drugset / Trial / NCT02107118
Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
RandomizedCrossoverSingle-blindTreatment
Summary
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.
Timeline
- Start
- 2015-05
- Primary completion
- 2020-03
- Completion
- 2022-02
Outcome
Outcome not reported
Stopped: “Contract issues”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AdMSC | Cell therapy | — | Other |