EOF: How patients will not fall victim to fraud “for the use of stem cells” – The recommendations

On the occasion of the allegations of misleading and deceiving patients which concern the current situation and because they refer to the recommendation for the use of stem cells, the EOF draws attention and recalls the recommendations of the European organization EMA to citizens considering the possibility of using cell therapies, which are as follows:

The European Medicines Agency warns against the use of cell therapies of unproven safety and efficacy.

The Committee of Advanced Therapies (CAT) of the European Medicines Agency (EMA) is warning patients and the general public against the use of unapproved cell therapies, as they may not be safe or effective.

CAT’s warning comes in response to the promotion by individuals, companies and hospitals of cell products of dubious safety and efficacy to treat diseases such as cancer, cardiovascular, autism, cerebral palsy, muscular dystrophy, vision loss. These products may put patients at very high risk for little or no benefit.

Patients given the dubious, unapproved cell therapies have reportedly suffered serious and sometimes fatal side effects, including infections, adverse immune reactions, tumor formation, vision loss and brain bleeding. Cell 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 in the donor, or when they are modified outside the body before being administered, 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 medicines and follow medicines legislation.

Rapidly evolving technology in the field of cell therapies is creating new, exciting prospects for treating diseases, including many that are currently incurable.

CAT points out that in order for patients to benefit from cell therapies, it is necessary to carry out well-designed clinical trials to study the safety and efficacy of the products. Such clinical trials are necessary 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 adequate information to patients about the potential benefits and risks of treatments and can be used for the approval of products in the EU, which will ultimately benefit many more patients.

During the evaluation of the data resulting from the clinical trials of cell therapies, CAT also checks whether the quality of the products is in accordance with the applicable requirements. After the approval of the Marketing Authorization in the EU, the EMA and the national medicines organizations (EOF in Greece) continuously monitor the side effects of the medicines and exchange information about their safety, so that timely decisions can be made at the European level, in order to protect the health of patients.

Applying cell therapies through routes that bypass and circumvent the Marketing Authorization and Clinical Trial Authorization procedures makes it difficult to collect, understand and document the results of cell therapies and therefore deprives future patients of access to potentially effective treatments.

CAT will continue to support the development of new cellular and other advanced therapies to continually increase patients’ timely access to proven life-changing treatments.

Patients who are considering cell therapy or their families should ask their doctor about the benefits and risks of the treatment and by what authority it has been approved. They can also contact the EOF or the EMA.

Recommendations for patients considering cell-containing therapy:

– If you are offered a treatment that uses cells, ask your doctor if it has been approved by the EOF or the European Medicines Agency (EMA).

– Ask your doctor to explain the risks and benefits of cell therapy and give you information in writing.

– Ask your doctor how you should report possible side effects of treatment

– Contact EOF or EMA if you have questions

– If you are considering treatment in a country outside the EU, check the legislation in force in that country

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