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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Biological: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 40-70 Willing and able to provide written informed consent Chronic, organic erectile dysfunction (ED), duration at least 0.5 years, with baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score greater than or equal to 21 Willing to complete questionnaires Involved in a monogamous, heterosexual relationship for at least 3 months with both partners motivated to have or attempt sexual intercourse at least 4 times per month beginning two weeks after study treatment (subject reported) Not interested or able to use oral PDE-5 inhibitor (PDE-5i) drug therapy, and willing to forgo these treatments for the first 6-month period following study treatment (in addition may include a 4-week washout since last PDE-5i use prior to completion of the baseline erectile function assessments and study treatment) Willing to limit alcohol intake and eliminate use of recreational drugs for sexual encounters Willing to undergo an injection 9 Mentally competent and able to understand all study requirements (based on investigator assessment) 10. Willing to be available for all baseline, treatment, and follow up examinations required by protocol 11. Willing to forego participation in any other study throughout the duration of this study Exclusion Criteria: Evidence of prostate cancer which requires additional radiotherapy or other adjuvant therapy Previous pelvic or abdominal radiation therapy Previous, concomitant or scheduled use of anti-androgen therapy Untreated hypogonadism or low serum total testosterone (<200 ng/dL) Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism Skin irritation, infection, wound, sore, or disruption in the immediate areas of skin entry for penile injection Use of any non-study treatment for erectile dysfunction within 4 weeks of study treatment and a lack of willingness to continue through 6 months after study treatment Any previous penile implant or penile vascular surgery Current or previous malignancy other than localized prostate cancer Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or <90 mm Hg, and diastolic blood pressure > 100 or < 50 mm Hg) Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening Current urinary tract or bladder infection Drug, alcohol, or substance abuse reported within the last three years (subject reported) Subject's sexual partner < 18 years of age or has any gynecologic problems Major medical conditions, or any other factors that would limit participation in sexual intercourse to less than 4 times per month (subject reported) Weight less than 154lbs/ 70 kg, or BMI greater than or equal to 30 Systemic autoimmune disorder Significant active systemic or localized infection Receiving immunosuppressant medications

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection of PMD-MSCs into the penis<br>Subjects will receive an initial injection of 1.0cc of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs). Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based patient reported treatment satisfaction. | Biological: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)<br> <br> * Other names: Ovation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Systolic Velocity without trimix (cm/s) |  | Baseline | 
| Peak Systolic Velocity without trimix (cm/s) |  | 6 weeks | 
| Peak Systolic Velocity without trimix (cm/s) |  | 3 months | 
| Peak Systolic Velocity without trimix (cm/s) |  | 6 months | 
| Peak Systolic Velocity without trimix (cm/s) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End Diastolic Velocity without trimix (cm/s) |  | Baseline | 
| End Diastolic Velocity without trimix (cm/s) |  | 6 weeks | 
| End Diastolic Velocity without trimix (cm/s) |  | 3 months | 
| End Diastolic Velocity without trimix (cm/s) |  | 6 months | 
| End Diastolic Velocity without trimix (cm/s) |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ED