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.