Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Withdrawn before enrolling · Phase 1 · Has a placebo group
Conditions studied: Erectile Dysfunction, Cardiac Disease
In brief
Men who present with erectile dysfunction as defined as an IIEF (International Index of Erectile Function) score less than 21 will be evaluated for risk factors for cardiovascular disease (CVD). This is a single-blind study. Subjects will be randomized in a 2:1 fashion for treatment (ARM 1) versus placebo (ARM 2). Adipose tissue (fat) will be harvested from all patients and stem cells will be cultured. For those patients in the placebo arm the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm.
Key facts
- Study ID
- NCT02107118
- Run by
- Baylor College of Medicine
- People needed
- 0
- Starts
- 2015-05-01
- Expected to finish
- 2022-02-01
- Last updated by the study team
- 2015-05-25
Who can join
Age: 40 and older. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Men 40 years of age or older
- Men with erectile dysfunction as defined by IIEF score less than 21
- Men with endothelial dysfunction as defined as an RHI score less than 2
- Men with normal testosterone levels (300 ng/dl)
You may not qualify if…
- Men under the age of 40
- Men with normal erectile function
- Men with normal endothelial function
- Men with low testosterone levels (less than 300ng/dl)
Where it is running
- Baylor College of Medicine — Houston, Texas, United States
Full record on ClinicalTrials.gov
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