From donor to patient
“Public Banking”, or public donation, means putting your baby’s umbilical cord cell sample at the disposal of those who might need it and is available to mothers who intend to give birth in a hospital in partnership with an Italian public biobank (there are 19 in Italy).
Public banking is regulated by Legislative Decree 191 of 6 November 2007 – G.U. N.261 9/11/2007, implementing European Directive 23/2004, defining a tissue bank as a “unit of a public hospital or a sector of a transfusion service, as set forth by legislative decree 191 of 19 August 2005, or a non-profit healthcare unit, in which activities of processing, preservation, storage or distribution of human tissues and cells are undertaken, or an authorized health centre. Obviously, the same definition and regulations apply in European countries with national registers that have to respect WMDA standards (link to WMDA).
Public banking of cord cells started up in 1991 when the first bank was opened in the New-York Blood Center. Today there are over 100 public cord stem cell banks containing over 500,000 samples. The majority of public banks cooperate through international registers in which they announce the results of compatibility tests (high or low resolution HLA typing) of cord blood, bone marrow and peripheral blood after haemapheresis.
The main international bodies are:
- WMDA – World Marrow Donor Association
- BMDW – Bone Marrow Donors Worldwide
- NMDP – National Marrow Donor Program
- Netcord Foundation (Fact-Netcord accreditation)
These bodies also guarantee the respect of high quality standards for the storage and therapeutic use of samples. Eurocord is the organization uniting researchers and biologist studying stem cells from the umbilical cord or from the placenta, to promote scientific research at both academic and industrial level.
The Italian public system, aided by the Centro Nazionale Sangue (CNS) and Centro Nazionale Trapianti (CNT), has a national network of 19 blood banks, currently operative in 13 different regions: the latest to be established is the Bank of Sardegna in Cagliari.
Donation has to take place in hospitals in partnership with a public biobank with high selection guidelines to guarantee “maximum safety” if the sample is used by other people, since it becomes anonymous when entered in the international donation registers.
To be able to donate the mother has to:
- sign a form giving her informed consent
- undergo – before and after birth – some infectivology tests
- have recently had her water break (less than 12 hours)
- not had fever or taken medications during pregnancy
- in addition, least 60 ml. of blood must be collected
Unfortunately, practical impediments can occur since on holidays or weekends many facilities do not guarantee the transfer of the sample to the public biobank in the necessary time. Because of this and because of all those mothers who give birth in units not linked to a public bank and thus without the possibility of donating their cord blood, the relationship between units collected and units banked (or “banking index”) in the public banks of the Italian network (ITCBN – Italian Cord Blood Network) is around 25-27%. This means that out of 100 units collected only 25-27 are suitable for preservation and thus for clinical use (one of the reasons for exclusion is also the number of cells present in the unit; no limit has been established for “dedicated” units so that all the samples collected with this purpose are cryopreserved). Considering that the annual average of births in Italy is around 500,000, hospitals currently throw away some 95% of cord samples.
To support public banks, there is a cost for collecting and using samples worldwide fixed by international agreements of some €17,000 per sample, plus testing and transport costs. In Italy this cost is supported by the taxpayer and therefore there are no extra expenses if a sample is needed.
As of 31 March 2011, there were 33,091 cord blood units banked, of which 71% entered in the IBMDR (Italian Bone Marrow Donor Registry). 36.6% of these are typed for high-resolution HLS antigens.
The decree of 18/11/2009 – G.U. N.303 31/12/2009 enables some parents to carry out “dedicated autologous preservation” or “the preservation of stem cells from umbilical cord blood for autologous use dedicated to the same baby or to a blood relations suffering from a disease at the time of the collection, for which the use of stem cells from cord blood is scientifically based and clinically appropriate, after presentation of motivated clinical documentation”.
The pathologies for which the Ministry of Health specifies the “dedicated” collection of cord blood are listed in the table “THERAPEUTIC USE”
Use
Public banking is useful when stem cells are needed by someone other than the donor. This is the “allogeneic or heterologous” transplant, whether intra- or extra-familial.
There are many pathologies in which children have frequently to undergo allogeneic stem cell transplants, including genetic diseases such as thalassemia, requiring only and exclusively donor cells. In these cases, the patient’s stem cells are unable to recognise the diseased cells or can even actually contain them, provoking the reappearance of the disease. Hence the use of allogeneic transplants.
The probability that two non-blood relations are histocompatible is very low, ranging from 1/50,000 to 1/100,000 according to race, even if the probability of retrieving a sample from international registers is between 50% and 80% for Caucasians. At world level, over 1/3 of transplantations occur between siblings.
(Source: Haematologica, July 2011).
From 1995 to March 2011, 1057 samples have been used but only 30% of them for Italian patients.
Despite the 3.9 cord units per 10,000 inhabitants currently available in Italy, the public health system intends to adopt strategies to guarantee a national “self-sufficiency”, increasing both the number of samples banked and improving the times for making them available for national transplant centres.
