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

Study Overview
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Brief Summary
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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
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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.

Official Title
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H-34570: PHASE I Study: The Use of Autologous Adipose Tissue-Derived Mesenchymal Stem Cell (AdMSC) for the Improvement of Erectile and Cardiac Function in Aging Men

Conditions
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Erectile Dysfunction, Cardiac Disease

Intervention / Treatment
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* Biological: ARM 1: AdMSC: adipose stem cells
* Other: ARM 2: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ARM 1: AdMSC: adipose stem cells<br>AdMSC: Autologous adipose tissue-derived mesenchymal stem cell. Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. | Biological: ARM 1: AdMSC: adipose stem cells<br>* 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.<br>* Other names: ARM 1: AdMSC: Adipose derived mesenchymal stem cells;|
| Placebo Comparator: ARM 2 Placebo<br>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. | Other: ARM 2: Placebo<br>* 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.<br>* Other names: ARM 2 Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in IIEF scores of greater than 2 | 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvements in RHI (reactive hyperemic index) scores of greater than 0.3 | 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. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cells, cardiovascular disease, erectile dysfunction