Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of Mild to Moderate ED — PMD-MSC-ED-01  

Erectile Dysfunction Clinical Trial

Official title: Evaluate the Safety and Feasibility of Injecting Placental Matrix-Derived Mesenchymal Stem Cells Into the Penis to Treat the Symptoms of Mild to Moderate Erectile Dysfunction

Status Completed

Clinical Trial Summary

Prospective, open-label, non-randomized, study to be conducted at a single center. Ten subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) into the penis for the treatment of mild to moderate erectile dysfunction. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be evaluated for re-injection beginning at 3 months. Eligibility is determined by the clinician based on patient reported treatment satisfaction.

Clinical Trial Description

An estimated 18 million men in the United States are diagnosed with Erectile Dysfunction (ED). ED is a physical condition triggered by a man's mental, emotional, and medical state. Defined by the repeated and consistent problem sustaining an erection suitable for sexual intercourse; ED can lead to performance anxiety and depression as a result partners of men with ED also suffer emotional and psychological effects.

Lifestyle, smoking, medical conditions such as diabetes, hypertension and vascular problems, prostate cancer and medication side effects all can contribute to the cause of ED.

Conservative treatments can begin with lifestyle change; natural remedies include the use of herbs such as L-Arginine, Ginko, Zinc, and Yohimbe. Prescription medications known as phosphodiesterase type 5 inhibitors are often used but are costly. other therapies involve the penis pump/penis vacuum, penile implants that offer a permanent solution and surgery to improve the blood flow to the penis can improve erections.

Mesenchymal stem cells (MSCs) have been used for a variety of medical treatments to repair and regenerate acute and chronically damaged tissues. These cells have the potential to repair human tissue by forming cells of mesenchymal origin, such as cartilage, bone, fat, muscle, and blood vessels. Most research has focused on bone marrow derived stem cells (BMC) however the process for harvesting the cells is invasive, painful, and yields a low cell count. The human placenta offers an alternative source form MSCs. Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) are compromised of a novel cellular repair matrix derived from placental mesenchyme. Mesenchyme is the meshwork of embryonic connective tissue in the mesoderm, from which are formed the muscular and connective tissues of the body and also the blood vessels. PMD-MSCs provide the extracellular matrix viable mesenchymal stem cells (MSCs) that coordinate the tissue repair process, regenerative growth factors, and anti-inflammatory cytokines required to regenerate the damaged vasculature of the penile corpora.

Injecting PMD-MSCs into the penile corpora to replace the dysfunctional or dead cells is an intriguing option for cell-based treatment for ED. The research proposed here will establish the safety and feasibility of utilizing intracavernosal injections of PMD-MSCs to treat Erectile Dysfunction. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Erectile Dysfunction

• NCT number: NCT02398370
• Study type: Interventional
• Source: Z Urology
• Status: Completed
• Phase: Phase 1
• Start date: July 2013
• Completion date: March 2015