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

Abstract

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.

Risk factors for microbial contamination of peripheral blood stem cell products

“…In our study on PBSC products, the detection of the most common bacteriologic agent (CNS) and microbial contamination rates (5.7% in the postprocessing period, 3.66% in the postthawing period) were consistent with the results of previous studies 1‐7 . In addition, patients who received contaminated PBSC products with or without antibiotic prophylaxis did not encounter any significant problems in our study, which is in agreement with previous findings from other studies 1‐3,7 …”

“…Varying rates of microbial contamination have been reported, especially with coagulase‐negative staphylococcus (CNS) after processing (0.34%‐7.2%) or thawing (0.79%‐5.4%) of stem cell products 1‐7 . Although problems were not usually experienced in transplants that are performed using contaminated products with antibiotic prophylaxis, 1‐3,7 the risk of mortality has been reported in transplants that are performed using Gram‐negative bacteria‐contaminated products 4 …”

Ten Years of External Quality Control for Cellular Therapy Products in France

“…-Considering the rare and single character of some products and the benefit/risk, the challenge is to have the best suitable test to be sure to take the decision even if a contamination has been found. -Need for a method as growth-based one to allow identification -Clinical sequelae following infusion of a microbial contaminated progenitors cells are rare (Padley et al, 2007 ;Kamble et al, 2005 ;Lowder & Whelton, 2003 ;Schwella et al, 1998 ;Klein et al, 2006) All these considerations are in agreement with those of Padley and colleagues (Padley et al, 2007) who have reviewed the product culture results and clinical outcomes from 1998 to 2006 representing 7233 haematopoietic stem cell collections. Finally, we have done a study in 2009 with the French cord blood bank to evaluate performances of automated culture system after the thawing of the cord blood units.…”

Clinical significance of positive cranial bone flap cultures and associated risk of surgical site infection after craniotomies or craniectomies

“…Stem cells are unique, life-saving products, and patients who received infusions of stem cells with positive cultures rarely had complications. 9,10,15,17,18,20,24 Accrediting agencies also accept infusions of such products given their unique nature. Following a similar line of logic, staff of the DeGowin Tissue Bank decided that a neurosurgeon could reimplant cranial flaps with positive cultures if the surgeon deemed the risk-benefit ratio favorable.…”