Novel strategies for storage and recovery of cadaveric bone marrow stem cells

尸体骨髓干细胞储存和恢复的新策略

• 批准号: 9910145
• 负责人: ERIK J. WOODS
• 金额: $ 77.87万
• 依托单位: OSSIUM HEALTH, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-03-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9910145
• 关键词: Address; Adoption; Allografting; Aspirate substance; B-Lymphocytes; Basic Science; Biological Specimen Banks; Blood Banks; Blood Vessels; Bone Banks; Bone Marrow; Bone Marrow Aspiration; Bone Marrow Cells; Bone Marrow Stem Cell; Bone Marrow Transplantation; Cadaver; Cell Separation; Cells; Cessation of life; Child; Clinical; Clinical Research; Clinical Trials; Communicable Diseases; Complement; Complex; Cost Savings; Cryopreservation; Cryopreserved Cell; Dendritic Cells; Dimethyl Sulfoxide; Disease; Ecosystem; Generations; Genetic Variation; Gifts; HLA Antigens; Health; Hematopoietic; Hematopoietic Stem Cell Transplantation; Hematopoietic stem cells; Hospitals; In Situ; Industrialization; Infrastructure; Injury; Investigation; Life; Living Donors; Manuals; Marrow; Mesenchymal Stem Cells; Methods; Minority; Modeling; Mus; Natural Killer Cells; Organ; Organ Donor; Organ Procurements; Patients; Phase; Physicians; Procedures; Process; Production; Ramp; Recovery; Registries; Reproducibility of Results; Research; Research Personnel; Resources; Savings; Source; Specimen; Sterility; System; T-Lymphocyte; Technology; Therapeutic; Therapeutic Human Experimentation; Time; Tissue Donors; Tissue Engineering; Tissues; Umbilical Cord Blood; United States Health Resources and Services Administration; Vacuum; Woman; Work; bone; cell type; cost; gene therapy; health disparity; human leukocyte antigen testing; improved; innovation; interest; novel; novel strategies; peripheral blood; phase 2 study; progenitor; protective effect; stem; stem cells; trial comparing; vertebra body

ABSTRACT Bone marrow represents a rich source of diverse stem, progenitor and other cells of clinical and research interest including hematopoietic stem cells (HSC) and mesenchymal stem cells (MSC), dendritic cells, T-cells, natural killer (NK) cells, B-cells and others. Currently, these cells are only recovered from living donors through bone marrow aspiration or peripheral blood mobilization. Ossium Health is developing the first clinical and research bank of bone marrow derived cells from deceased organ and tissue donors. While the concept of utilizing this resource for bone marrow cells was first described over 60 years ago, the ability to recover viable material efficiently and the infrastructure necessary to achieve this at even a modest scale simply has not existed. Ossium Health has overcome this by establishing a robust ecosystem comprised of a world-class tissue processor (and Phase III partner), major organ procurement agencies and innovation to, for the first time, allow recovery and banking of this plentiful source of potentially life-saving cells. However, for this bank to reach its full potential, further efficiencies must be advanced and implemented. This Phase II study aims to develop “smart baking” innovations by optimizing methods of cryopreserving intact marrow in situ within whole bones to allow time for infectious disease, sterility and HLA testing prior to investing in fully processing donor bones to isolate cellular components. This innovative work will also provide early guidance towards cryopreservation of more complex tissues such as vascular composite allografts (VCA). The resulting technology from this study may increase efficiency by as much as 80% - drastically reducing cost and allowing more readily available and less expensive clinical grade and high-quality research material to be available to meet the growing demands of gene therapy, tissue engineering and basic science investigation.

摘要 骨髓是各种干细胞、祖细胞和其他临床和研究感兴趣的细胞的丰富来源。 包括造血干细胞(HSC)和间充质干细胞(MSC)，树突状细胞，T细胞，天然 杀手(NK)细胞、B细胞和其他。目前，这些细胞只能通过骨骼从活体捐赠者身上回收。 骨髓抽吸术或外周血动员。铯健康正在开发第一个临床和研究 来自已故器官和组织捐赠者的骨髓来源细胞库。虽然利用这一点的概念 60多年前首次描述了骨髓细胞的来源，即回收活性物质的能力 而实现这一目标所需的基础设施即使是适度的规模也根本不存在。铯 Health已经克服了这一点，建立了一个由世界级组织处理器(和 第三阶段合作伙伴)、主要器官采购机构和创新，以首次允许恢复和 储存这些可能挽救生命的丰富细胞来源。然而，这家银行要充分发挥其潜力， 必须进一步提高和实施效率。这项第二阶段的研究旨在发展“智能烘焙”。 通过优化在整个骨骼内原位冷冻保存完整骨髓的方法进行创新，以便有时间 在投资完全处理供体骨骼以分离细胞之前，进行传染病、不孕症和人类白细胞抗原测试 组件。这项创新性的工作也将为更复杂的冷冻保存提供早期指导 血管复合同种异体移植(VCA)等组织。这项研究产生的技术可能会增加 效率提高高达80%-大幅降低成本，并允许更容易获得且成本更低 临床级别和高质量的研究材料，以满足日益增长的基因治疗需求， 组织工程和基础科学研究。