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: 10342876
• 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/10342876
• 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/antagonist; 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.

项目概要 与高血压和糖尿病相关的微血管勃起功能障碍变得越来越普遍 在西方世界人口老龄化的背景下。尽管有几种有效的治疗 ED 的方法，但没有疾病 修改干预措施能够改善 ED 的潜在病理生理学并恢复勃起功能 可用。冲击波疗法 (SWT) 是一种新颖、无痛、非侵入性的实验策略，可引发 血管系统的生物反应，包括刺激内源性修复能力和 新血管的形成。富含血小板血浆（PRP）是促进组织生长的替代疗法 通过释放储存在α颗粒中的几种生长因子和细胞因子介导的再生 血小板。尽管 SWT 和 PRP 已在临床试验中作为单一疗法对 ED 进行了研究，但联合用药 尚未被调查。我们已经证明，对于患有 ED 的男性来说，短期使用 SWT 是安全的。 随机优势试验。我们还在正在进行的临床试验中证明了 PRP 的安全性。我们相信 SWT 和 PRP 的作用是相加的。该提案的工作假设是 SWT 和 PRP 将 补充 ED 并改善主观勃起功能评分、客观阴茎血流动力学并促进 阴茎内皮功能。我们将对 30 名患有轻度至中度症状的男性进行单中心开放标签试验 急诊科将接受两次 PRP 海绵体内注射（间隔 6 周），中间每周进行 SWT。我们将 使用 3 个月和 6 个月时的国际勃起功能指数评分评估 ED 的改善情况（目标 1）。我们 将通过评估确定阴茎 SWT + PRP 改善微血管 ED 的机制（目标 2） 阴茎血管流量和内皮功能。 SWT + PRP 是一种有前景的尖端技术，它将 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，收集与招募和相关的可行性数据 保留，并为与预防和/或治疗 ED 相关的更大规模的临床试验奠定基础， NIDDK 使命范围内的疾病。