Adverse Events after Infusions of Cryopreserved Hematopoietic Stem Cells Depend on Non-Mononuclear Cell in Infused Suspension and on Patient Age.

We have prospectively collected data on Adverse Events (AE) that occurred in 179 Hemopoietic Progenitor Cell (HPC) infusions performed in patients affected with haematological neoplasm, after high dose chemotherapy. Stem cell source was Hemopoietic Progenitor Cells Aphaeresis (HPC-A) in 157 cases and Hemopoietic Progenitor Cells Bone Marrow (HPC-BM) in 22 cases. In all cases, an endotoxin-free DMSO was used. One or more AE were registered in 51/179 infusions (28.6%). Frequency of AE was higher after HPC-A than after HPC-BM (31.3% versus 4.5%, (chi square test: p=0.008). In univariate logistic regression other factors found important for AE were: Age (p=0.028), Number of Total Nucleated Cells infused/kg (P=0.002), Volume/kg infused (p=0.057), Volume of Packed Red Blood Cells (p=0.019), a content of Non-Mononuclear Cells >0.500 × 10⁸/Kg (<p=0.0001) and Actual Time of infusion (p=0.058). When all aforementioned factors were evaluated in multivariate logistic regression only Age of patient (P=0.024) and a content of Non-Mononuclear Cells > 0.5×10⁸/kg (P=0.0003) remained significant. No cardiovascular events were recorded during infusions. A significant correlation existed between reduction of cardiac frequency both with Volume/Kg infused (r 0.221; p=0.02) and with Actual Time of infusion (r 0.269; p=0.005). In conclusion, while Cardiovascular Changes are influenced by Volume/Kg infused and by Actual Time of infusion, Non-Cardiovascular AE are dependent on patient Age and on contamination by Non-Mononuclear Cells in apheretic harvests.