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

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ClinicalTrials.gov Identifier: NCT02107118
Recruitment Status : Withdrawn (Contract issues)
First Posted : April 8, 2014
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):
Mohit Khera, Baylor College of Medicine

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.

Condition or disease Intervention/treatment Phase
Erectile Dysfunction Cardiac Disease Biological: ARM 1: AdMSC: adipose stem cells Other: ARM 2: Placebo Phase 1

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : May 2015
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : February 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: ARM 1: AdMSC: adipose stem cells
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
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.
Other Name: ARM 1: AdMSC: Adipose derived mesenchymal stem cells

Placebo Comparator: ARM 2 Placebo
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
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 Name: ARM 2 Placebo




Primary Outcome Measures :
  1. Improvements in IIEF scores of greater than 2 [ Time Frame: 12 months ]
    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 :
  1. Improvements in RHI (reactive hyperemic index) scores of greater than 0.3 [ Time Frame: 12 months ]
    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.


Other Outcome Measures:
  1. Improvements in penile duplex [ Time Frame: 12 months ]
    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.

  2. Improvements in echocardiogram [ Time Frame: 12 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02107118


Locations
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United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Investigators
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Principal Investigator: Mohit Khera, MD Baylor College of Medicine

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohit Khera, Associate Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02107118     History of Changes
Other Study ID Numbers: H-34570 No.11-13-40-07
First Posted: April 8, 2014    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: May 2015

Keywords provided by Mohit Khera, Baylor College of Medicine:
Stem cells
cardiovascular disease
erectile dysfunction

Additional relevant MeSH terms:
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Erectile Dysfunction
Heart Diseases
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Cardiovascular Diseases