Polymer gel to treat TMJ pain

产品说明：该项目的目的是确定Crescent Innovations聚合物凝胶是否可用于治疗TMJ疼痛，700万美国人患有颞下颌关节疼痛（即，（图为Jaw Joint）。颞下颌关节疼痛的唯一长期非侵入性治疗是非甾体类抗炎药，它们的有效性不到50%。 该项目的总体目标是开发一种生物可吸收聚合物凝胶，可作为治疗与内紊乱和/或骨关节炎（ID/OA）相关的颞下颌关节疼痛的长期微创治疗。目前，NIH建议使用微创手术治疗TMJ疾病（TMD）。尽管如此，TMD患者或治疗他们的医生几乎没有微创治疗方法。 生物可吸收聚合物凝胶目前用于治疗膝关节骨关节炎。已经进行了一些工作，表明这些凝胶将为TMD患者提供益处，但工作有限。如果这种类型的产品是可用的，它将是唯一的长期微创疗法可用于TMD患者之一。 本阶段I SBIR应用的主要目的是确定使用专有Crescent Innovations聚合物凝胶治疗ID/OA TMD的可行性。这将导致一项II期研究，该研究将确定聚合物凝胶治疗的长期疗效和安全性影响。因此，本申请的具体目的是： 确定Crescent Innovations增强型配方（专门针对TM关节的独特特征）与用于治疗膝关节OA的产品相比，是否在动物模型中提供了上级临床受益。

DESCRIPTION: The purpose of this project is to determine if Crescent Innovations polymer gels have application in treating TMJ pain, 7 million Americans suffer pain in the temporomandibular joint (i.e., the jaw joint) each year. The only long term non-invasive therapy for TMJ pain is non-steroidal anti-inflammatories, and they are less than 50% effective. The overall objective of this program is to develop a biologically absorbable polymer gel that may serve as a long-term minimally invasive therapy for treating pain in the temporomandibular joint associated with internal derangement and/or osteoarthritis (ID/OA). Currently the NIH recommends that minimally invasive procedures be used to treat TMJ disorders (TMD). Despite this, there are few minimally invasive therapies available to TMD patients or the doctors who treat them. Biologically absorbable polymer gels are currently used to treat osteoarthritis of the knee. There has been some work performed that suggests these gels would provide a benefit to TMD patients, but the work is limited. If a product of this type were available, it would be one of the only long-term minimally invasive therapies available to TMD sufferers. The primary objective of this Phase I SBIR application is to determine the feasibility of using proprietary Crescent Innovations polymer gels to treat ID/OA TMD. This will lead to a Phase II study, which will determine the long-term efficacy and safety impact of the polymer gel treatment. Therefore, the Specific Aim of this Application is to: Determine if Crescent Innovations enhanced formulations, specifically catering to the unique characteristics of the TM joint, provide superior clinical benefits in an animal model compared to a product used to treat OA of the knee.