Stem Cells, Clearly Understanding stem cells
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Stay safe

I've been offered a stem cell treatment: how to tell if it's legitimate.

Stem cell therapies that are actually approved are few, and they are for specific diseases. Meanwhile, in Italy and abroad, unproven treatments are being sold, often expensive and not without risks. This page helps you recognize them and ask for help.

Who it's forPatients, families, curious readers
SourcesFDA, EMA, AIFA, ISSCR, published studies
LimitationDoes not replace your doctor's advice

In brief

  • Be wary of anyone who promises cures, treats many different diseases with the same cells, or shows testimonials instead of published studies.
  • “They're your own cells, so it's safe” is not true: a patient's own cells, prepared and injected outside the rules, have even caused blindness, and the FDA reports serious infections and tumors after unauthorized treatments.
  • Being listed in a clinical trial registry does not mean being approved or safe.
  • Before deciding, talk it over with your doctor or with a specialist center of the Italian National Health Service. Suspicious offers can be reported.

Red flags

When an offer should make you suspicious

  • The same treatment for many different diseases. Stem cells in adult tissues produce only the cell types of their own tissue: it is very unlikely that the same treatment works for different diseases. The ISSCR urges extreme caution toward clinics that offer the same treatment for many conditions. Source: ISSCR.
  • Testimonials instead of data. Patients' stories can be misleading: an improvement may be due to the placebo effect, to other treatments or to the natural course of the disease. Source: ISSCR.
  • An “experimental” treatment that you pay for. An experimental therapy offered for sale is not a clinical trial: real trials have ethical and regulatory oversight and a structured design, and the cost of the treatment and of the check-ups is not borne by the participant. Source: ISSCR.
  • “They're your own cells, there are no risks.” A patient's own cells can be contaminated, altered during processing or injected in the wrong place. Source: ISSCR.
  • Promises of safety and effectiveness without authorization. The FDA warns that these products are often illegally marketed as safe and effective, without adequate studies. Sources: FDA, EMA.
  • Haste, package deals, trips abroad. Pressure to decide right away, discounts, one-day treatments at a distant clinic with no plan for follow-up checks are warning signs that should not be underestimated.

Questions to ask

Before accepting any treatment

1

Is it authorized?

For which disease is it authorized, and by whom (AIFA, the Italian Medicines Agency, or EMA)? If it is not, is it a clinical trial approved by an ethics committee?

2

What evidence is there?

Which published studies show that it works for my disease? With how many patients, compared with whom?

3

What are you injecting into me?

Which cells, where do they come from, how are they prepared and checked? In which authorized facility?

4

What are the risks, and who will look after me?

What side effects are possible, and who will look after me in the following months if something goes wrong?

5

How much does it cost, and why?

What exactly am I paying for? Why should I pay for a treatment presented as experimental?

6

Can I consult another doctor?

Anyone offering a legitimate treatment has no problem with you discussing it with your doctor or with a specialist at a public center.

Questions based on guidance from the ISSCR and the FDA.

Clinical trials

How to check a clinical trial

Ask for the trial code

A legitimate trial is registered in a public registry and has a code: for example “NCT” followed by eight digits on ClinicalTrials.gov, or the European code on the CTIS portal, which has collected EU trials since January 31, 2022.

Registered does not mean approved

A trial being listed in a registry does not mean that the treatment is authorized or safe: the FDA says so explicitly for ClinicalTrials.gov. Source: FDA.

Look at the phase

Phase 1 mainly assesses safety in a small number of people; phase 2 begins to measure the effect on the disease; phase 3 compares the treatment with a placebo or with existing treatments in hundreds or thousands of patients. Source: AIFA.

Documented harm

Why it is not a “risk-free” choice

What the FDA reports

Reported adverse events include blindness, tumor formation, neurological events, and bacterial infections, including serious blood infections. In 2019 a federal court ruled in favor of the FDA against a clinic that was selling a product made from patients' fat. Sources: FDA, FDA, June 4, 2019.

The rules in Italy

The only three legal routes

Therapies with manipulated cells, including stem cells, are medicines in every respect: in the European Union they are called advanced therapy medicinal products and are governed by Regulation (EC) 1394/2007. According to AIFA, they can be used legally only in one of these three cases.

1. A medicine authorized by EMA

Authorization must go through the centralized European procedure. In Italy, approved advanced therapies are paid for by the National Health Service. Sources: AIFA, advanced therapies, 2026 AIFA guide.

2. An authorized clinical trial

For the patient, taking part is completely free. Trials authorized in Europe can be checked on the CTIS portal. Source: 2026 AIFA guide.

3. Hospital exemption

A special AIFA authorization for a single patient, only in a public hospital, a university clinic or an IRCCS (an Italian research hospital), when there is no valid alternative and there is a danger to life or of serious harm to health; the opinion of an ethics committee is also required. Source: AIFA, non-routine use of advanced therapies.

An Italian lesson

The Stamina case, in brief

  • 2011–2012. Between October 2011 and April 2012, at the Spedali Civili di Brescia hospital, 12 patients (4 children and 8 adults) received cells prepared with the so-called Stamina method, in collaboration with Stamina Foundation. After inspections by the Carabinieri health protection unit (NAS) and AIFA, on May 15, 2012 an AIFA order banned the collection, manipulation and administration of those cells. Sources: Italian Senate, final document of the inquiry (2015), AIFA, May 16, 2012.
  • 2013. The decreto-legge 25 marzo 2013, n. 24 (Decree-Law No. 24 of March 25, 2013) allowed treatments already begun in public facilities to continue and provided for a trial coordinated by the Istituto Superiore di Sanità (Italy's National Institute of Health), with funding of up to €3 million. Source: Normattiva.
  • 2013–2014. Two scientific committees appointed by the Ministero della Salute (Italy's Ministry of Health) unanimously concluded, in September 2013 and in October 2014, that there was no basis for a trial. In 2013 the minister justified the halt by citing the “inadequate description of the method,” the “insufficient definition of the product” and the “potential risks for patients.” Sources: Senate, Science, 2014.
  • 2015. On February 18, 2015 the Senate's Commissione Igiene e Sanità (Hygiene and Health Committee) unanimously approved the final report of its fact-finding inquiry into the case. In Turin, according to the press, the president of the foundation and a doctor involved plea-bargained suspended sentences, on condition that they cease the activity, in proceedings that included the charge of criminal conspiracy to commit fraud. Sources: Senate, 2015, Il Fatto Quotidiano, March 18, 2015.

As early as 2013, the journal Nature wrote that there was no evidence that the treatment worked and that it could be harmful (Nature, December 13, 2013). The case shows how easy it is, faced with the suffering of patients, to mistake a promise for a cure: that is why scientific evidence and checks by the authorities are a safeguard, not an obstacle.

Getting help

Who to turn to and where to report

Your doctor and public centers

Before any decision, AIFA recommends a second opinion from qualified specialist doctors and talking with patient associations for your disease. Source: 2026 AIFA guide.

Carabinieri health protection unit (NAS)

They also act on complaints or reports from the public and deal with, among other things, health advertising, doctors' offices and outpatient clinics, and the unauthorized practice of health professions. Source: Ministero della Salute, NAS.

Medical Council (Ordine dei Medici)

If the treatment is being offered by a doctor, disciplinary power lies with the provincial Medical Council where that doctor is registered. Source: Codice di deontologia medica.

Misleading advertising

Websites, social media and ads that promise miracle cures can be reported free of charge to the Autorità garante della concorrenza e del mercato (AGCM, the Italian Competition Authority). Source: AGCM, online reporting.

Sources

References used on this page

Page checked on October 2, 2026.