NCT02107118

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2015

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 3, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2014

Completed
1.1 years until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

May 25, 2015

Status Verified

May 1, 2015

Enrollment Period

4.8 years

First QC Date

April 3, 2014

Last Update Submit

May 22, 2015

Conditions

Erectile DysfunctionCardiac Disease

Keywords

Stem cellscardiovascular diseaseerectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

  • Improvements in RHI (reactive hyperemic index) scores of greater than 0.3

    12 months

Other Outcomes (2)

  • Improvements in penile duplex

    12 months

  • Improvements in echocardiogram

    12 months

Study Arms (2)

ARM 1: AdMSC: adipose stem cells

ACTIVE COMPARATOR

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

ARM 2 Placebo

PLACEBO COMPARATOR

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

Interventions

ARM 1: AdMSC: adipose stem cellsBIOLOGICAL

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.

Also known as: ARM 1: AdMSC: Adipose derived mesenchymal stem cells
ARM 1: AdMSC: adipose stem cells
ARM 2: PlaceboOTHER

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.

Also known as: ARM 2 Placebo
ARM 2 Placebo

Eligibility Criteria

Age40 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 25974235DERIVED

MeSH Terms

Conditions

Erectile DysfunctionHeart DiseasesCardiovascular Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesSexual Dysfunction, PhysiologicalMale Urogenital DiseasesSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Mohit Khera, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 8, 2014

Study Start

May 1, 2015

Primary Completion

March 1, 2020

Study Completion

February 1, 2022

Last Updated

May 25, 2015

Record last verified: 2015-05

Locations

US(1)