Magnetic Flow Sorter for Pancreatic Islet Isolation

用于胰岛分离的磁流分选机

• 批准号: 8589898
• 负责人: PAUL W TODD
• 金额: $ 91.6万
• 依托单位: TECHSHOT, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2016-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8589898
• 关键词: Allogenic; Allografting; Arizona; Autologous; Beta Cell; Blood Glucose; Businesses; Cardiovascular system; Cell Therapy; Centrifugation; Clinical; Clinical Research; Clinical Trials; Collaborations; Cyclic GMP; Device or Instrument Development; Devices; Diabetes prevention; Documentation; Effectiveness; Eligibility Determination; Engineering; Enrollment; Equilibrium; Evaluation; Evaluation Research; Family suidae; Funding; Goals; Housing; Human; Institutes; Insulin; Insulin-Dependent Diabetes Mellitus; International; Islets of Langerhans; Islets of Langerhans Transplantation; Label; Laboratories; Laboratory Research; Liver; Magnetism; Marketing; Methods; Morphology; Organ; Organ Donor; Outcome; Pancreas; Pancreatectomy; Patients; Performance; Phase; Phase III Clinical Trials; Physiology; Preparation; Procedures; Process; Production; Replacement Therapy; Research; Research Personnel; Safety; Sales; Sampling; Scientist; Series; Small Business Innovation Research Grant; Sorting - Cell Movement; Sterility; Technology; Testing; Therapeutic; Therapeutic Uses; Tissue Therapy; Tissues; Toxic effect; Translational Research; Translations; Transplant Recipients; Transplantation; United States; United States Food and Drug Administration; Universities; Work; Xenograft procedure; base; beta cell replacement; biomaterial compatibility; clinical practice; commercialization; cytotoxicity; design; gene therapy; improved; innovation; instrument; islet; islet stem cells; meetings; pre-clinical; prevent; programs; public health relevance; quality assurance; response; safety testing; skills; therapy development; tool; verification and validation

DESCRIPTION (provided by applicant): Techshot, Inc. has successfully completed SBIR Phase I and Phase II research demonstrating that magnetically labeled porcine islets of Langerhans can be isolated from contaminating exocrine tissue by flow sorting using a quadrupole magnetic separator ("Quadrasep") designed for that purpose. Magnetically sorted islets are superior in morphology and physiology to those isolated by the presently used centrifugation method. A Phase IIB Competing Renewal project is proposed in which Techshot will collaborate with scientists at the University of Arizona, University of Louisville, IKOTECH LLC and Vitacyte LLC to prepare this technology for regulatory approval and commercialization. A business plan is presented in which the target market is initially human isologous islet transplantation, a clinically approved and proven procedure. Subsequently allogeneic and xenogeneic transplantation are expected to follow as these markets mature along with increased use of magnetic flow separation. Objective: Techshot proposes translational research leading to the submission of a Device Master File (DMF) to the FDA supporting use of Quadrasep as a manufacturing tool for effecting the improved isolation of human pancreatic islets of Langerhans for therapeutic transplantation for the prevention of diabetes in pancreatectomy patients. Description: The project plan includes (1) Improving the existing successful quadrupole sorter technology to meet required commercial and regulatory standards including cGMP fabrication, (2) Proving the technology through a series of human islet purifications in direct comparison with current methods using widely accepted criteria for islet evaluation, and (3) Approving the technology through application for a Device Master File with the U. S. Food and Drug Administration. The outcome of the project is expected to include the development of an instrument and consumables kit that improves the quality of islet transplants for which there is increasing demand. These outcomes, in turn, represent improved opportunities to eventually cure type-1 diabetes, which is currently only managed.

描述（由申请人提供）：Techshot，Inc.已经成功完成SBIR第一阶段和第二阶段研究，证明磁性标记的猪胰岛可以通过使用为此目的设计的四极磁性分离器（“Quadrasep”）的流式分选从污染的外分泌组织中分离。磁性分选的胰岛在形态学和生理学上上级通过目前使用的离心方法分离的那些。提出了一个IIB阶段的竞争性更新项目，在该项目中，Techshot将与亚利桑那大学、路易斯维尔大学、IKOTECH LLC和Vitacyte LLC的科学家合作，为这项技术的监管批准和商业化做准备。提出了一个商业计划，其中目标市场最初是人类胰岛移植，临床批准和证明的程序。随后，随着这些市场的成熟沿着随着磁流分离的使用增加，预计同种异体和异种移植将随之而来。目的：Techshot提议进行转化研究，以向FDA提交器械主文件（DMF），支持使用Quadrasep作为制造工具，改善人类胰岛分离，用于治疗性移植，预防胰腺切除术患者的糖尿病。产品描述：该项目计划包括（1）改进现有成功的四极分选技术，以满足所需的商业和监管标准，包括cGMP制造，（2）通过一系列人胰岛纯化与目前使用广泛接受的胰岛评价标准的方法直接比较来证明该技术，以及（3）通过向美国申请器械主文件来批准该技术。S.食品药品监督管理总局.该项目的成果预计将包括开发一种仪器和耗材包，以提高需求日益增加的胰岛移植的质量。反过来，这些结果代表了最终治愈1型糖尿病的机会增加，目前只能管理。