Clinical trial NCT02107118: Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Erectile Dysfunction
Cardiac Disease
Keywords: Stem cells
cardiovascular disease
erectile dysfunction
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2014-04-08
Enrollment: 0
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Improvements in IIEF scores of greater than 2
timeFrame: 12 months
Secondary outcomes:
measure: Improvements in RHI (reactive hyperemic index) scores of greater than 0.3
timeFrame: 12 months
Other outcomes:
measure: Improvements in penile duplex
timeFrame: 12 months
measure: Improvements in echocardiogram
timeFrame: 12 months
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Mohit Khera, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khera M, Albersen M, Mulhall JP. Mesenchymal stem cell therapy for the treatment of erectile dysfunction. J Sex Med. 2015 May;12(5):1105-6. doi: 10.1111/jsm.12871. No abstract available.