Abstract 14: Contribution of US Public Cord Blood Banking to Improved Engraftment and Survival after Allogeneic Cord Blood Transplantation (CBT)

Abstract Introduction US public cord blood banks (CBBs) produce either licensed or unlicensed HPC, Cord Blood as per FDA guidance. Accreditation and licensure status of cord blood banks using standardized banking procedures is a key parameter for selection of units for clinical transplant (I. Politikos et al., Biol Blood Marrow Transplant 26 (2020) 2190-2196). Objectives To evaluate the premise that US public cord blood banks have contributed to improvement of clinical engraftment and survival outcomes after allogeneic CBT, through delivery of high-quality cord blood units that fulfill critical CD34 and total cell dose requirements. Methods Retrospective analysis using deidentified CIBMTR outcome data-files, with investigators blinded to the identities of the donors, cord blood banks and recipients. Analysis of licensure, time in storage, cell dose, degree of HLA match, recipient age, and recipient diagnosis in three study groups, namely pre-licensure 1988-2011, (“IND pre-2012”), unlicensed and licensed units infused starting 2012 and after (“IND” and “licensed”, respectively). Statistical analyses are per Ballen et al., Biol Blood Marrow Transplant. 2020 April ; 26(4): 745–757). Results Initial analysis shows improved engraftment and overall survival for single cord CBT performed with IND and licensed units versus pre-2012 IND units. Higher TNC and CD34 doses per kg and fewer reports of contamination by TCs are seen for licensed units, which were used more frequently in single cord transplants in adults, mostly for treatment of AML with higher use of reduced intensity and non-ablative regimens. Licensed products had a higher representation of minority B/AA donors. After licensed single cord CBT, time to engraftment trended to be faster, with a 1 and 2-year overall survival benefit seen in adult recipients. Discussion 8 US cord blood banks have received license approval, contributed >50,000 licensed units to the US registry, and shipped >1,800 licensed units for transplant (NMDP registry®). FDA licensure has improved overall quality of banked CBUs translating into improvement in clinical outcomes of CBT.