Performance prediction algorithm for autologous PBSC collection in adults and pediatric patients using large volume leukapheresis

Abstract

Background and Objectives The number of CD34+ cells collected in apheresis procedures depends mainly on the collection efficiency of the device and the blood volume processed. Large volume leukapheresis (LVL) can improve CD34+ cell yield and has previously been investigated using the COBE Spectra device (Terumo BCT, USA). Materials and Methods This was a retrospective analysis of LVL performance in patients undergoing continuous mononuclear cell collection (CMNC) using the new Spectra Optia apheresis system (Terumo BCT, USA) at the University Hospital Center, Zagreb, from March 2016 to September 2016. CD34+ cell yield predictability, determined using a customized algorithm, was also assessed. Results In total, 67 procedures performed in 46 adults and 14 performed in 11 children were included in the analysis. In adults, 30 (65.2%) patients successfully reached their target preapheresis CD34+ cell count on day 1, with a median (interquartile range [IQR]) CD34+ collected cell dose of 4.8 × 106/kg (2.3‐10.6 × 106/kg). In the pediatric group, 81.8% successfully collected the target CD34+ cell dose on the first day, with a median (IQR) CD34+ collected cell dose of 11.1 × 106/kg (3.2‐16.3 × 106/kg). The customized algorithm showed a strong and significant linear correlation with actual CD34+ cell dose (P < 0.0001). Conclusion The results of this study support the use of LVL and the customized prediction algorithm in apheresis procedures. The ability to tailor the procedure to meet the needs of the individual patient may help to minimize the blood volume processed, shorten the duration, reduce the volume of infused anticoagulants, and improve patient comfort.

Advances in automated cell washing and concentration

“…A reproducible process is one that produces predictable outcomes. In the case of autologous products in which there is substantial intrinsic variation in starting material, a prediction algorithm may also be developed in guiding the manufacturing steps to achieve the desired product profile [25,26]. Process development requires substantial effort to identify and control the critical process parameters of the process, and multivariate analysis is sometimes essential.…”

Predictive factors of poor blood collecting flow during leukocyte apheresis for cellular therapy

“…initiation of apheresis [29,32]. The decrease in blood pressure due to the occurrence of poor blood collecting flow in this study might also be related to hypovolemia.…”

“…Despite this severe effect, the complications of poor blood collecting flow during leukocyte apheresis have not been sufficiently described, and studies regarding its underlying mechanism are lacking. Studies have shown that hypovolemia may occur during the procedure of apheresis [1,5,[29][30][31]. This occurs if a patient is intolerant to the large shift in extracorporeal blood and plasma volumes [1,29], which subsequently slows the rate of apheresis or temporarily stops it; therapy using intravenous fluid boluses or similar is required in such cases [1].…”

“…Studies have shown that hypovolemia may occur during the procedure of apheresis [1,5,[29][30][31]. This occurs if a patient is intolerant to the large shift in extracorporeal blood and plasma volumes [1,29], which subsequently slows the rate of apheresis or temporarily stops it; therapy using intravenous fluid boluses or similar is required in such cases [1]. Therefore, low blood collecting flow developing in a relatively short time after the start of leukocyte apheresis might be associated with hypovolemia due to the extracorporeal blood volume after Bold type: statistical significance (P < 0.05).…”

Impact of custom prime on the PBSC collection efficiency and procedure outcome on Spectra Optia apheresis device by using the CMNC program in low-weight pediatric oncology patients. A single-center experience

“…Nevertheless, the cell yield predictability in the LBV group, based on coefficient of determination (R 2 ), is 96% (Table 1) and is approaching the values in adults [11], whereas, in whole cohort of patients, the R 2 can explain only 84% of variation in CD34+ yield, which is in line with pediatric data in study of Bojanić et al [11]. For VLBV group, only 85% can be explained by the prediction algorithm, showing that this subgroup of patients is contributing for the lower cell yield predictability in pediatric patients.…”