Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Primary Purpose
Erectile Dysfunction, Cardiac Disease
Status
Withdrawn
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ARM 1: AdMSC: adipose stem cells
ARM 2: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Erectile Dysfunction focused on measuring Stem cells, cardiovascular disease, erectile dysfunction
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)
Sites / Locations
- Baylor College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
ARM 1: AdMSC: adipose stem cells
ARM 2 Placebo
Arm 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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02107118
Brief Title
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
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Contract issues
Study Start Date
May 2015 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
February 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erectile Dysfunction, Cardiac Disease
Keywords
Stem cells, cardiovascular disease, erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ARM 1: AdMSC: adipose stem cells
Arm Type
Active Comparator
Arm 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.
Arm Title
ARM 2 Placebo
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
ARM 1: AdMSC: adipose stem cells
Other Intervention Name(s)
ARM 1: AdMSC: Adipose derived mesenchymal stem cells
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ARM 2: Placebo
Other Intervention Name(s)
ARM 2 Placebo
Intervention 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.
Primary Outcome Measure Information:
Title
Improvements in IIEF scores of greater than 2
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvements in RHI (reactive hyperemic index) scores of greater than 0.3
Description
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.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Improvements in penile duplex
Description
The analysis will allow us to assess if stem cells can improve penile duplex. The penile duplex will be given at the 3 and 12 month visits.
Time Frame
12 months
Title
Improvements in echocardiogram
Description
The analysis will allow us to assess if stem cells can improvement results of the echocardiogram. The echocardiogram will be done at the 3 and 12 month visits.
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohit Khera, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
25974235
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.
Results Reference
derived
Learn more about this trial
Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
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