An Automated Device for High Yield Mesenchymal Stem Cell Extraction

高产间充质干细胞提取自动化设备

• 批准号: 9049407
• 负责人: Harun Elmasri
• 金额: $ 19.99万
• 依托单位: CG SCIENTIFIC, INC.
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-01 至 2017-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9049407
• 关键词: Adipose tissue; Allogenic; Area; Autologous; Automation; Biotechnology; Cell Separation; Characteristics; Clinical; Clinical Trials; Data; Devices; Diabetes Mellitus; Digestion; Disease; Disease model; Dose; Enzymes; Excision; Health; Human; Immune response; Immune system; Lateral; Legal patent; Life; Liver Cirrhosis; Medical Device; Mesenchymal Stem Cells; Microfluidics; Molecular; Myocardial Infarction; Nature; Neoplasm Circulating Cells; Outcome; Phase; Physicians; Process; Protocols documentation; Publications; Recovery; Reporting; Research Personnel; Safety; Sampling; Science; Small Business Innovation Research Grant; Stem cells; System; Techniques; Technology; Tissues; Work; artemis; base; cell preparation; clinical application; clinically relevant; effective therapy; experience; graft vs host disease; humanized mouse; immunogenic; invention; liver transplantation; mouse model; novel; pre-clinical; preclinical efficacy; preclinical safety; preclinical study; prevent; prototype; public health relevance; standard of care; stem cell therapy; tissue repair; tool

 DESCRIPTION (provided by applicant): This project aims to develop an automated device for extracting mesenchymal stem cells (MSCs) in clinically relevant quantities from adipose tissues for treating many serious diseases, including myocardial infarction, diabetes, liver cirrhosis and graft-versus-host disease. Over 400 clinical trials to date have established the feasibility, safet, and in some cases efficacy of autologous and allogeneic MSC therapies to treat these diseases. However, the results are inconclusive due to the lack of standard and optimized MSC preparation protocols and the loss of MSC characteristics and functions as MSCs are extensively expanded. We have developed a concept prototype device to show that adipose tissue may contain at least an order of magnitude more MSCs than previously reported, opening the opportunity to use un-cultured primary MSCs as a high potency substitute for ex vivo expanded MSCs currently used in clinical trials. The device will have a unique configuration to (1) enable rapid and efficient enzyme digestion providing MSCs in clinically relevant quantities, (2) fully integrate MSC extraction steps of tissue washing, enzyme digestion, cell separation, and debris removal in a closed system format, and (3) enable automation readily, so that the MSC extraction process can be performed efficiently, safely and reproducibly. In Phase I, we will (1) optimize the prototype device and operating protocols to maximize viable MSC recovery, which is the most difficult and important step in MSC preparation, and (2) use the primary MSCs to prevent and treat graft versus host disease (GVHD) in a humanized mouse model as an example to demonstrate the preclinical safety and efficacy of our primary MSCs. Our team includes medical device experts, stem cell biologists, humanized mouse experts, and physicians who have worked together successfully on multiple projects. The proposed device represents an essential tool for enabling MSC therapies to be highly effective and ultimately the standard of care for treating many life-threatening and hard-to-treat diseases.

 描述（由适用提供）：该项目旨在开发一种自动化装置，用于从脂肪组织中提取间充质干细胞（MSC），以治疗许多严重疾病，包括心肌梗塞，糖尿病，肝脏cirrhosis和Grass抗癌 - 伴随性疾病。迄今为止，已有400多次临床试验确定了自体和同种异体MSC疗法的可行性，安全性，并确定了治疗这些疾病的有效性。但是，由于缺乏标准和优化的MSC制备方案以及MSC特征的丢失和功能，由于MSC广泛扩展，因此结果尚无定论。我们已经开发了一种概念方案设备，以表明脂肪组织可能至少包含比以前报道的MSC的数量级，这为使用未培养的主要MSC作为当前在临床试验中使用的EX VIVO扩展的MSC的高效替代品开放了机会。 The device will have a unique configuration to (1) enable rapid and efficient enzyme digestion providing MSCs in clinically relevant quantities, (2) fully integrated MSC extraction steps of tissue washing, enzyme digestion, cell separation, and debris removal in a closed system format, and (3) enable automation readily, so that the MSC extraction process can be performed efficiently, safely and reproducibly.在第一阶段，我们将（1）优化原型设备和操作方案，以最大化可行的MSC恢复，这是MSC制备中最困难和最重要的一步，以及（2）使用主要MSC预防和治疗人文化小鼠模型中的图形与宿主疾病（GVHD），以证明我们原始MSC的临时安全性和有效性。我们的团队包括医疗器械专家，干细胞生物学家，人源化的老鼠专家以及成功在多个项目上合作的医生。所提出的设备代表了使MSC疗法高效的重要工具，最终是治疗许多威胁生命和难以治疗的疾病的护理标准。