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

Peyronie's Disease 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 Peyronie's Disease

Status Completed

Clinical Trial Summary

Prospective, open labeled, 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 Peyronie's Disease. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based on patient reported treatment satisfaction.

Clinical Trial Description

Symptoms of Peyronie's disease include penile pain and curvature of the penis that prevents penetration and/or causes erectile dysfunction (ED). It is characterized by plaques that form along the top or bottom side of the penis inside the tunica albuginea; the plaque begins as a localized inflammation then develops into a hardened scar. Cases can range from mild to severe. In several cases, the hardened plaque reduces flexibility, causing the penis to curve during erection. The sexual problems as a result can lower a man's self-esteem and interfere with a couple's physical and emotional relationship.

The cause is unknown; however, possibilities include trauma, inherited conditions, Vitamin E deficiency, diabetes, and vascular disease.

Conservative treatments used in the acute phase (initial onset of symptoms) include oral therapies. Vitamin E and antioxidants can decrease the build-up of harmful chemicals that can cause injury to tissue. It is often used as the traditional treatment; it is inexpensive and with proper dosing, there are minimal side effects. Other oral agents include Potaba (aminobenzoates potassium); however, it is expensive ($1000 per year) and has associated gastrointestinal side effects.

Other therapies involve injections directly in the plaques (intralesional) with chemicals such as collagenase or calcium-channel blockers.

Surgical therapies are offered once the disease is stable (symptoms present for one year). Invasive surgical options consist of correction of the penile curvature or the placement of a penile prosthesis to straighten the penis to allow for 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.

The research proposed here will establish the safety and feasibility of utilizing intracavernosal, intralesional injections of PMD-MSCs to treat Peyronie's disease with the intent of avoiding surgery. ;

Study Design

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

Related Conditions & MeSH terms

• Penile Induration
• Peyronie's Disease

• NCT number: NCT02395029
• Study type: Interventional
• Source: Z Urology
• Status: Completed
• Phase: Phase 1
• Start date: August 2013
• Completion date: March 2015