Exploring “quality” in cord blood transfusion: uncertainties, bionetworks, and collaborations

Figures & data

Figure 1. Cord Blood Treatment Process. The Cord Blood Treatment Process that was developed following interviews. A number of factors that contribute to the “systems” uncertainty have been noted for each phase of the process.

Table 1. Examples of uncertainties surrounding key “quality” markers for CBU based on published literature.

CD34 + count	CD34 + count has been criticized as a poor marker of stem cell presence as many CD34 + cells do not play a role in engraftment (Rich 2015)
CD34 + count and HLA match	Higher CD34 + count and closer HLA-match have been shown to correlate with improved survival (Wagner et al. 2002; Eapen et al. 2011)
CD34 + and viability	CD34 + viability is more closely associated with successful engraftment than CD34 + count (Scaradavou et al. 2010). There is high variability between laboratories calculating CD34 + count and measuring cell viability, including CD34 + viability, “remain(s) difficult” (Hough et al. 2016)
TNC count and CD34 + count	TNC count can be used as a surrogate for CD34 + count and is comparatively easy for laboratories to measure. A retrospective evaluation has shown no clinical differences when using TNC count alone, rather than together with CD34 + count, in CBU selection (Jaime-Pérez et al. 2011). This only shows that TNC count can provide good clinical outcomes, not that it is a good marker of CBU “quality” High TNC and CD34 + counts do not measure stem cell potency (i.e. dose required for successful engraftment), which has been argued to be a more accurate measure of “quality”
TNC counts and potency assays	To improve understanding of CBU “quality,” some suggest that banks should be performing potency assays to know a CBU’s biological activity and testing the thawed unit rather than the pre-frozen one (Rich 2015). By using TNC counts that achieve good clinical outcomes, UK guidelines display an inclusive, pragmatic definition of CBU “quality” rather than stringently relying on potency (Hough et al. 2016)

Table 2. A comparison of UK and Japanese consultants’ decision-making when contemplating “quality” cord blood units.

UK Consultants	Japanese Consultants
Trust formed through local collaboration	Trust in individuals in performing key tasks
Trust created through knowledge of others in the process and system	Trust created through past experiences of working with individuals in the process and system
Trust in organizations and in teams	Trust on a one-to-one basis and direct experience with individuals
Trust working within international policies	Trust generated by setting more pre-requisites to determine “quality”
Country reliant on international network	Country self-reliant

Rich, I. 2015. “Improving Quality and Potency Testing for Umbilical Cord Blood: A New Perspective.” Stem Cells Translational Medicine 4 (9): 967–973. doi:10.5966/sctm.2015-0036.

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Wagner, A., J. N. Barker, T. E. DeFor, K. S. Baker, B. R. Blazar, C. Eide, A. Goldman, et al. 2002. “Transplantation of Unrelated Donor Umbilical Cord Blood in 102 Patients with Malignant and Non-Malignant Diseases: Influence of CD34 Cell Dose and HLA Disparity on Treatment-Related Mortality and Survival.” Blood 100 (5): 1611–1618. doi:10.1182/blood-2002-01-0294.

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Eapen, M., J. P. Klein, G. F. Sanz, S. Spellman, A. Ruggeri, C. Anasetti, M. Brown, et al. 2011. “Effect of Donor-Recipient HLA Matching at HLA A, B, C, and DRB1 on Outcomes After Umbilical-Cord Blood Transplantation for Leukaemia and Myelodysplastic Syndrome: A Retrospective Analysis.” The Lancet Oncology 12 (13): 1214–1221. doi:10.1016/S1470-2045(11)70260-1.

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Scaradavou, A., K. M. Smith, R. Hawke, A. Schaible, M. Abboud, N. A. Kernan, J. W. Young, and J. N. Barker. 2010. “Cord Blood Units with Low CD34+ Cell Viability Have a Low Probability of Engraftment After Double Unit Transplantation.” Biology of Bone Marrow Transplantation 16 (4): 500–508. doi:10.1016/j.bbmt.2009.11.013.

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Hough, R., R. Danby, N. Russell, D. Marks, P. Veys, B. Shaw, R. Wynn, et al. 2016. “Recommendations for a Standard UK Approach to Incorporating Umbilical Cord Blood Into Clinical Transplantation Practice: An Update on Cord Blood Unit Selection, Donor Selection Algorithms and Conditioning Protocols.” British Journal of Haematology 172 (3): 360–370. doi:10.1111/bjh.13802.

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Jaime-Pérez, J., R. Monreal-Robles, L. N. Rodríguez-Romo, C. Mancías-Guerra, J. L. Herrera-Garza, and D. Gómez-Almaguer. 2011. “Evaluation of Volume and Total Nucleated Cell Count as Cord Blood Selection Parameters: A Receiver Operating Characteristic Curve Modeling Approach.” American Journal of Clinical Pathology 136 (5): 721–726. doi:10.1309/AJCPFB6EXO7BJVLR.

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