SBIR Phase I: Arthroscopy Delivered Scaffolds to Repair and Regenerate Meniscus for Aging Patients

SBIR 第一阶段：关节镜为老年患者修复和再生半月板提供支架

• 批准号: 1648039
• 负责人: James Yongxing Liu
• 金额: $ 22.5万
• 依托单位: Innovative Elements, LLC
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-12-15 至 2018-07-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1648039&HistoricalAwards=false
• 关键词: SBIR; Phase; Arthroscopy; Delivered; Scaffolds

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is to prevent or reduce the high risk of post-meniscectomy osteoarthritis (OA) following partial meniscectomy which is a popular treatment for meniscus tears. Meniscus tears represent common lesions injuries prevailing in ~36% of people with ages at and greater than 45 years old, but with few effective treatments. Meniscectomy is performed to temporarily relieve the severe pain and other symptoms associated with meniscus tears. Over one million patients undergo meniscectomy to palliate painful symptoms associating torn meniscus each year in the U.S. The drawback of meniscectomy is significant increases of incidence of osteoarthritis (OA) later in life (by as high as 7 folds), because loss of meniscus causes altered load transmission, decreased shock absorption, and decreased joint stability and increased joint cartilage contact stress. Post-meniscectomy osteoarthritis (OA) is well documented in literatures. OA is more challenging to treat and incur more costly expenditures and causes more severe physical sufferings for patients. There is urgent need for effective treatment for meniscus tears while reducing or preventing the poste-meniscectomy risks. The proposed project could, if successful, potentially address the unmet clinical need by developing a device precisely repairing and regenerating the torn meniscus and restoring the biomechanical functionality. No existing knowledge teaches how an aging joint environment may affect the meniscal repair and regeneration, and neither the applicants? previous study can tell how their new device may perform in the aging joints; both scientific evidence and necessary technical solutions are unclear yet. The present Phase I study will: 1) determine the delivery strategy to stimulate reparative stem cells in aging knees, and 2) determine the delivery strategy under additional inflammatory stress, using in vitro evaluation models. The study serves as a critical step of proof-of-concept for future translation of the technology into a clinical application.

这个小型企业创新研究(SBIR)第一阶段项目的更广泛的影响/商业潜力是预防或降低半月板切除后骨关节炎(OA)的高风险，部分半月板切除是治疗半月板撕裂的一种流行方法。半月板撕裂是常见的皮损损伤，约36%的年龄在45岁及以上的人中流行，但很少有有效的治疗方法。半月板切除术是为了暂时缓解与半月板撕裂相关的剧烈疼痛和其他症状。在美国，每年有100多万患者接受半月板切除术，以缓解与半月板撕裂相关的疼痛症状。半月板切除术的缺点是，半月板切除术显著增加了晚年骨关节炎(OA)的发生率(高达7倍)，因为半月板的丧失会导致载荷传递改变，减震能力降低，关节稳定性降低，关节软骨接触应力增加。半月板切除术后的骨性关节炎(OA)在文献中有很好的记载。骨性关节炎的治疗更具挑战性，费用更高，给患者带来更严重的身体痛苦。在减少或预防半月板切除术后风险的同时，迫切需要对半月板撕裂进行有效的治疗。拟议的项目如果成功，可能会通过开发一种精确修复和再生撕裂的半月板并恢复生物力学功能的设备来解决未得到满足的临床需求。没有现有的知识教授老化的关节环境如何影响半月板的修复和再生，申请者也没有吗？之前的研究可以告诉我们，他们的新设备在老化的关节中可能会有怎样的表现；科学证据和必要的技术解决方案都尚不清楚。目前的第一阶段研究将：1)确定刺激老化膝关节修复干细胞的给药策略，2)使用体外评估模型，确定在额外炎症应激下的给药策略。这项研究是未来将该技术转化为临床应用的概念验证的关键一步。