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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Recruitment Status : Withdrawn (Contract issues)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

Tracking Information
First Submitted Date  ICMJE April 3, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date May 25, 2015
Study Start Date  ICMJE May 2015
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02107118 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 4, 2014)
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 4, 2014)
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Erectile Dysfunction
  • Cardiac Disease
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Biological: ARM 1: AdMSC: adipose 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.
    Intervention: Other: ARM 2: Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 22, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: April 4, 2014)
45
Estimated Study Completion Date  ICMJE February 2022
Estimated Primary Completion Date March 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02107118
Other Study ID Numbers  ICMJE H-34570 No.11-13-40-07
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohit Khera, Baylor College of Medicine
Study Sponsor  ICMJE Baylor College of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohit Khera, MD Baylor College of Medicine
PRS Account Baylor College of Medicine
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP