Our Safety Topics section provides information about areas of concern relating to the quality and safety of blood, tissues and organs (BTO) at a national and international level. The section will also feature topics of concern regarding clinical treatment in relation to BTO, for example, cell-based therapies.
Advice for patients considering cell-based therapies
Cell-based therapies are treatments using cells from the patient or a donor. The use of blood and cells for transplantation is a well-established medical practice. However, if cells are not used for the same essential function in the recipient as in the donor or if they are being substantially manipulated, they are not considered transplants and their safety and benefits cannot be assumed. For this reason, such therapies are regulated in the EU as medicinal products.
With new developments in cell-based therapy, it is important to be aware of unregulated and unproven cell-based therapies being offered to patients. The use of unregulated cell-based therapies may be ineffective and increase the risk of serious adverse reactions.
The HPRA is a member of the European Medicines Agency’s Committee for Advanced Therapies (CAT) and we endorse the public statement issued by CAT in 2020 warning the public against using unproven cell-based therapies.
The EMA provides useful information to patients regarding considerations to be taken if contemplating cell-based therapies. Key points from the EMA advice are contained in the graphic below.
If you have doubts about the regulated status of a cell-based therapy on offer, please contact the HPRA at firstname.lastname@example.org.