Work

Immediate Adverse Events Following infusion of ex vivo-Expanded Cord Blood for Stem Cell Transplantation

Year: 2011

Type: article

Abstract: Umbilical cord blood (CB) is utilized with increasing frequency to restore hematopoiesis in bone marrow transplant patients lacking a suitable HLA-matched donor. CB transplantation (CBT) is limited by low cell doses and delays in neutrophil and platelet engraftment. CB progenitors expanded ex vivo prior to transplantation provide more rapid hematopoietic and immune reconstitution, as well as less engraftment failure compared to unmanipulated CB. However, the relative safety regarding the infusion of ex vivo-expanded CB has not been systematically examined. Here we review the immediate adverse events (AE) associated with infusion of ex vivo-expanded CB occurring within 24 hours of infusion in 92 patients enrolled in two clinical CB expansion trials at the MD Anderson Cancer Center from February 2004 to May 2010. The median age of enrolled patients was 42 years (range 3-66), with a predominance of males (n = 60). 47 patients received a CBT for treatment of acute leukemia. 24 patients had a previous stem cell transplant (22 autologous and 2 allogeneic). The majority of patients (n = 80) were pre-medicated prior to transplantation with a combination of diphenhydramine and steroids. All patients received an unmanipulated CB unit followed by infusion of the ex vivo-expanded CB product after 1 hour. ABO mismatching was observed in 28/89 and 22/89 unmanipulated and ex vivo-expanded CB products, respectively. The mean volume of the infusions was 109 mls (range 45-249 mls) for the unmanipulated CB units and 134 mls (range 39-180 mls) for the expanded product. A total of two Grade 1-2 and five Grade 3-4 infusion reactions occurring within 24 hours after CBT of both products were observed. This resulted in an AE rate of 8%. The majority of the AEs manifested as signs of dyspnea and hypoxia and could be attributed to either vasovagal reactions or volume overload. However, no association with patient age, disease, previous transplant, total infusion volume, or ABO incompatibility was observed. In summary, infusion related toxicities in patients who receive an unmanipulated and ex vivo-expanded double CBT appears relatively low. We conclude that infusion of unmanipulated followed by expanded CB products is a safe procedure associated with a low probability of inducing severe reactions. We are currently examining the incidence of infusion related toxicities in patients who have received only unmanipulated CB products.

Source: Transplantation and Cellular Therapy

DOI: 10.1016/j.bbmt.2010.12.472