Abstract 32 Low Incidence of Product Complaints and Adverse Events Support Safety of Cord Blood Units

INTRODUCTION: As an important cellular therapy source for many patients, the safe and timely delivery of cord blood units (CBU) is paramount. The National Marrow Donor Program (NMDP) investigates product complaints received for CBUs distributed under the 10-CBA investigational new drug application that may impact the safety, quality, identity, purity, or potency of the product. NMDP also receives reports of any patient adverse events or serious complications resulting from the transplantation of CBUs. Information on product complaints and adverse events provides insight into areas related to product integrity, patient safety, and customer satisfaction and highlights opportunities for improvement. OBJECTIVE: We analyzed all product complaints and adverse events reports submitted to NMDP for CBUs distributed under the NMDP 2010 Cord Blood Access Protocol (10-CBA) from October 2019 through March 2022. These investigations offer visibility into factors associated with product quality and integrity discovered after shipment. METHODS: A total of 1,578 CBUs from 38 cord blood banks were shipped from October 2019 through March 2022 (30 months). Data on CBU product complaints reported to NMDP were compiled and analyzed. Data were grouped into categories based upon the primary reason for the product complaint or adverse event. The outcome of NMDP investigations and resolutions is relayed quarterly to the Quality Subgroup of the Cord Blood Advisory Group. RESULTS: Of the 1,578 CBUs shipped between October 2019 and March 2022, 98% had no reported incidents (32 reports of product complaints and 4 of adverse events). The most common reasons for product complaints investigated by NMDP were related to shipping/transportation (n = 15, 47%), quality issues such as lower than expected potency or bag breaks (n = 11, 34%), and labeling errors (n = 3, 9%). Three of the four adverse events were associated with infusion (two hypertensive episodes and one anaphylaxis) and one was a secondary cancer following transplant. DISCUSSION: Transplant centers report very few quality incidents, product complaints, or adverse events when using cord blood units. We remain vigilant for opportunities to improve. Clinicians and patients can be assured that CBUs are a safe product with high likelihood of arriving to the transplant center without incident or causing adverse events once transplanted.