Integrated training in development and clinical practice of cell-based therapies

细胞疗法开发和临床实践的综合培训

• 批准号: 9283633
• 负责人: ALLISON HUBEL
• 金额: $ 11.07万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-15 至 2020-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9283633
• 关键词: Aftercare; American; Antigens; Area; Autoimmune Diseases; Biological Assay; Biological Preservation; Blood; Cardiovascular system; Cell Therapy; Cells; Chemicals; Clinical; Communities; Competence; Contracts; Custom; Cyclic GMP; Development; Disease; Education; Educational workshop; Fellowship Program; Fostering; Growth; Health; Hematologic Neoplasms; Hematological Disease; Hematology; Hematopoietic; Hematopoietic Stem Cell Transplantation; Hematopoietic stem cells; Hemorrhage; Human; Immune; Immunotherapy; Injury; Lead; Manufactured Materials; Marrow; Medical; Medical Students; Medicine; Mesenchymal; Methods; Minnesota; Molecular; National Heart, Lung, and Blood Institute; Natural Killer Cells; Neurologic; Operative Surgical Procedures; Patients; Physicians; Positioning Attribute; Process; Production; Professional Organizations; Radiation; Red Cross; Research; Research Personnel; Resources; Role; Scientist; Stem cells; Stromal Cells; T-Cell Receptor; T-Lymphocyte; Techniques; Technology; Therapeutic; Therapeutic Studies; Time; Training; Training Programs; Transfusion; Translations; Trauma; Universities; base; bench to bedside; blood product; cellular development; chemotherapy; clinical practice; design; experience; improved; member; next generation; novel; programs; scale up; skills; stem; stem cell therapy; success; traditional therapy; visiting scholar; webinar

 DESCRIPTION (provided by applicant): The stem cell therapy market is valued at $2.7 billion, currently consisting largely of the hematopoietic stem cell (HSC) transplant market. HSC therapies are growing at roughly 10.6 % compound growth rate, and the advancement in stem cell therapies is broadening beyond the treatment of hematological malignancies into the treatment of cardiovascular, neurological, and other disorders. Blood products provide raw material for the manufacturing of several novel cell therapies, including stem cells and immune cell therapies. With promising early results in trials with natural killer (NK) cells, chimeric antgen receptor T-cells (CAR-T cells), antigen-specific T cells, mesenchymal stem/stromal cells, and others, the field will only continue to expand. With a decline in scientists in blood-based research, it is critical to the success of the field of cell therapy to focus efforts on training crrent researchers, as well as new investigators, perhaps contemplating a direction. New investigators as well as scientists who may be trained in the fundamentals of blood-based research may lack experience scaling up the techniques from the bench to the bedside. Specifically, they may not have experience in the advanced techniques used to process blood and stem-cell based therapies, and the sophisticated assays used for product characterization and post-treatment patient assessment. Furthermore, most investigators do not have experience with the regulatory requirements of cell-based therapies, a definite challenge in moving potential therapies from the bench to the bedside. An integrated education program in development and clinical practice of cell-based therapies would be instrumental in countering the decline of blood-based investigators and fostering advances in the treatment of hematological and other disease. The University of Minnesota (UM) is ideally positioned to provide such a program, with a proven track record of development of cellular therapies. The cGMP facility of the UM, Molecular & Cellular Therapeutics (MCT), has been highly successful as a member of the Production Assistance for Cellular Therapies (PACT) group, an NHLBI-sponsored contract. MCT has been an integral part of several well- received PACT webinars and facility workshops and education programs with professional organizations (e.g., AABB and ISCT) [3] and has educated numerous medical students, residents, fellows, and visiting scholars from around the world. The Biopreservation Core Resource (BioCoR) at the UM is the nations only resource in preservation and has training courses in preservation of cellular therapies and research into technology and methods of preservation for cellular therapies. These resources and a host makes the UM well suited to offer this short term educational experiences to enrich the hematology workforce. (End of Abstract)

 干细胞治疗市场价值27亿美元，目前主要由造血干细胞（HSC）移植市场组成。HSC疗法正以大约10.6%的复合增长率增长，干细胞疗法的进展正在从血液恶性肿瘤的治疗扩展到心血管、神经和其他疾病的治疗。血液制品为制造几种新型细胞疗法提供了原材料，包括干细胞和免疫细胞疗法。随着自然杀伤（NK）细胞，嵌合抗原受体T细胞（CAR-T细胞），抗原特异性T细胞，间充质干细胞/基质细胞等试验的早期结果，该领域只会继续扩大。随着血液研究领域科学家的减少，细胞治疗领域的成功至关重要的是集中精力培养新的研究人员，以及新的研究人员，也许考虑一个方向。新的研究人员以及可能接受过基于血液的研究基础培训的科学家可能缺乏将技术从实验室扩展到床边的经验。具体而言，他们可能没有用于处理血液和干细胞治疗的先进技术的经验，以及用于产品表征和治疗后患者评估的复杂测定。此外，大多数研究人员没有基于细胞的疗法的监管要求的经验，这是将潜在疗法从实验室转移到床边的明确挑战。在基于细胞的治疗的开发和临床实践中的综合教育计划将有助于对抗基于血液的研究人员的下降，并促进血液学和其他疾病治疗的进步。明尼苏达大学（UM）是提供这样一个项目的理想选择，在细胞疗法的发展方面有着良好的记录。UM的cGMP设施，分子和细胞治疗（MCT），作为NHLBI赞助合同的细胞治疗生产援助（PACT）集团的成员，已经非常成功。MCT一直是几个广受欢迎的PACT网络研讨会和设施研讨会以及与专业组织（例如，AABB和ISCT）[3]，并教育了来自世界各地的众多医学生，住院医生，研究员和访问学者。UM的生物保存核心资源（BioCoR）是国家唯一的保存资源，并在细胞疗法保存和细胞疗法保存技术和方法研究方面提供培训课程。这些资源和主机使UM非常适合提供这种短期的教育经验，以丰富血液学工作人员。 (End摘要）