The use of Haematopoietic Stem Cells (HSCs) contained in Umbilical Cord Blood (UCB) is a well-established therapy for the treatment of patients suffering from various blood diseases.
As part of the services provided by the Italian National Health System, current legislation allows the collection and storage of HSCs that are:
- solidarity donations for allogeneic stem cell transplantation
- intended for use in a newborn with a congenital disorder or one detected prenatally, or for use in a blood relative suffering from an illness at the time of collection or from a previous illness, which is curable with UCB transplantation
- intended for families at risk of having children suffering from genetic disorders for which there is scientific evidence to support the use of UCB stem cells
- for use in autologous-dedicated clinical trials, approved in accordance with the regulations in force, aimed at gathering scientific evidence for the possible use of cord blood in the case of particular conditions
While it prohibits:
- storage for autologous use only, in the absence of the above-mentioned conditions
- the establishment of private cord blood banks across the country
- any form of advertising related to private cord blood banking
However, the collection of cord blood for personal use and its export to private facilities outside the Italian territory is allowed in compliance with the rules defined by a specific regulatory act.
On Italian territory, UCB is stored at public facilities (Umbilical Cord Blood Banks) and remains at the disposal of transplant centres that need it.
The Italian National Blood Centre, along with the Italian National Transplant Centre, works to ensure the safety and reliability of the stored UCB units to protect the health of both donors and recipients.
Alternative Uses
For several years now, the ITCBN network has been committed to developing research lines aimed at enhancing the potential of alternative applications. These areas of study include the production of red blood cell concentrates from cord blood for transfusion therapy in preterm newborns, as well as the use of plasma and platelets for the preparation of blood components for non-transfusional purposes, such as platelet gel and platelet lysate for use in eye drops.
Cord blood cells are also a versatile source of cells for advanced therapeutic applications that go beyond traditional haematopoietic transplantation. Researchers are currently exploring cord blood–derived immune cells in a range of experimental cell therapies, including the generation of chimeric antigen receptor (CAR) T cells, regulatory T cells, virus-specific T cells, and NK cells. These alternative uses, for which scientific interest is steadily increasing—also due to the proven therapeutic effectiveness of the aforementioned products—represent an important opportunity to maximise the altruistic value of donations made by mothers and couples, placing them at the forefront of regenerative and personalised medicine.
This new concept of a cord blood bank will require scientific collaboration among bank specialists, clinical researchers, and physicians specialising in other fields such as neonatology, regenerative medicine, and advanced cell therapies.