Hypoxia-Perfusion Bioreactor for Stem Cell Applications

用于干细胞应用的缺氧灌注生物反应器

• 批准号: 7910633
• 负责人: TODD A MCADAMS
• 金额: $ 37.08万
• 依托单位: RESODYN CORPORATION
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-14 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7910633
• 关键词: Adipose tissue; Adult; Affect; Agitation; Anoxia; Antigen-Presenting Cells; Biological; Bioreactors; Biotechnology; Businesses; CD34 gene; California; Cell Count; Cell Culture System; Cell Culture Techniques; Cell Density; Cell Line; Cell Therapy; Cells; Characteristics; Chinese Hamster; Chinese Hamster Ovary Cell; Clinic; Controlled Study; Cytoskeleton; Development; Devices; Equipment; Evaluation; Feedback; Fiber; Gases; Goals; Government; Hematopoietic; Hematopoietic stem cells; Hybridomas; Hypoxia; Immunotherapy; Laboratories; Laboratory Research; Letters; Ligands; Liquid substance; Mammalian Cell; Marketing; Mesenchymal; Mesenchymal Stem Cells; Metabolic; Modeling; Molds; Monitor; Monoclonal Antibodies; Mononuclear; Nutrient; Optics; Outcome; Ovary; Oxygen; Performance; Perfusion; Persons; Phase; Polystyrenes; Population; Primary Cell Cultures; Probability; Production; Protocols documentation; Provider; Recombinant Proteins; Reporting; Reproducibility; Research; Research Infrastructure; Research Personnel; Risk; Sales; Sampling; Small Business Innovation Research Grant; Source; Stem Cell Development; Stem Cell Factor; Stem cells; Suspension substance; Suspensions; System; Technology; Testing; Therapeutic; Therapeutic Human Experimentation; Therapeutic Monoclonal Antibodies; Therapeutic Studies; Thrombopoietin; Tissue Engineering; Translations; Transplantation; Universities; Valproic Acid; adult stem cell; cell type; cellular engineering; commercialization; cost; cytokine; density; design; embryonic stem cell; feeding; human disease; instrument; manufacturing process; meetings; monoclonal antibody production; novel; physical conditioning; programs; prototype; public health relevance; relating to nervous system; research study; scale up; self-renewal; sensor; shear stress; stem; stem cell biology; stem cell niche; stem cell population; stem cell therapy; tool

DESCRIPTION (provided by applicant): This Small Business Innovation Research Phase I project will develop and demonstrate a prototype Hypoxia Perfusion Bioreactor (HPB). In order to utilize recent discoveries that low oxygen levels are favorable to stem cell expansion, Resodyn Corporation has developed the HPB, which is designed to provide controlled delivery of both oxygen and fresh medium to stem cell cultures. Studying and controlling the physical parameters are essential in order to bring reproducible, economically feasible therapies to the clinic. One goal of this Phase II proposal is to evaluate and demonstrate the utility and commercial feasibility of Resodyn Corporation's Hypoxia Perfusion Bioreactor (HPB) for wide range of hematopoietic cell expansion applications. A second goal is to develop a model protocol that will demonstrate the HPB's ability to expand hematopoietic stem cells (HSCs) without the requirement for previous selection (CD34+ or AC133+) for primitive stem cell populations. This capability would represent a significant advance in reducing the cost and complexity of therapeutic and research efforts in the stem cell field. While the primary feasibility of the HPB will be tested primarily with hematopoietic cell populations, the benefits of this device (controlled hypoxia/oxygen levels, high cell densities, reduced labor, lower contamination risk) would have extended utility to other types of stem and progenitor cells (mesenchymal, adipose, neural, etc.), as well as for use in general mammalian cell culture. Such applications include hybridoma culture for monoclonal antibody (MAb) production and Chinese Hamster Ovary (CHO) cell culture for production of recombinant proteins. The HPB system has significant long-term commercial potential both in the laboratory as a tool to facilitate development of stem cells protocols, and in the clinic as a component of both hematopoietic transplantation and other pre-emerging stem cell therapies of the neural, hematopoietic, and mesenchymal lineages. PUBLIC HEALTH RELEVANCE: This Small Business Innovation Research Phase I project will develop and demonstrate a Hypoxia Perfusion Bioreactor (HPB). The HPB is a single-use bioreactor designed specifically for stem cell and other primary cell cultures and can substantially reduce labor costs and reduce contamination risks associated with the scale-up of cellular therapies. The HPB will reduce costs and ease the translation of stem cell therapies from the research lab to the clinic.

描述（由申请人提供）：这个小企业创新研究第一阶段项目将开发和展示一个原型缺氧灌注生物反应器（HPB）。为了利用低氧水平有利于干细胞扩增的最新发现，Resodyn Corporation开发了HPB，其设计用于向干细胞培养物提供氧气和新鲜培养基的受控递送。研究和控制物理参数是必不可少的，以便为临床带来可重复的，经济可行的治疗。该II期提案的一个目标是评估和证明Resodyn Corporation的低氧灌注生物反应器（HPB）用于广泛的造血细胞扩增应用的实用性和商业可行性。第二个目标是开发一种模型方案，该方案将证明HPB扩增造血干细胞（HSC）的能力，而不需要对原始干细胞群体进行先前的选择（CD 34+或AC 133+）。这种能力将代表在降低干细胞领域治疗和研究工作的成本和复杂性方面的重大进步。虽然HPB的主要可行性将主要用造血细胞群进行测试，但该装置的益处（受控的缺氧/氧水平、高细胞密度、减少的劳动、较低的污染风险）将扩展到其他类型的干细胞和祖细胞（间充质细胞、脂肪细胞、神经细胞等），以及用于一般的哺乳动物细胞培养。此类应用包括用于单克隆抗体（MAb）生产的杂交瘤培养和用于重组蛋白生产的中国卵巢（CHO）细胞培养。HPB系统在实验室中作为促进干细胞方案开发的工具，以及在临床中作为造血移植和神经、造血和间充质谱系的其他预出现干细胞疗法的组成部分，都具有显著的长期商业潜力。公共卫生相关性：这个小企业创新研究第一阶段项目将开发和展示低氧灌注生物反应器（HPB）。HPB是专为干细胞和其他原代细胞培养设计的一次性生物反应器，可以大幅降低劳动力成本，并降低与细胞治疗规模扩大相关的污染风险。HPB将降低成本，并简化干细胞疗法从研究实验室到临床的转化。