Audit of donor centre: guidelines by the World Marrow Donor Association Quality and Regulation Working Group

According to the Standards of the World Marrow Donor Association (WMDA) 2020 [1] unrelated stem cell donor registries are responsible for compliance of their donor centres with these Standards. To ensure high stem cell product quality and high standards for safety and satisfaction of voluntary unrelated stem cell donors, we present here guidelines for audits of donor centres (DC) that can be used by new and established donor registries. They have been developed for registries relying on independent national or international DCs for the recruitment and management of Unrelated Donors (UD) for verification typing (VT)/extended tying (ET), work up processes and Hemopoietic Progenitor Cell (HPC) donation. The main goal of these guidelines is to support registries in verifying and auditing their affiliated DCs to ensure they are compliant with the WMDA Standards, as well as WMDA recommendations. We define the general requirements and recommendations for collaboration with the DC and guidelines to manage the UD, step by step from recruitment to follow-up. We also provide a checklist, intended to serve as a resource for auditors performing an audit at a DC.

Introducing a Platform for Integrating and Sharing Stem Cell Research Data

Advancements in regenerative medicine have highlighted the need for increased standardization and sharing of stem cell products to help drive these innovative interventions toward public availability and to increase collaboration in the scientific community. Although numerous attempts and numerous databases have been made to store this data, there is still a lack of a platform that incorporates heterogeneous stem cell information into a harmonized project-based framework. The aim of the platform described in this study, ReMeDy, is to provide an intelligent informatics solution which integrates diverse stem cell product characteristics with study subject and omics information. In the resulting platform, heterogeneous data is validated using predefined ontologies and stored in a relational database. In this initial feasibility study, testing of the ReMeDy functionality was performed using published, publically-available induced pluripotent stem cell projects conducted in in vitro, preclinical and intervention evaluations. It demonstrated the robustness of ReMeDy for storing diverse iPSC data, by seamlessly harmonizing diverse common data elements, and the potential utility of this platform for driving knowledge generation from the aggregation of this shared data. Next steps include increasing the number of curated projects by developing a crowdsourcing framework for data upload and an automated pipeline for metadata abstraction. The database is publically accessible at https://remedy.mssm.edu/.

Cluster of Infections Associated With Contaminated Stem-Cell Products

Background: The unapproved and unregulated use of umbilical stem-cell products has been identified as a possible source of adverse events and infection. In 2018, a national outbreak of multiple bacterial infections was associated with use of umbilical stem cells products. From December 2018 through March 2019, the Los Angeles County Department of Public Health (LACDPH) identified 4 cases of bacterial infection in patients that had received therapies using umbilical stem-cell products. Although 2 cases were associated with the national outbreak of a single company’s product, 2 additional cases of Enterobacter cloacae were instead associated with a second stem-cell distributer. Methods: In December 2018, LACDPH staff received notification from a hospital infectious disease physician of 2 cases of E. cloacae infection in patients of a freestanding ambulatory surgery center following allogenic umbilical cord stem-cell injections on the same day in August 2018. LACDPH reviewed the medical records of these patients and conducted an on-site visit to the ambulatory surgery center, which included observation of infection prevention practices, interview of staff, and review of logs. The 2 isolates from each patient were sent to the CDC laboratory for relatedness testing. Results: The 2 case patients received products via intra-articular injection from different lot and donor numbers for lumbar spine pain. In addition to the stem-cell product, both patients also received antibiotics and pain medications during their procedures, though from different vials. Both patients were seen by the same surgeon, anesthesiologist, and nurse during their procedures. No additional cases occurred. The case patients were hospitalized for 12 and 27 days, respectively. Whole-genome sequencing indicated that the isolates from the 2 patients were related. No major gaps in infection prevention practices were identified at the surgery center. Conclusion: This report describes a cluster of 2 E. cloacae infections in patients who had received unapproved-use stem-cell products via spinal injection. Given molecular laboratory results and infection prevention observations, we hypothesize that the stem-cell products used on these 2 cases were likely contaminated before distribution. This cluster demonstrates that contamination of stem-cell products extends beyond the single outbreak previously described and points to the systematic inability to ensure the safety of unapproved use of umbilical stem- cell products.Funding: NoneDisclosures: None