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.

项目总结