On the occasion of her A recent case of patient fraud by a fake doctor allegedly using stem cell therapy, the National Agency for Medicines (EOF) draws attention and recalls the recommendations of the European organization EMA to citizens considering the use of cell therapy.

In particular, the Committee on Advanced Therapies (CAT) of the European Medicines Agency (EMA) has warned against using cell therapies with unproven safety and efficacy.

CAT’s warning came in response to individuals, companies and hospitals promoting cellular products of questionable safety and efficacy in the treatment of diseases such as cancer, cardiovascular disease, autism, cerebral palsy, muscular dystrophy, and vision loss. These products may put patients at very high risk with little or no benefit.

Patients treated with questionable, unapproved cell therapy suffered serious and sometimes fatal side effects, including infections, adverse immune responses, tumor formation, vision loss, and cerebral hemorrhage.

Cellular therapies are products that use cells from the patient themselves or from another donor. The use of blood and cells for transplantation is a well-established medical practice.

But when the cells are not used in the patient for the same function as the donor, or when they are modified outside the body before administration, then they are not considered transplants, so the safety and benefits of their use cannot be taken for granted. For this reason, such treatments in the EU are classified as drugs and are regulated by the drug law.

Clinical Trials Needed

CAT notes that in order for patients to benefit from cell therapy, well-designed clinical trials are needed to study the safety and efficacy of the products. Such clinical trials are essential not only to understand the safety and efficacy of treatments, but also to protect the safety, dignity and rights of patients. In addition, well-designed clinical trials provide patients with adequate information about the potential benefits and risks of treatment and can be used to approve products in the EU, ultimately benefiting many more patients.

When evaluating data from cell therapy clinical trials, CAT also checks that product quality meets applicable requirements. Once the marketing authorization is approved in the EU, the EMA and the National Medicines Organizations (EOF in Greece) continuously monitor the side effects of medicines and share information about their safety so that timely decisions can be made at the European level. to protect the health of patients.

The use of cell therapy in ways that bypass and circumvent marketing authorization and clinical trial authorization procedures makes it difficult to collect, understand, and document the results of cell therapy, and therefore deprive future patients of access to potentially effective therapies.

Patients who are considering cell therapy, or their family members, should ask their doctor about the benefits and risks of the treatment, as well as which authority it has been approved by. They can also contact EOF or EMA.

Recommendations for Patients Considering Cell Therapy

• If cell therapy is recommended for you, ask your doctor if it is approved by the EOF or the European Medicines Agency (EMA).
• Ask your doctor to explain the risks and benefits of cell therapy and provide you with the information in writing.
• Ask your doctor how you should report possible side effects of treatment.
• Contact EOF or EMA* if you have any questions
• If you are considering treatment in a country outside the EU, check the current legislation of that country.