Autologous stem cell transplant has been used with variable success rates in the treatment of different malignancies. One of the potential causes of relapse is contamination of the stem cell collection by neoplastic cells. Purging the stem cells by CD34+ selection has been used to reduce such contamination. In this study two different devices were compared in their efficiency to achieve CD34+ selection of peripheral blood stem cells collected in individuals undergoing autologous transplant for breast cancer, neuroblastoma, plasma cell dyscrasia, lymphoma (both Hodgkin and non Hodgkin), rhabdomyosarcoma and amyloidosis. A total of 28 patients were randomized to CD34 selection on the Nexell Isolex 300i® system (NIS) or the Miltenyi Biotec CliniMACS® (MCMS) system. The prevalence of plasma cell dyscrasia was higher in the MCMS group (57%) than in the NIS group (22%). On the other hand, there were 2 cases of Hodgkin lymphoma and 2 cases of breast cancer in the NIS group, in comparison to none in the MCMS group. Average values for parameters of selection efficacy for the 19 patients transplanted are shown in table 1 (recovery = number of cells post / number of cells pre-selection X 100, viability measured with the trypan blue exclusion test). Transplant was done as per local protocols according to the type of malignancy. CD34+ cell dose was determined by institutional guidelines. Average values for engraftment are shown in table 2 (two patients who died before engraftment in the MCMS group were excluded from calculation of the mean values). One patient died of graft failure in the MCMS group in contrast to none in the NIS group. Although the numbers of patients are relatively low, this is the first randomized study in which the selection efficiency of the NIS and MCMS devices have been compared in patients receiving CD34-selected autografts. CFU-GM recovery and cell viability were lower, while neutrophil engraftment was slower in the MCMS group, but these differences were not statistically significant. Our data do not show any clinically significant advantage for either the NIS or MCMS selection device.

Table 1
DeviceCD34+ recovery (%,range)CFU-GEMM recovery (%,range)CFU-GM recovery (%,range)Viability pre (%,range)Viability post (%,range)
P-value calculated with Student’s t-Test. 
NIS 52 (16–76) 5 (1–14) 9 (0–42) 95 (91–99) 95 (90–99) 
MCMS 66 (48–75) 4 (1–5) 5 (0–9) 94 (80–99) 88 (60–100) 
P 0.17 0.71 0.57 0.69 0.16 
DeviceCD34+ recovery (%,range)CFU-GEMM recovery (%,range)CFU-GM recovery (%,range)Viability pre (%,range)Viability post (%,range)
P-value calculated with Student’s t-Test. 
NIS 52 (16–76) 5 (1–14) 9 (0–42) 95 (91–99) 95 (90–99) 
MCMS 66 (48–75) 4 (1–5) 5 (0–9) 94 (80–99) 88 (60–100) 
P 0.17 0.71 0.57 0.69 0.16 
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Table 2
DeviceCD34+ infused (X 106/kg, range)Time to ANC ≥500 (days, range)Time to plt ≥20 (days, range)# Units plt
P-value calculated with Student’s t-Test. 
NIS 3.6 (2.0–5.2) 12.2 (9–20) 15.9 (11–38) 19.4 (0–30) 
MCMS 3.6 (1.5–5.1) 15.1 (11- ∞) 16.8 (9-∞) 40.2 (6–150) 
P - 0.22 0.79 0.23 
DeviceCD34+ infused (X 106/kg, range)Time to ANC ≥500 (days, range)Time to plt ≥20 (days, range)# Units plt
P-value calculated with Student’s t-Test. 
NIS 3.6 (2.0–5.2) 12.2 (9–20) 15.9 (11–38) 19.4 (0–30) 
MCMS 3.6 (1.5–5.1) 15.1 (11- ∞) 16.8 (9-∞) 40.2 (6–150) 
P - 0.22 0.79 0.23 
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Topics:
cd34 antigens, peripheral blood stem cell transplantation, hodgkin's disease, medical devices, breast cancer, cancer, dysproteinemia, plasma cell disorder, transplantation, amyloidosis

Author notes

Corresponding author

2005, The American Society of Hematology
2005
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