Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Erectile Dysfunction
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 30 years and 75 years
- Gender
- Only males
Description
Platelet-derived therapies are a growing trend across multiple medical and surgical specialties, mainly orthopedics for conditions such as bone and soft tissue trauma, inflammatory conditions, and chronic pain syndromes. One of the most well described platelet-based therapies is autologous platelet-...
Platelet-derived therapies are a growing trend across multiple medical and surgical specialties, mainly orthopedics for conditions such as bone and soft tissue trauma, inflammatory conditions, and chronic pain syndromes. One of the most well described platelet-based therapies is autologous platelet-rich plasma (PRP). This concentrate is then administered via injection. When platelets are activated, they release these growth differentiation factors, facilitating even nerve repair and regeneration. Growth factors act locally and are implicated in many aspects of natural wound healing, including chemotaxis, cell proliferation, cell differentiation and angiogenesis.The key role of platelets in these processes makes them an attractive candidate for therapies aimed at accelerating natural healing, as well as tissue regeneration. Although most of the studies focusing on PRP injections have been relatively small and heterogenous, they largely support the concept of administration in terms of safety, while efficacy remains uncertain. When platelets are activated, they release many kinds of growth differentiation factors and a few types have been found to facilitate nerve repair and regeneration. Moreover, corporeal dysfunction in ED due to smooth muscle atrophy or other intra-cavernosal pathology can lead to corporo-venous occlusive erectile dysfunction despite a normal arterial inflow. Rejuvenating the Corporeal tissues with PRP, which is well known for its growth and healing factors, is a possible modality as a potential treatment for erectile dysfunction according to Alkhayal et al. In their retrospective study examining the efficacy of one intra-cavernosal PRP injection to 40 ED patients, they reported that mean IIEF-5 score before treatment was 13 (5-20) and post treatment IIEF-5 = 17 (7-24), (p < 0.001). To date, there are no treatments that address the underlying cause of endothelial dysfunction, although LIST treatment for ED has shown promising results. Platelet-derived therapies targeting inflammation and promoting tissue/nerve regeneration and may represent a potential treatment option towards this direction.
Tracking Information
- NCT #
- NCT04396795
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Ranjith Ramasamy, MD University of Miami