Sterility testing of hematopoietic progenitor cell products: A single-institution series of culture-positive rates and successful infusion of culture-positive products

BACKGROUND: Administration of culture-positive hematopoietic progenitor cells (HPCs) causing adverse events has been a hypothesized yet largely unmeasured risk of the clinical practice of HPC transplantation. To enhance patient safety, the FDA has issued regulations prohibiting the use of culture-positive HPCs. Numerous studies have reported the infusion of culture-positive HPCs; however, the low frequency of adverse events prevents accurate determination of this risk. STUDY DESIGN AND METHODS: Product culture results and clinical outcomes from January 1998 through March 2006 representing 7233 HPC collections for 2118 transplants at a single institution were reviewed. RESULTS: A total of 119 units of HPCs (1.6%) intended for 95 patients were culture-positive. Of the 69 patients transplanted with culture-positive HPCs, 5 received products with cultures pending, and 64 received products with the positive culture results known. One of 69 patients had a new positive blood culture 5 days after infusion with the same species as the product. There was not a clinically relevant difference in the rate of infusion-related symptoms reported for patients who received culture-positive products compared to all infusions. The survival of patients who received culture-positive products (n = 69) was not different from all HPC recipients (n = 2046; p = 0.419). CONCLUSION: No infusion-related risks of culture-positive HPCs to patient safety were identified. Our data suggest that the decision to use culture-positive HPCs must be made in the context of the global risks associated with transplants such as remobilization, replacement product availability, and the nature of the organism.