Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of … (NCT02398370) | Clinical Trial Compass
CompletedPhase 1
Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of Mild to Moderate ED
United States8 participantsStarted 2013-07
Plain-language 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.
Who can participate
Age range40 Years – 70 Years
SexMALE
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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)
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