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

Completed · Phase 1

Conditions studied: Erectile Dysfunction

In brief

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.

Key facts

Study ID

NCT02398370

Run by

Melissa Marchand

People needed

8

Starts

2013-07-01

Expected to finish

2015-03-01

Last updated by the study team

2015-04-27

Who can join

Age: 40 and older, up to 70. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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)
• 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

You may not qualify if…

• 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

Where it is running

• Z Urology — Coral Springs, Florida, United States

Full record on ClinicalTrials.gov

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