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

Completed · Phase 1

Conditions studied: Peyronie's Disease

In brief

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.

Key facts

Study ID

NCT02395029

Run by

Melissa Marchand

People needed

5

Starts

2013-08-01

Expected to finish

2015-03-01

Last updated by the study team

2015-03-20

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
• 1 or 2 penile plaque at screening

You may not qualify if…

• taking the medication Coumadin
• unable to achieve adequate erection with penile injection to access degree of curvature
• undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
• prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorder including major depression, schizophrenia, bipolar disease
• history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
• clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
• received any other investigational drug within 30 days

Where it is running

• Z Urology — Coral Springs, Florida, United States

Full record on ClinicalTrials.gov

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