STTR Phase I: Non-invasive focused ultrasound treatment to modulate the immune system for acute and chronic kidney rejection

STTR 第一期：非侵入性聚焦超声治疗调节免疫系统以治疗急性和慢性肾排斥

• 批准号: 2312694
• 负责人: Shen Ning
• 金额: $ 27.5万
• 依托单位: INIA BIOSCIENCES, INC.
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2024
• 资助国家: 美国
• 起止时间: 2024-03-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=2312694&HistoricalAwards=false
• 关键词: STTR; Phase; Non; invasive; focused

The broader impact/commercial potential of this Small Business Technology Transfer (STTR) Phase I project is a novel medical device therapy for improving the clinical outcomes of patients receiving organ transplants. Over 100,000 kidney transplant procedures are performed worldwide each year, with up to 20% of patients experiencing rejection. Existing drug treatments, including immunosuppressants, often entail significant side effects with a high financial cost of nearly $30,000 per year per patient. This project aims to develop an external system for reducing inflammatory responses thereby reducing adverse events associated with the transplant and extending the lifetime of the new organ. Beyond kidney organ transplantation, the technology provides potential extensibility for other organ transplants as well as addressing various chronic inflammatory diseases. This Small Business Technology Transfer (STTR) Phase I project aims to develop a novel ultrasound-based medical device therapy for reducing post-transplant organ rejection. The external system stimulates targeted nerves in the spleen to modulate the immune system through established physiologic pathways. The proposal aims to optimize various ultrasonic parameters in a transplant model to further development towards a functional prototype. The key objectives include 1) developing a pre-clinical transducer delivering the desired therapeutic ultrasonic waveform to the targeted splenic nerves, 2) optimizing the treatment parameters using an accepted preclinical skin allograft model, and 3) validating the reduction in pro-inflammatory cytokines in situ in accepted preclinical models. The results of this proposal will demonstrate the safety and feasibility of this technological approach toward eventual clinical patient translation.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.

该小企业技术转让（STTR）I期项目的更广泛影响/商业潜力是一种新型医疗器械疗法，用于改善接受器官移植患者的临床结局。全世界每年进行超过100，000例肾移植手术，其中高达20%的患者发生排斥反应。现有的药物治疗，包括免疫抑制剂，往往会产生严重的副作用，每位患者每年的经济成本接近30，000美元。该项目旨在开发一种用于减少炎症反应的外部系统，从而减少与移植相关的不良事件并延长新器官的寿命。除了肾脏器官移植，该技术还为其他器官移植提供了潜在的可扩展性，并解决了各种慢性炎症性疾病。 这个小企业技术转让（STTR）第一阶段项目旨在开发一种新型的基于超声的医疗设备疗法，以减少移植后器官排斥反应。外部系统刺激脾脏中的靶向神经，以通过已建立的生理途径调节免疫系统。该提案旨在优化移植模型中的各种超声参数，以进一步开发功能原型。主要目标包括：1）开发一种临床前换能器，将所需的治疗超声波波形输送到目标脾神经; 2）使用公认的临床前皮肤同种异体移植模型优化治疗参数; 3）在公认的临床前模型中原位验证促炎细胞因子的减少。该提案的结果将证明这种技术方法的安全性和可行性，以最终临床患者translation.This奖项反映了NSF的法定使命，并已被认为是值得通过使用基金会的智力价值和更广泛的影响审查标准进行评估的支持。