drugset / Trial / NCT02107118

Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men

NCT02107118 ↗

Phase 1 Withdrawn Baylor College of Medicine
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

EvaluationDrugModalityDoseRoute
Comparator AdMSC Cell therapy — Other