Public banking of umbilical cord blood or storage in a private bank: testing social and ethical policy in northeastern Italy

Abstract

Background: In northeastern Italy, according to Italian legislation, authorized public facilities can accept the donation and preservation of cord blood stem cells (CB-SC). Attitudes and knowledge in pregnant women differs between the local and immigrant (non-European Union [EU]) population. In this study we assessed the choices that pregnant women have with respect to the public and private harvesting system and the main reasons driving their decisions. We examined the ethnic origin of the families and compared tests for syphilis screening and leukocyte (WBC) counts in the CB-SC bags that are required for validation of the collection.

Methods: Out of a population of 3450 pregnant patients at the Institute for Maternal and Child Health of Trieste, northeast Italy, 772 women agreed to cord blood harvesting and the associated lab tests. Of these, 221 women (28.6%) were from immigrant families of non-EU countries. Their ethnic affiliation was recorded, and tests were performed for syphilis screening and for nucleated red blood cell (NRBC) interference with the WBC count in CB-SC bags to assess cellularity and to determine if storage was appropriate.

Results: Of the 772 pregnant women, 648 (84.0%) accessed the public collection system, which is free of charge, and 124 (15.0%) accessed the private fee-based system. One woman from the non-EU group opted for the private fee-based system. Of the 3450 pregnant women screened for syphilis at the Institute for Maternal and Child Health, the Treponema pallidum hemagglutination (TPHA) and Venereal Disease Research Laboratory (VDRL) tests were the main tests performed (66.0% of total cases) because many gynecologists in the public harvesting system apply the Italian regulations of the 1988 Decree, while the private system requires tests on syphilis and leaves the option to the lab physicians to select the best determination method. We found that the chemiluminescence method was more specific (97.0%) than the TPHA (83.0%) and nontreponemal rapid plasma reagin VDRL (75.0%) tests (P < 0.05, χ(2) test). The specificity link between the two automatic methods versus microscopes for WBC dosing and NRBC interference was r(2) = 0.08 (ADVIA 120) and r(2) = 0.94 (XE-2100). The public system does not include human T-cell lymphotropic virus testing; this is reserved for the population from endemic zones.

Conclusion: In northeastern Italy current legislation prevents the establishment of private fee-based banks for storage of CB-SC. The cryopreservation, for future autologous personal or family use, is possible only by sending to foreign private banks, with a further fee of €300. These regulations confirm that Italian legislation tries to increase the anonymous allogenic donations and the number of CB-CS bags stored in the free-cost public system, that are available to anyone with therapeutic needs. Private banking is used almost exclusively by the wealthier local population. In the public system, many physicians continue to use older Italian laws regarding syphilis diagnosis, and NRBC interference on WBC count may have an impact on cord blood harvesting. Our findings suggest that in the EU there is no consensus policy on donor management. The value of storage for potential use within the family is useful only with collaboration between the public and the private systems.

Keywords: cord blood collection; pregnant women’s choice; private system; public system.

Figure 1

Main reasons for choosing private system on 124 cases: 52.4% non hematological diseases, 24.1% highest degree of safety test, 13.7% non collection in festive or pre-festive days, 8.0% technical problems in previous experience, 1.6% other.

Figure 2

Metabolic pathologies of 65 cases. Notes: 50% diabetes, 19% celiac disease, 18% cystic fibrosis, 8% cardiovascular disease, 5% degenerative diseases, such as Alzheimer’s disease.

Figure 3

White blood cell dosing and nucleated red blood cell interference: specificity between two automatic analyzers and microscope count. Note: Y and X axes: units of measurement: 10³ μL. Abbreviation: NRBC, nucleated red blood cell.