Isolation of highly purified autologous and allogeneic peripheral CD34+ cells using the CliniMACS device

The CliniMACS(TM) CD34(+) selection device was used for positive selection of apheresis products for autologous transplantation from 10 patients with malignant diseases and for allogeneic transplantation from 26 healthy donors, A total of 71 separations were performed. In 1 allogeneic donor, CD34(+) progenitors were also isolated from bone marrow. Between 0.27 and 8.9 x 10(10) nucleated cells (median 4.9 x 10(10)) containing 0.09%-10.8% (median 0.67%) CD34(+) progenitor cells were separated, After separation, a median number of 227 x 10(6) mononuclear cells (MNC) (51-524) were recovered, with a median viability of 99% (22%-100%) and a median purity of 97.0% (68.3%-99.7%) CD34(+) cells. Depletion of T cells was extensive, with a median of 0.04% residual CD3(+) cells (range <0.01%-0.92%). Residual CD19(+) cells were between <0.01% and 17%, including CD34(+)CD19(+) cells. Recovery of CD34(+) cells was calculated according to the ISHAGE guidelines and ranged from 24% to 105% (median 71%), We conclude that with the CliniMACS(TM) device CD34(+) cells with high purity and recovery can be isolated with concomitant effective T cell depletion in the allogeneic setting and with a high purging efficacy in the autologous setting.