Twenty years of unrestricted hematopoietic stem cell collection and storage: impact of Joint Accreditation Committee International Society for Cellular Therapy Europe standards implementation on stem cell storage policy and resource utilization

Autologous peripheral blood stem cells transplantation (aPBSCT) is a therapeutic option that can be used in various hematological neoplastic disorders; it implies the infusion of previously collected and cryopreserved stem cells (CSC). Collected CSC are not always infused for a variety of reasons, including death before aPBSCT, lost to follow-up, no further clinical need or collection exceeding requested cell dose. The former case entails the elimination of CSC bags, whereas other cases generate ethical, medical and legal issues because it is essential to document that the conditions for disposal have been met and are not in contradiction with consent forms signed at the time of collection. PBSC collection began more than 20 years ago at our institution, and, in 2008, we began a quality management program according to Joint Accreditation Committee International Society for Cellular Therapy Europe (JACIE [ISCT]) standards. JACIE is a quality management system designed to improve quality of care by the use of well-defined standards, rules and inspections 1, 2 and 3. We now retrospectively report results of uncontrolled CSC storage policy from 1990–2008 and after 3 years of JACIE standards implementation. By analyzing medical records, we collected data on clinical indications, number of leukaphereses, number of collected and infused bags per patient, number of unused CSC bags per patient and resource allocation. Statistical analysis was performed with the use of “GraphPad Prism” (GraphPad Software Inc., San Diego, CA, USA). The χ2 test was chosen for the analysis of the categorical factors. Statistical significance was defined as P < 0.05.