Després D, Flohr T, Uppenkamp M, Baldus M, Hoffmann M, Huber C, Derigs H G
University Hospital Mainz, IIIrd Department of Internal Medicine, Germany.
J Hematother Stem Cell Res. 2000 Aug;9(4):557-64. doi: 10.1089/152581600419242.
Several devices for selection of CD34+ peripheral blood stem cells (PBSC) have been used during the last years for reducing tumor cell contamination of the graft. The new CliniMACS system (magnetic-activated cell separation system by Miltenyi Biotech GmbH, Bergisch-Gladbach, Germany) was recently approved for clinical use in Europe. To evaluate its purging efficiency and engraftment data in the autologous transplant, PBSC from 28 adult patients with various malignant diseases (non-Hodgkin's lymphoma, n = 17; chronic lymphocytic leukemia, n = 5; multiple myeloma, n = 4; acute lymphocytic leukemia, n = 1; medulloblastoma, n = 1) were mobilized by chemotherapy and granulocyte colony-stimulating factor (G-CSF) (10 microg/kg per day). Thirty leukapheresis products from 28 patients with a median of 4.4 x 10(8) nucleated cells/kg body weight (bw)(range 0.6-10.8 x 10(8)/kg bw) and a median of 7.1 x 10(6) CD34+ cells/kg bw (range 2.8 to 18.8 x 10(6)/kg bw) were selected using the Cobe spectra cell separator (Cobe BCT Inc., Lakewood, CO). After the CliniMACS procedure, the median yield of CD34+ selected cells was 4.5 x 10(6)/kg (range 2.2-11.1 X 10(6)/kg bw) with a median recovery of 69.5% (range 46.9-87.3%) and a median purity of 97.7% (range 89.4-99.8%). The procedure did not alter viability of selected cells, which was tested by propidium iodide staining. So far, purified PBSC were used for autologous transplantation in 15 out of 28 patients after total body irradiation and/or high-dose chemotherapy. Median time to reach an absolute neutrophil count > 500/microl was 12 days (range 10-18 days), platelet recovery >50,000/microl occurred at day + 16 (range 11-22). With a median follow-up time of 12 months (range 3-19), 5 patients died of relapse. We confirmed the feasibility and safety of the CliniMACS CD34+ cell enrichment procedure in adult patients with autologous PBSC transplantation.
在过去几年中，已经使用了几种用于选择CD34+外周血干细胞（PBSC）的装置，以减少移植物中的肿瘤细胞污染。新型CliniMACS系统（德国贝吉施格拉德巴赫市Miltenyi Biotech GmbH公司的磁激活细胞分离系统）最近在欧洲被批准用于临床。为了评估其在自体移植中的清除效率和植入数据，对28例患有各种恶性疾病的成年患者（非霍奇金淋巴瘤，n = 17；慢性淋巴细胞白血病，n = 5；多发性骨髓瘤，n = 4；急性淋巴细胞白血病，n = 1；髓母细胞瘤，n = 1）的PBSC进行化疗和粒细胞集落刺激因子（G-CSF）（每天10μg/kg）动员。使用Cobe spectra细胞分离器（美国科罗拉多州莱克伍德市Cobe BCT公司）从28例患者中采集了30份白细胞分离产品，中位有核细胞数为4.4×10⁸/kg体重（bw）（范围0.6 - 10.8×10⁸/kg bw），中位CD34+细胞数为7.1×10⁶/kg bw（范围2.8至18.8×10⁶/kg bw）。经过CliniMACS程序后，CD34+选择细胞的中位产量为4.5×10⁶/kg（范围2.2 - 11.1×10⁶/kg bw），中位回收率为69.5%（范围46.9 - 87.3%），中位纯度为97.7%（范围89.4 - 99.8%）。该程序未改变所选细胞的活力，这通过碘化丙啶染色进行了检测。到目前为止，28例患者中有15例在全身照射和/或大剂量化疗后使用纯化的PBSC进行了自体移植。达到绝对中性粒细胞计数>500/μl的中位时间为12天（范围10 - 18天），血小板恢复至>50,000/μl发生在第16天（范围11 - 22天）。中位随访时间为12个月（范围3 - 19个月），5例患者死于复发。我们证实了CliniMACS CD34+细胞富集程序在成年自体PBSC移植患者中的可行性和安全性。
