Autologous Bone Marrow Cells in Treatment of Erectile Dysfunction.

Erectile dysfunction (ED) is characterized by abnormalities of the vascular system; most
commonly, venous leakage (or veno-occlusive dysfunction) resulting from loss of integrity of
the surrounding corporal smooth muscle. In the penile vascular system, the corporal smooth
muscle is responsible for trapping the blood delivered to the corpora cavernosa via the
arterial system. In men who develop ED at an early age, loss of smooth muscle mass, rather
than arterial dysfunction, is believed to be the major culprit in the inability to maintain
or sustain erections.

Bone marrow is enriched for cells with regenerative potential, including mesenchymal stem
cells, which accelerate healing of damaged tissue. The possibility of using bone marrow cells
in the treatment of ED is enticing since stem/progenitor cell populations are known to
secrete various growth factors, possess anti-inflammatory activities, and can differentiate
into cells of the penile architecture.

This study will evaluate safety and efficacy of autologous bone marrow mononuclear cells
concentrated by a closed system device and injected intra-cavernously in 20 patients aged 18
to 40 years of age diagnosed with erectile dysfunction with low dose 30 cc or high dose 60
cc. Safety and efficacy will be evaluated at baseline (prior to treatment) and at 1,3,6 and
12-month follow up visits. The study will determine whether injection of bone marrow cells
intra-cavernously is a clinically feasible, safe and reproducible approach for treating
erectile dysfunction.

Inclusion Criteria:

1. Chronic organic ED duration at least 0.5 years

2. Diagnosis of ED based on Doppler Ultrasound and/or dynamic infusion cavernosonometry.

3. Baseline International Index of Erectile Function (IIEF) score of < 26

4. Oral medications and intracavernous pharmacological approaches have been deemed
ineffective, contraindicated or cannot be tolerated.

5. Concurrently undergoing treatment with testosterone.

6. Willing to forego any other treatments for ED over the course of the study.

Exclusion Criteria:

1. Subjects using any medications/drugs with known effects on erectile function within 4
weeks of the study period, including certain antidepressants, antihistamines,
diuretics, and beta-blockers.

2. Subjects using herbal remedies for addressing erectile dysfunction within one month of
study initiation.

3. Subjects with penile prosthesis or other urinary prosthesis.

4. Subjects with penile anatomical deformities (e.g. Peyronie's disease) or history of
priapism.

5. Previous penile surgeries for erectile dysfunction, premature ejaculation or penile
enlargement.

6. Diagnosis of psychogenic ED as determined by nocturnal tumenscence testing.

7. Presenting with uncontrolled or severe disease, including cardiovascular disease,
diabetes, liver disease.

8. Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg,
and diastolic blood pressure > 100 or < 50 mm Hg)

9. Suffered a cardiovascular event within 6 months prior to study initiation.

10. Current or previous malignancy other than non-melanoma skin cancer (successfully
treated or treatable by curative excision or other local curative therapy).

11. Diagnosis of a systemic autoimmune disorder.

12. Receiving immunosuppressant medications.