Clinical Trial: Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:

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 repa
Sponsor: Melissa Marchand

Current Primary Outcome:

  • Peak Systolic Velocity without trimix (cm/s) [ Time Frame: Baseline ]
  • Peak Systolic Velocity without trimix (cm/s) [ Time Frame: 6 weeks ]
  • Peak Systolic Velocity without trimix (cm/s) [ Time Frame: 3 months ]
  • Peak Systolic Velocity without trimix (cm/s) [ Time Frame: 6 months ]
  • Peak Systolic Velocity without trimix (cm/s) [ Time Frame: 12 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • End Diastolic Velocity without trimix (cm/s) [ Time Frame: Baseline ]
  • End Diastolic Velocity without trimix (cm/s) [ Time Frame: 6 weeks ]
  • End Diastolic Velocity without trimix (cm/s) [ Time Frame: 3 months ]
  • End Diastolic Velocity without trimix (cm/s) [ Time Frame: 6 months ]
  • End Diastolic Velocity without trimix (cm/s) [ Time Frame: 12 months ]


Original Secondary Outcome: Same as current

Information By: Z Urology

Dates:
Date Received: March 9, 2015
Date Started: August 2013
Date Completion:
Last Updated: March 16, 2015
Last Verified: March 2015