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《骨髓采集器:一种新颖的微创、高效的骨髓采集装置》。

The MarrowMiner: A Novel Minimally Invasive and Effective Device for the Harvest of Bone Marrow.

机构信息

RegenMed Systems, Palo Alto, California.

Department of Pediatrics, Division of Stem Cell Transplantation and Regenerative Medicine, School of Medicine, Stanford University, Stanford, California; Institute for Stem Cell Biology and Regenerative Medicine, Stanford University School of Medicine, Stanford, California.

出版信息

Biol Blood Marrow Transplant. 2020 Feb;26(2):219-229. doi: 10.1016/j.bbmt.2019.08.027. Epub 2019 Sep 3.

Abstract

Bone marrow (BM) is a rich source of hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), and other important stem/progenitor cells. It is the traditional source of cells used in hematopoietic cell transplantation, which is a proven curative treatment for many blood and immune diseases. BM-derived cells have also been shown to have other diverse clinical uses and are increasingly being used in orthopedic medicine, regenerative medicine, and gene therapy applications. Traditional methods for harvesting BM are crude, tedious, time-consuming, and expensive, requiring multiple bone punctures under general anesthesia with serial small-volume aspirates often diluted with peripheral blood. The MarrowMiner (MM) is a novel device designed for rapid and minimally invasive BM harvest. Here we show the safety and efficacy of the MM in both preclinical and clinical settings. In a large-animal porcine model, the MM enabled effective BM collection with similar total nucleated cell collection and increased colony formation compared with standard methods. The MM was subsequently evaluated in a clinical study showing effective and complication-free anterior and posterior BM collection of 20 patients under only local anesthesia or light sedation. Increased total nucleated and mononucleated cell collection was achieved with the MM compared with standard methods in the same patients. Importantly, stem cell content was high with trends toward increased HSC, MSC, and endothelial progenitor cells with similar T cell content. Given the MM is a novel device approved by the US Food and Drug Administration, enabling safe, effective, and minimally invasive harvest of BM, we anticipate rapid adoption for various applications.

摘要

骨髓(BM)是造血干细胞(HSCs)、间充质干细胞(MSCs)和其他重要干细胞/祖细胞的丰富来源。它是用于造血细胞移植的传统细胞来源,造血细胞移植已被证明是许多血液和免疫疾病的有效治疗方法。BM 来源的细胞也具有其他多样化的临床用途,并越来越多地用于骨科医学、再生医学和基因治疗应用。传统的 BM 采集方法粗糙、繁琐、耗时且昂贵,需要在全身麻醉下多次进行骨穿刺,并且通常需要用外周血进行多次小体积抽吸以进行稀释。MarrowMiner(MM)是一种用于快速微创 BM 采集的新型设备。在这里,我们展示了 MM 在临床前和临床环境中的安全性和有效性。在大型动物猪模型中,与标准方法相比,MM 能够有效地采集 BM,总核细胞采集量相似,但集落形成增加。随后,在一项临床研究中评估了 MM,该研究显示 20 名患者仅在局部麻醉或轻度镇静下即可安全有效地从前部和后部采集 BM,而无需进行骨髓穿刺。与标准方法相比,MM 可增加总核细胞和单核细胞的采集量。重要的是,与 T 细胞含量相似,MM 中的干细胞含量较高,具有增加 HSC、MSC 和内皮祖细胞的趋势。鉴于 MM 是一种获得美国食品和药物管理局批准的新型设备,能够安全、有效、微创地采集 BM,我们预计它将很快在各种应用中得到广泛采用。

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