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)

 描述（由适用提供）：干细胞疗法市场的价值为27亿美元，目前主要由造血干细胞（HSC）移植市场组成。 HSC疗法的增长率约为10.6％，干细胞疗法的进步正在扩大，超出血液病恶性肿瘤的治疗方法，以治疗心血管，神经系统疾病和其他疾病。血液产品为制造几种新型细胞疗法（包括干细胞和免疫细胞疗法）提供了原材料。随着天然杀伤（NK）细胞的试验，嵌合antgen受体T细胞（CAR-T细胞），抗原特异性T细胞，间质干/基质细胞等进行了试验，该领域只会继续扩展。随着基于血液的研究的科学家的下降，对于细胞疗法领域的成功至关重要，将精力集中在培训CRRENT研究人员以及新的研究人员上，可能会考虑一个方向。在基于血液的研究基础上接受培训的新研究人员以及科学家可能缺乏从长凳到床边扩大技术的经验。具体而言，他们可能没有用于处理基于血液和干细胞疗法的先进技术的经验，以及用于产品表征和治疗后患者评估的复杂测定法。此外，大多数研究人员没有对基于细胞的疗法的调节要求的经验，这是将潜在疗法从长凳转移到床边的明确挑战。在基于细胞的疗法的开发和临床实践中，一项综合教育计划将有助于抵消基于血液的研究者的下降并促进血液学和其他疾病的治疗方面的进步。明尼苏达大学（UM）的理想位置可以提供这样的计划，并具有良好的细胞疗法发展记录。 UM，分子和细胞疗法（MCT）的CGMP设施已成为NHLBI赞助的合同的蜂窝疗法（PACT）组的生产辅助成员。 MCT一直是与专业组织（例如AABB和ISCT）[3]的几个受到良好公约网络研讨会和设施研讨会和教育计划的组成部分[3]，并且已经教育了来自世界各地的众多医学生，居民，研究员和访问学者。 UM的生物保存核心资源（Biocor）仅是国家准备的资源，并提供了培训课程，以制备细胞疗法以及对细胞疗法的技术和保存方法的研究。这些资源和主人使UM非常适合提供这种短期教育经验，以丰富血液学劳动力。 （抽象的结尾）