Shu Z, Heimfeld S, Gao D
Department of Mechanical Engineering and Department of Bioengineering, University of Washington, Seattle, WA, USA.
Division of Clinical Research, Fred Hutchinson Cancer Research Center, Seattle, WA, USA.
Bone Marrow Transplant. 2014 Apr;49(4):469-76. doi: 10.1038/bmt.2013.152. Epub 2013 Sep 30.
Transplantation of hematopoietic stem cells (HSCs) has been successfully developed as a part of treatment protocols for a large number of clinical indications, and cryopreservation of both autologous and allogeneic sources of HSC grafts is increasingly being used to facilitate logistical challenges in coordinating the collection, processing, preparation, quality control testing and release of the final HSC product with delivery to the patient. Direct infusion of cryopreserved cell products into patients has been associated with the development of adverse reactions, ranging from relatively mild symptoms to much more serious, life-threatening complications, including allergic/gastrointestinal/cardiovascular/neurological complications, renal/hepatic dysfunctions, and so on. In many cases, the cryoprotective agent (CPA) used-which is typically dimethyl sulfoxide (DMSO)-is believed to be the main causal agent of these adverse reactions and thus many studies recommend depletion of DMSO before cell infusion. In this paper, we will briefly review the history of HSC cryopreservation, the side effects reported after transplantation, along with advances in strategies for reducing the adverse reactions, including methods and devices for removal of DMSO. Strategies to minimize adverse effects include medication before and after transplantation, optimizing the infusion procedure, reducing the DMSO concentration or using alternative CPAs for cryopreservation and removing DMSO before infusion. For DMSO removal, besides the traditional and widely applied method of centrifugation, new approaches have been explored in the past decade, such as filtration by spinning membrane, stepwise dilution-centrifugation using rotating syringe, diffusion-based DMSO extraction in microfluidic channels, dialysis and dilution-filtration through hollow-fiber dialyzers and some instruments (CytoMate, Sepax S-100, Cobe 2991, microfluidic channels, dilution-filtration system, etc.) as well. However, challenges still remain: development of the optimal (fast, safe, simple, automated, controllable, effective and low cost) methods and devices for CPA removal with minimum cell loss and damage remains an unfilled need.
造血干细胞(HSCs)移植已成功发展成为众多临床适应症治疗方案的一部分,自体和异基因来源的HSC移植物的冷冻保存越来越多地用于应对在协调最终HSC产品的采集、处理、制备、质量控制检测和放行以及交付给患者过程中的后勤挑战。将冷冻保存的细胞产品直接输注到患者体内与不良反应的发生有关,不良反应范围从相对较轻的症状到更为严重的、危及生命的并发症,包括过敏/胃肠道/心血管/神经并发症、肾/肝功能障碍等。在许多情况下,所使用的冷冻保护剂(CPA)——通常是二甲基亚砜(DMSO)——被认为是这些不良反应的主要致病因素,因此许多研究建议在细胞输注前去除DMSO。在本文中,我们将简要回顾HSC冷冻保存的历史、移植后报告的副作用,以及减少不良反应的策略进展,包括去除DMSO的方法和装置。将不良反应降至最低的策略包括移植前后用药、优化输注程序、降低DMSO浓度或使用替代CPA进行冷冻保存以及在输注前去除DMSO。对于DMSO的去除,除了传统且广泛应用的离心方法外,在过去十年中还探索了新的方法,如旋转膜过滤、使用旋转注射器的逐步稀释 - 离心、微流控通道中基于扩散的DMSO提取、透析以及通过中空纤维透析器和一些仪器(CytoMate、Sepax S - 100、Cobe 2991、微流控通道、稀释 - 过滤系统等)进行稀释 - 过滤。然而,挑战依然存在:开发最佳(快速、安全、简单、自动化、可控、有效且低成本)的去除CPA的方法和装置,同时将细胞损失和损伤降至最低,这一需求仍未得到满足。