stem cell-based treatments to understand whether they are therapies regulated and authorized in Italy, experimental therapies undergoing clinical trials or, more simply, dangerous scams.
As shown by the Presa Diretta service, the Vademecum is available to anyone who needs it and can be downloaded free of charge from the Osservatorio Terapie Avanzate website.
But what is the news that emerged from the Presa Diretta investigation? The phenomenon is taking new, increasingly dangerous forms. There is no longer any need to migrate abroad to access miraculous stem cells: private clinics bring them straight to your home, right “to the patient’s bedside”, to use clinical-scientific jargon. Therefore a real illicit trafficking of cellular pseudo-therapies administered outside of any regulated clinical context.
The Presa Diretta team has found it a group of self-styled “doctors” from Poland and Belarus who go to patients’ homes, upon payment of large sums, to inject mesenchymal stem cellspromising to alleviate suffering and halt the progression of very serious diseases that are currently incurable.
“ We paid around 19 thousand euros in advance with a bank transfer and after 10 days they arrived in Italy, at our house. Four people in single file, I will remember them forever. They spoke Polish,” says the wife of a patient suffering from amyotrophic lateral sclerosis (ALS) who stumbled upon the scam. “The first day they did it to him an intrathecal injection in the back the next day they returned to do the second part of the treatment: an IV of stem cell culture broth to strengthen the immune system.” Within three months the stem cells would enter the body to do their job, this was what the couple was told who were desperately looking for a cure for ALS – a very serious neurodegenerative disease for which today there is only a specific therapy for a small number of patients.Clinical improvements, obviously, did not arrive.
Stem cells are a pillar of regenerative medicine and research in this sector is vast and excellent in our country. But scientists don’t have a magic wand,serious and reliable research takes a long time and has very rigorous rules, and stem cell therapies authorized in Europe and Italy are very few: none are indicated for diseases such as ALS, multiple sclerosis, Parkinson’s or Alzheimer’s. Despite this, there are those who have no doubts about wanting to bet on unauthorized therapies, albeit in the early stages of the disease and going against the advice of specialists. An example is Emanuele, who was diagnosed with multiple sclerosis in 2020 and despite still having mild symptoms, is absolutely determined to have stem cell treatment.He did in-depth research by meticulously comparing the services offered by a series of private clinics, eventually choosing a Swiss one. Emanuele is aware of his choice and the risk: “mine is a bet, for multiple sclerosis stem cells are not a cure, they are a very strong supplement. If they work I will be very happy, if they don’t work I won’t have either my health or a new car. Patience!”
“The growing illicit trade in unapproved therapies is the symptom of a society that no longer recognizes science as a primary cultural reference”, he commentsJulius Pompiliusscientific director of the Monzino IRCSS Cardiology Center in Milan and President of the scientific committee of the Advanced Therapies Observatory. “ We need a deep and widespread work of dissemination of scientific cultureespecially among young people, to whom we are all called to contribute. Because real scientific progress and the protection of citizens’ health only arise from solid scientific foundations.”
“ The phenomenon of stem cell-based scams is becoming increasingly serious and insidious, ‘false hope’ is no longer sought outside the borders but arrives directly at home.A business that unfortunately leverages the gap between the availability of effective therapies and the needs of patients with very serious illnesses”, declares Francesca Ceradini. “We are talking about untracked treatments, without scientific validation in terms of safety and effectiveness, which are administered on Italian territory outside of any specific existing legislation.As an Advanced Therapies ObservatoryWe hope that the competent institutions and authorities will undertake to carefully monitor these cases and activate specific and timely actions to limit the risks and protect patients and families.”.
What to do to avoid scams based on unauthorized treatments? Where to look for information to protect yourself?To obtain reliable information you need to turn to official sources such as regulatory bodies, scientific societies, accredited hospitals. Furthermore, the reference patient associations for the various pathologies are often a precious source of information on new authorized therapies and on therapies under investigation.
In addition to these channels, for yearsOTA is at the service of patients, caregivers and all citizens seeking information on advanced therapies, including those based on stem cells. The Vademecum is a mini-guide, easy to consult, which in clear and simple language provides information on how to understand when you are faced with a scam.
The Vademecum can be downloaded for free:
Furthermore, OTA provides periodically updated tables on all gene therapies and cell therapies authorized and available in Europe and Italy:
