Disease Modifying Treatment Using Combined Shockwave Therapy and Platelet Rich Plasma In Microvascular Erectile Dysfunction

使用组合冲击波疗法和富血小板血浆治疗微血管勃起功能障碍的疾病修饰治疗

• 批准号: 10490478
• 负责人: Ranjith Ramasamy
• 金额: $ 30.7万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-21 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10490478
• 关键词: Adoption; Adverse effects; Affect; Aftercare; Age; Alpha Granule; Alternative Therapies; Angiogenic Factor; Biological; Blood Platelets; Blood Vessels; Clinical; Clinical Research; Clinical Trials; Colony-forming units; Combined Modality Therapy; Conduct Clinical Trials; Data; Devices; Diabetes Mellitus; Disease; Dose; Double-Blind Method; Drops; Endothelium; Erectile dysfunction; Exclusion Criteria; Foundations; Functional disorder; Future; Goals; Growth Factor; Human; Hypertension; Injections; Institutional Review Boards; International; Intervention; Measures; Mediating; Metabolic syndrome; Microvascular Dysfunction; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Painless; Pathology; Patient Selection; Patient-Focused Outcomes; Peripheral Vascular Diseases; Placebos; Plasma; Predictive Value; Prevention; Publishing; Randomized; Research Design; Resistance; Safety; Sample Size; Serum; Shock; Structure; Techniques; Testing; Therapeutic; United States; Vascular Endothelial Growth Factors; Vascular System; Vasodilation; Western World; aging population; arm; cytokine; effective therapy; endothelial dysfunction; endothelial stem cell; erection; hemodynamics; improved; improved functioning; indexing; inhibitor; men; novel; novel therapeutic intervention; novel therapeutics; open label; penis; peripheral blood; phosphodiesterase V; primary outcome; randomized placebo controlled trial; randomized trial; recruit; reparative capacity; response; safety and feasibility; safety study; secondary outcome; success; symptomatic improvement; tissue regeneration; treatment strategy

Project Summary Microvascular erectile dysfunction associated with hypertension and diabetes is becoming increasingly common in an aging population of the Western world. Despite several effective treatments available for ED, no disease modifying intervention capable of improving the underlying pathophysiology of ED and restoring erectile function is available. Shock wave therapy (SWT) is a novel, painless, non-invasive experimental strategy which elicits biological responses in the vascular system, including stimulation of endogenous reparative capacity and formation of new blood vessels. Platelet-rich plasma (PRP) is an alternative therapy to promote tissue regeneration mediated by the release of several growth factors and cytokines stored in the alpha granules of platelets. Although SWT and PRP has been investigated for ED in clinical trials as monotherapy, the combination has not been investigated. We have shown the safety of using SWT over a short duration for men with ED in a randomized superiority trial. We also have shown safety of PRP in an ongoing clinical trial. We believe that the action of SWT and PRP is additive. The working hypothesis underlying this proposal is that SWT and PRP will be additive for ED and improve subjective erective function scores, objective penile hemodynamics and promote penile endothelial function. We will conduct a single center open label trial with 30 men with mild to moderate ED who will receive two intracavernous injections of PRP (6 weeks apart) with weekly SWT in between. We will evaluate improvement in ED using International Index of Erectile Function score at 3 and 6 months (Aim1). We will determine the mechanism by which penile SWT + PRP improves microvascular ED (Aim 2) by evaluating penile vascular flow and endothelial function. SWT + PRP is a promising, cutting edge technique, which will likely contribute significantly towards management of ED. The proposed study is a pilot and feasibility clinical trial conducted in humans that will acquire preliminary data, collect feasibility data related to recruitment and retention, and lay the foundation for a larger clinical trial related to the prevention and/or treatment of ED, a disease within the mission of NIDDK.

项目摘要 与高血压和糖尿病相关的微血管勃起功能障碍正变得越来越常见 在老龄化的西方世界。尽管有几种有效的治疗艾德，没有疾病 能够改善艾德的潜在病理生理学并恢复勃起功能的改良干预 服务器租用-美国服务租用冲击波治疗是一种新型、无痛、无创的实验治疗方法， 血管系统中的生物反应，包括刺激内源性修复能力， 形成新的血管。富血小板血浆（PRP）是促进组织 再生由储存在细胞α颗粒中的几种生长因子和细胞因子的释放介导， 血小板尽管SWT和PRP在临床试验中作为单一疗法被研究用于艾德， 尚未被调查。我们已经证明了短期使用SWT治疗男性艾德的安全性， 随机优效性试验。我们还在一项正在进行的临床试验中证明了PRP的安全性。我们认为 SWT和PRP的作用是相加的。这项建议的工作假设是，SWT和PRP将 对艾德有辅助作用，改善主观勃起功能评分，客观阴茎血流动力学，促进 阴茎内皮功能我们将进行一项单中心开放标签试验，有30名轻度至中度 艾德患者将接受两次PRP海绵体内注射（间隔6周），其间每周接受一次SWT。我们将 在3个月和6个月时使用国际勃起功能指数评分评价艾德的改善（Aim 1）。我们 将通过评估阴茎SWT + PRP改善微血管艾德（目标2）的机制， 阴茎血管血流和内皮功能。SWT + PRP是一种很有前途的尖端技术， 可能对ED的管理做出重大贡献。拟议的研究是一项试点和可行性临床研究。 在人体中进行的试验，将获得初步数据，收集与招募相关的可行性数据， 保留，并为预防和/或治疗艾德相关的大型临床试验奠定基础， NIDDK的使命中的疾病。