Worldwide survey on key indicators for public cord bloodbanking technologies: By the World Marrow DonorAssociation Cord Blood Working Group

The Cord Blood Working Group of the World Marrow Donor Association created a survey for cord blood banks (CBBs) aimed to identify and understand the main technical procedures currently used by public CBBs worldwide regarding cord blood units (CBUs) available for unrelated hematopoietic stem cell transplantation. These technical procedures include CBU collection, (pre-) processing, packaging, testing, storage, and transport. The survey was an online survey created with SurveyGizmo and was completed individually by each CBB at the end of 2017. The information is valuable to transplant centers, CBBs as well as the global industry of public cord blood banking. In general, we can conclude from this survey that the majority of CBBs are up to standard in terms of CBB technologies. Areas of improvement include accreditation, increase standardization in testing, and setting of total nucleated cells thresholds for
acceptance of CBU for public use. Furthermore, there is a need for a consensus in the way CBBs operate in term of reservation and release to facilitate a more straightforward access to the therapy.

From the survey it emerged that Although 88% of the participating CBBs report to be licensed by a competent authority, only 50% report to have FACT accreditation and 19% have AABB accreditation. As discussed in three recent papers by Dehn et al, the Cord Blood Accociation, and Rocha, selection of CBUs from CBBs that take part in long standing voluntary accreditation programs has now been included in recommended CB selection policies as a criterion to evaluate CBUs. Based on the results of our survey, this appears to be an area where CBBs can make an effort to improve. Another recommended CB selection policy is to use RBC depleted units.5 With 97% of the responding CBBs reporting they are currently depleting units of RBC (either automatic or manually) it looks like this is now standard practice around the world. Having an attached segment for HLA confirmatory typing is also essential.5,6 Currently 95% of the responding CBBs have at least two attached segments stored with the CBU. Additionally, in the Cord Blood Association paper6 requirements for infectious disease marker (IDM) testing are given. All tests should be done on the maternal blood sample. Anti-HIV 1/2, Hepatitis C antibody, Syphilis and Hepatitis B surface antigen are required to be standard performed and 100% of CBBs report to perform these tests. Anti-CMV Total/IgG/IgM is also required to be standard performed and 96% of CBBs report to perform these. Anti-HTLV 1/2 is recommended to be standards performed and 88% of CBBs report to perform this test. Standards for CB donation do not require the need for a second testing in main transmissible diseases and in this situation it becomes critical to perform testing using NAT technologies. As shown in this survey, there is a substantial number of CBBs that performed NAT testing but still 16%-17% of the CBBs answering the questionnaire are not routinely doing this analysis. It is substandard that only 62% of the CBBs can ship a CBU in 1 week. This does not fulfill the concept that a CBU is an off-the-shelf therapy. To improve the shipping speed, it would require international harmonization between CBBs. Furthermore, there is not a good consensus in when/how to do the release testing on an attached segment. This also generates a non standardized result between CBBs. This is a field where the CBBs need to work together to facilitate access to the therapy. Only 42% of CBBs answered they use a threshold of TNC >100x10E7 for accepting a CBU for public use. The standards only have instructions on how much TNC a CBU must contain at the end of the process and only mention a CBB must have a policy in place to verify it. From the survey results, it cannot be identified why a CBB would bank CBU with low TNC counts knowing these are less likely to be requested. In recent years it has become harder to sustain a successful CBB and CBBs perhaps should consider only bank larger units because they are most on demand. The questions about testing thresholds for accepting a CBU for public use (postprocessing) were answered in a wide range with many CBBs answering not applicable or leaving the answer blank. Therefore, this part of the questionnaire is inconclusive and difficult to interpret. This could either be due to the fact that the questions were unclear and difficult to fill out, or the fact that there is no consensus in the CBB field on thresholds for these tests. Moreover, the FACT standards are not specific about the time point in the CBB process pre-evaluation of the CBU should take place. However, the information gained from these questions about practices of pre-evaluation is still relevant for CBBs to know about. It matters to the CBBs in terms of benchmarking, self-evaluation and how a CBB defines which units are “bankable.” A response rate of 59% is considered high for these types of surveys, which indicates the commitment of the CBB community to make this information available to TCs and other CBBs. One thing to keep in mind is that these results were current at the end of 2017/ beginning of 2018. As the CBB field is fast moving, these data shoulD be closely monitored. Future directions of collecting this kind of data needs to be aligned with the Netcord-FACT standards seventh edition. WMDA will collect a summarized version of this survey in 2020, where CBBs can directly submit their data to the WMDA Share website.

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