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

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.

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)