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评估一种用于造血干细胞采集管理的新计数方法的多中心研究。

Multicenter study to evaluate a new enumeration method for hematopoietic stem cell collection management.

作者信息

Grommé Monique, Russcher Henk, Braakman Eric, Klinkspoor J Henriëtte, Dobber Johan A, de Greef Inge, de Wit Norbert C J

机构信息

Department of Internal Medicine, Division of Haematology, Erasmus Medical Centre, Rotterdam, the Netherlands.

Clinical Chemistry, Erasmus Medical Centre, Rotterdam, the Netherlands.

出版信息

Transfusion. 2017 Aug;57(8):1949-1955. doi: 10.1111/trf.14183. Epub 2017 Jun 26.

DOI:10.1111/trf.14183
PMID:28653370
Abstract

BACKGROUND

CD34 flow cytometry is the gold standard for stem cell enumeration in peripheral blood at the mobilization stage and in the final apheresis product. The new stem cell mode of the Sysmex XN Series analyzer enumerates an immature cell population in the white progenitor and pathological cell (WPC) channel, based on the cell size, internal cellular complexity, and fluorescence intensity.

STUDY DESIGN AND METHODS

In this multicenter study we analyzed 147 peripheral blood samples, 22 samples during collection of stem cells, and 45 samples from the apheresis product of 18 healthy allogeneic donors and 84 autologous patients.

RESULTS

In this multicenter study we demonstrate that the XN stem cell enumeration method correlates well with viable CD34+ cells determined by flow cytometry during the stem cell mobilization phase to determine apheresis start time, during apheresis for real-time monitoring and adjustment, and for quality control of the final stem cell harvest.

CONCLUSION

Our data show that there is an improvement in the correlation of XN stem cells and CD34+ cells in the peripheral blood during stem cell mobilization as well as in stem cell harvests compared to SE or XE Series analyzers. The XN stem cell enumeration method has a number of advantages compared to CD34 flow cytometry: it is fast, simple, reproducible, and less expensive. CE marking for the European market has been obtained, making the stem cell count on the XN analyzer a reportable clinical variable.

摘要

背景

CD34流式细胞术是在动员阶段外周血及最终单采产品中进行干细胞计数的金标准。Sysmex XN系列分析仪的新干细胞模式基于细胞大小、细胞内部复杂性和荧光强度,在白细胞祖细胞和病理细胞(WPC)通道中对未成熟细胞群体进行计数。

研究设计与方法

在这项多中心研究中,我们分析了147份外周血样本、22份干细胞采集过程中的样本以及来自18名健康异体供者和84名自体患者单采产品的45份样本。

结果

在这项多中心研究中,我们证明XN干细胞计数方法与流式细胞术测定的活CD34+细胞在干细胞动员阶段确定单采开始时间、单采过程中进行实时监测和调整以及最终干细胞采集的质量控制方面具有良好的相关性。

结论

我们的数据表明,与SE或XE系列分析仪相比,在干细胞动员期间以及干细胞采集过程中,XN干细胞与外周血中CD34+细胞的相关性有所提高。XN干细胞计数方法与CD34流式细胞术相比具有许多优势:快速、简单、可重复且成本较低。已获得欧洲市场的CE标志,使得XN分析仪上的干细胞计数成为可报告的临床变量。

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引用本文的文献

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J Blood Med. 2024 Aug 22;15:387-394. doi: 10.2147/JBM.S460820. eCollection 2024.
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Hematopoietic Progenitor Cell Counts of the Leukapheresis Product Determined Using Sysmex XN Analyzers Predict a Sufficient Number of CD34 Stem Cells in a Peripheral Blood Stem Cell Harvest for Autologous Transplantation.使用希森美康 XN 分析仪测定的白细胞去除产物中的造血祖细胞计数可预测自体移植中外周血干细胞采集的 CD34 干细胞数量是否充足。
Intern Med. 2024 Jan 15;63(2):189-195. doi: 10.2169/internalmedicine.1697-23. Epub 2023 May 24.
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Blood Transfus. 2020 Jan;18(1):67-76. doi: 10.2450/2019.0086-19. Epub 2019 Jul 25.