Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of Mild to Moderate ED
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

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.
    

Detailed 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.
    

Intervention name(s): Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
Intervention type(s): Biological
Other intervention name(s): Ovation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ED