Abstract

Theoretically, cord blood (CB) banked using identical procedures by different banks should yield similar outcome if standard operating procedures (SOP) and quality programs are followed rigorously. To compare and validate the quality of the CB products, we studied whether all CB with available engraftment and/or survival transplant data from two banks, one in the USA and one in Taiwan, banked using virtually identical procedures, yielded similar transplantation outcome. Unadjusted engraftment of ANC500 were 91±3% for US (n=144) and 79±6% for Taiwan (n=49), while 1-year overall survival (OS) were 56±4% for US (n=153) vs. 68±7% for Taiwan (n=50). A number of obvious differences in transplants for the two banks were identified, for example, CB Transplants from the Taiwan CB bank (CBB) had more patients with benign diseases versus US (54% vs. 22%), which also influenced the proportion of pediatric patients and cell dose. Moreover, the Taiwan CBB had most units transplanted outside of the USA, whereas the USA CBB shipped most of its products within the USA. Another difference was that a higher proportion of CB were washed post-thaw for the USA CBB because USA transplant centers were more likely to practice post-thaw washing. We also analyzed the benign and malignant groups separately. For malignant patients, unadjusted engraftment of ANC500 were 92±3% for USA (n=114) and 73±10% for Taiwan (n=22), while 1-year OS were 50±5% for USA (n=120) vs. 40±11% for Taiwan (n=23). For benign indications, unadjusted engraftment of ANC500 were 89±6% for USA (n=30) and 85±7% for Taiwan (n=27), while 1-year OS were 66±9% for USA (n=33) vs. 92±5% for Taiwan (n=27). To adjust for some of these differences, a multivariate analysis was performed adjusting for malignancy, TNC dose, CD34+ dose, #HLA matches, recipient age, recipient sex, and washed status of CBU. Collectively, these data suggest that most of the apparent differences in outcome between the two banks may be explained by factors such as % malignant indications, and use of post-thaw wash. Overall, after adjustment for the differences between transplants using CB from the two banks, outcomes were quite similar, suggesting that if SOPs and quality programs were followed rigorously, results can be reproducible for CBB at disparate locations.

Disclosures: Lawrence Petz, Brian Wang, Tina Wu, and Robert Chow are employees of StemCyte.; Lawrence Petz, Brian Wang, Tina Wu, and Robert Chow have stock options of StemCyte.; Robert Chow is a Board Director of StemCyte.

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