- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02107118
Stem Cells for the Improvement of Erectile and Cardiac Function in Aging Men
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 Overview
Status
Conditions
Intervention / Treatment
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
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- Baylor College of Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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 Names:
|
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.
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 months
|
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.
|
12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-34570 No.11-13-40-07
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Erectile Dysfunction
-
University of VirginiaActive, not recruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Erectile Dysfunction Due to General Medical Condition | Erectile Dysfunction Due to Arterial InsufficiencyUnited States
-
Cairo UniversityRecruitingErectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Simple Prostatectomy | Erectile Dysfunction With Diabetes Mellitus | Erectile Dysfunction Due to Arterial Disease | Erectile Dysfunction Due to Injury | Erectile Dysfunction Due to Neuropathy and other conditionsEgypt
-
University of BaghdadCompletedSexual Dysfunction | Erectile Dysfunction | Erectile Dysfunction Following Radical Prostatectomy | Erectile Dysfunction Following Radiation Therapy | Sexual Abstinence | Erectile Dysfunction With Diabetes Mellitus | Sexual Desire Disorder | Erectile Dysfunction Following Cryotherapy | Erectile Dysfunction... and other conditionsIraq
-
BayerCompletedSexual Dysfunction | Male Erectile DysfunctionBelgium, Italy, France, Germany, Spain, Netherlands, South Africa
-
Vancouver Coastal HealthRecruitingSituational Erectile DysfunctionCanada
-
University of VirginiaDIREX SYSTEMS CORPORATIONWithdrawnVasculogenic Erectile Dysfunction
-
Johns Hopkins UniversityTerminatedOrganic Erectile DysfunctionUnited States
-
University of MiamiDIREX SYSTEMS CORPORATIONCompletedVasculogenic Erectile DysfunctionUnited States
-
Cairo UniversityCompletedVasculogenic Erectile DysfunctionEgypt
-
InitiaTerminatedVasculogenic Erectile DysfunctionIsrael
Clinical Trials on ARM 1: AdMSC: adipose stem cells
-
Instituto de Investigación Hospital Universitario...UnknownRecto-vaginal FistulaSpain
-
Universidad Catolica Santiago de GuayaquilMaastricht University Medical CenterUnknownOsteo Arthritis KneeEcuador
-
Bioheart, Inc.Completed
-
Anterogen Co., Ltd.TerminatedPerianal Fistula | Primary; ComplexKorea, Republic of
-
Tower Outpatient Surgical CenterCompletedDiabetic Foot | Pressure Ulcer | Venous UlcerUnited States
-
Bioheart, Inc.WithdrawnChronic Obstructive Pulmonary DiseaseUnited States
-
Bioheart, Inc.WithdrawnDry Macular DegenerationUnited States
-
Martha Haahr M.DOdense University HospitalUnknownDelayed Graft FunctionDenmark
-
University of Science Ho Chi Minh CityVan Hanh General Hospital; Nguyen Tri Phuong Hospital, Ho Chi Minh city, Viet... and other collaboratorsUnknown
-
S.Biomedics Co., Ltd.Dt&SanomedicsActive, not recruitingCritical Limb IschemiaKorea, Republic of