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自动接口控制的造血干细胞/祖细胞采集:新型干细胞采集设备的自体供者验证试验结果。

Automatic interface-controlled apheresis collection of stem/progenitor cells: results from an autologous donor validation trial of a novel stem cell apheresis device.

机构信息

German Red Cross Blood Service Baden-Württemberg-Hessen and Institute of Clinical Transfusion Medicine and Immunogenetics, University of Ulm, Ulm, Germany.

出版信息

Transfusion. 2011 Jun;51(6):1321-30. doi: 10.1111/j.1537-2995.2010.02992.x. Epub 2010 Dec 13.

DOI:10.1111/j.1537-2995.2010.02992.x
PMID:21155834
Abstract

BACKGROUND

Cryopreserved hematopoietic progenitor cells collected by apheresis from granulocyte-colony-stimulating factor with or without chemotherapy-mobilized patients have become the preferred type of autograft to support treatment of diseases amenable to high-dose chemotherapy. A novel apheresis system, the Spectra Optia v.5.0 (CaridianBCT), was constructed to meet certain shortcomings of manual apheresis systems such as the COBE Spectra MNC (CaridianBCT), including the need for continuous optical or manual monitoring and readjustment of buffy coat position and sensitivity to inconsistent blood flow. By use of optical sensors, which provide real-time automatic interface (buffy coat) and collection line control, the Spectra Optia promises to automatically guide apheresis procedures, potentially freeing up operator time and reducing variability in collection efficiency (CE2).

STUDY DESIGN AND METHODS

In a two-center clinical trial, 35 autologous stem cell donors were subjected to apheresis with the Spectra Optia to validate feasibility and effectiveness of apheresis procedures. Results were compared to data from 80 autologous apheresis procedures with the COBE Spectra MNC.

RESULTS

Usability and function of the automatic interface management were excellent. CD34+ cell quality, assessed by viability staining, colony-forming unit-culture frequency, and engraftment kinetics, was equally good with both systems. CE2 of the Spectra Optia, calculated as CD34+ contents in the product divided by the number of CD34+ cells presented to the collection port, exceeded that of the COBE Spectra MNC. Spectra Optia product volumes were significantly smaller. Very high white blood cell and platelet counts modestly reduced CE2 with the Spectra Optia.

CONCLUSION

The Spectra Optia is a novel automatic apheresis system supporting autologous stem cell collection with at least equal efficiency and superior user-friendliness compared to the COBE Spectra MNC.

摘要

背景

通过粒细胞集落刺激因子联合或不联合化疗动员的患者进行外周血造血祖细胞采集,经低温保存后用于自体移植,已成为支持大剂量化疗治疗疾病的首选类型。一种新型的外周血分离系统——Spectra Optia v.5.0(CaridianBCT)被构建出来,以满足手动分离系统的某些缺点,如 COBE Spectra MNC(CaridianBCT),包括需要连续光学或手动监测和调整白细胞层的位置以及对血流不一致的敏感性。该系统使用光学传感器提供实时自动接口(白细胞层)和收集线控制,有望自动指导外周血分离程序,从而节省操作人员的时间,并减少采集效率(CE2)的变异性。

研究设计和方法

在一项两中心临床试验中,35 名自体干细胞供者接受了 Spectra Optia 外周血分离,以验证分离程序的可行性和有效性。结果与 80 例 COBE Spectra MNC 自体分离的数据进行了比较。

结果

自动接口管理的可用性和功能非常出色。通过活力染色、集落形成单位培养频率和植入动力学评估,两种系统的 CD34+细胞质量均良好。Spectra Optia 的 CE2 计算为产品中 CD34+细胞含量除以收集端口处呈现的 CD34+细胞数量,高于 COBE Spectra MNC。Spectra Optia 的产品体积明显较小。非常高的白细胞和血小板计数适度降低了 Spectra Optia 的 CE2。

结论

Spectra Optia 是一种新型的自动外周血分离系统,与 COBE Spectra MNC 相比,支持自体干细胞采集,具有至少同等的效率和更高的用户友好性。

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