The cord blood case

Umbilical cord blood (CB), long treated as waste material, is today considered a valuable source of multiple stem cells (SC) for both research and clinical applications [Waldby 2006, 1:55 ; Pelosi 2012]. CB is currently regarded as standard practice for the treatment of hematologic diseases [Samuel, Kerridge, and O’Brien 2008 ; Rao, 2011 ; McKenna 2011].

The increase in the demand for CB for clinical applications, paired with the outstanding challenges for satisfying such demand (e.g. volume and expansion, HLA diversity, etc.), has generated, in turn, a surge in the use of CB for research [Chan 2006 ; Tse 2008]. In addition to blood precursor cells, CB also contains SCs that can differentiate into other cell types fuelling speculation about the use of CB SCs for regenerative medicine [Coenen et al. 2005 ; Leor et al. 2005]. For instance, the derivation of human induced pluripotent SCs from CB cells [Giorgetti 2010] suggests the potential for a valuable and affordable source for the development of novel therapies [Lengerke 2010].

Some obstacles  have been identified to equitable access [Saginur 2004, Geransar 2009 ; FACT-JACIE 2010 ; Bordet 2010] :

  • heterogeneous scientific practices (e.g. procurement)
  • socio-ethical and policy frameworks,
  • the  coexistence of public and private networks and institutions.

 

While ethical and policy issues associated with CB collection, banking and clinical/research uses are known but not resolved [ACOG 2010; Petrini 2010;Sugarman et al. 1997; Petrini 2011; Petrini 2012; CBS 2007], there is a critical need for the development of harmonized practical tools (e.g. consent protocol and templates, donor and informational guides for oversight/regulatory bodies) and interoperable guidelines to optimize equitable access to ethically sourced CB.

This is underscored by the fact that certain ethical and policy issues arising in the research context are distinct from those arising during the process of collecting, donating and using CB for banking and clinical applications such as transplantation. Likewise, while such issues are specific to the nature of CB banking, can CB banking thrive by applying the lessons learned in biobanking generally? [Knoppers 2011] Or in the context of  paediatric biorepositories? [Hens 2011].

To answer this, EUCelLEX has proposed the examination of the current national and international CB banking landscape, compare to the biobanking models, to meet the above-mentioned challenges in both the therapeutic and research domains.