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

Baylor College of Medicine

Status and phase: Withdrawn; Phase 1

Conditions: Erectile Dysfunction; Cardiac Disease

Treatments: Biological: ARM 1: AdMSC: adipose stem cells; Other: ARM 2: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02107118

H-34570 No.11-13-40-07

Details and patient eligibility

About

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.

Full 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.

Sex: Male

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 2 patient groups, including a placebo group

ARM 1: AdMSC: adipose stem cells

Active Comparator group

Description:

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.

Treatment:

Biological: ARM 1: AdMSC: adipose stem cells

ARM 2 Placebo

Placebo Comparator group

Description:

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.

Treatment:

Other: ARM 2: Placebo