CELLULAR PROCESSING CORE

蜂窝处理核心

• 批准号: 7690367
• 负责人: IAN K MCNIECE
• 金额: $ 26.82万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7690367
• 关键词: Aerobic; Basic Science; Bathing; Cardiac; Cell physiology; Cells; Clinical; Clinical Research; Clinical Trials; Collaborations; Condition; Conduct Clinical Trials; Development; Endotoxins; Enrollment; Ensure; Exclusion; Freezing; Growth Factor; Guanosine Monophosphate; Human Resources; Infusion procedures; Institutes; Investigational Drugs; Investigational New Drug Application; Laboratories; Mesenchymal Stem Cells; Notification; Patients; Phase; Plasmalyte A; Procedures; Process; Rate; Reagent; Research Infrastructure; Research Personnel; Sampling; Services; Standards of Weights and Measures; Stem cells; Sterility; Telefacsimile; Testing; Time; Tissues; Translations; Trypan Blue; Validation; Water; Work; method development; pre-clinical; preclinical study; reagent testing; research study; scale up

Cellular Processing Core (CPC) The CPC has been established to provide the rapid and safe transition of basic research ideas to clinical practice. Some of the preclinical tasks include the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, the provision of a controlled good tissue practice GTP infrastructure and support for compiling investigational New Drug (IND) applications. The CPC will support Projects 1 and 3 in the translation of the research studies proposed in these projects to clinical trials. This is a rate limiting step at many Institutes and by centralizing this function in the Core; these studies will undergo pre clinical development and scale up in an optimal fashion. The personnel in the CPC will assist the PIs of Projects 1 and 3 in submitting an IND to conduct the clinical trials, will provide QA/QC assistance and will generate SOPs and worksheets to ensure compliance with regulatory agents in the conduct of the clinical studies.

细胞加工核心（CPC）已建立CPC，以便将基础研究思想的快速安全过渡到临床实践。一些临床前任务包括试剂的资格和测试，方法扩大，标准操作程序的开发（SOP），正在进行的过程验证，提供受控良好的组织实践GTP基础结构以及支持调查研究新药（IND DRIGS）的支持（IND） 申请。 CPC将在这些项目中提出的研究研究中的研究中支持项目1和3。这是许多机构的速率限制步骤，并通过将此功能集中在核心中。这些研究将进行临床前开发并以最佳方式扩展。 CPC中的人员将协助项目1和3的PI提交IND进行临床试验，将提供质量保证/QC援助，并将生成SOP和工作表，以确保对临床研究的监管机构遵守。