Cardiac Disease, Erectile Dysfunction
Conditions
Keywords
Stem cells, cardiovascular disease, erectile dysfunction
Brief 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.
Detailed description
Baseline assessment of patients will include completion of 6 questionnaires, EKG (electrocardiogram), vision testing using a standard eye chart, markers of endothelial dysfunction hormone evaluation, laboratory blood tests, vital signs, penile ultrasound (optional), echocardiogram, chest x-ray, and endothelial function assessment (Endopat). The adipose tissue sample is sent to Celltex's state-of-the-art laboratory in Houston, Texas. For those subjects 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. The subject (patient) will receive an infusion of either autologous stem cells (cells made from his own fat tissue) or placebo every 2 weeks for 3 months. Placebo will be in the form of normal saline. Subjects will be closely monitored every two weeks for first 3 months and once the treatment is complete, subjects will be monitored every 3 months for the first year. Each of the previously mentioned tests will be performed at the 3, 6, 9, and 12 month mark. However, the penile ultrasound (optional) and the echocardiogram will be performed only at the 3 and 12 month mark.
Interventions
BIOLOGICALARM 1: AdMSC: adipose stem cells
Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. Cells are returned to the study doctor for installation into the subject every 2 weeks for 3 months.
OTHERARM 2: Placebo
Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. For those subjects 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.
Sponsors
Baylor College of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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)
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in IIEF scores of greater than 2 | 12 months | The analysis will allow us to assess if stem cells can improve IIEF scores. The IIEF will be given at the 3, 6, 9, and 12 month visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvements in RHI (reactive hyperemic index) scores of greater than 0.3 | 12 months | The analysis will allow us to assess if stem cells can improve endothelial function. The RHI scores will be reviewed at the 3, 6, 9, and 12 month visits. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Improvements in penile duplex | 12 months | The analysis will allow us to assess if stem cells can improve penile duplex. The penile duplex will be given at the 3 and 12 month visits. |
| Improvements in echocardiogram | 12 months | The analysis will allow us to assess if stem cells can improvement results of the echocardiogram. The echocardiogram will be done at the 3 and 12 month visits. |
Countries
United States
Outcome results
None listed