Abstract 10 Experience with Enrollments and Releases Within a Medical Needs Program at a Large U.S. Private Cord Blood Bank

INTRODUCTION: Medical Needs / Directed Donor programs provide families with access to cord blood for potential future use. In situations where a diagnosis, potentially treatable with cord blood, exists in an immediate relative of the newborn, these programs often allow families to preserve newborn stem cells at little to no cost. OBJECTIVES: The objective of this study was to examine indications for enrollment and unit releases in a medical needs program at a large U.S. private newborn stem cell bank. METHODS: Enrollment data over a 24-year period was analyzed. Data was categorized by indications for enrollment and indications for which units were released. RESULTS: There was a total of 7,034 enrollments within the specified timeframe. Most enrollments were for indications treatable by hematopoietic stem cell transplant given the program did not include experimental indications until 2019. Approximately one-third of enrollments (33.4%) for transplant indications were for various types of leukemia. The experimental indications most frequently represented in enrollments were autism (44.3%) and cerebral palsy (38.4%). For all cord blood units stored under the medical needs program, the majority (70%) of releases were intended for use in transplant medicine. The most frequently represented transplant indication for releases was hemoglobinopathies including sickle cell anemia and beta thalassemia (44.6%). Approximately one-third (36.1%) of transplant releases were related to leukemia. Autism and cerebral palsy were the two most frequently represented experimental indications for units released at 39% and 36%, respectively. DISCUSSION: Clinical indications were mostly consistent between enrollments and releases through this cohort. This suggests the structure of the program is effective in identifying families who have a higher likelihood of utilizing their cord blood unit for a transplant or experimental infusion. Cord blood banks should continue to re-evaluate the eligibility criteria for their medical needs programs in light of relevant updates in the potential utility of newborn stem cells including changes in transplant medicine indications and treatment procedures, as well as clinical trials and experimental protocols using related cord blood units. Future research related to pathways of referral to medical needs programs may inform education gaps among women’s health providers.