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

NCT ID: NCT02107118

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2022-02-28

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.

Conditions

Erectile Dysfunction; Cardiac Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

ARM 1: AdMSC: adipose stem cells

Intervention Type: BIOLOGICAL

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.

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.

Group Type: PLACEBO_COMPARATOR

ARM 2: Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: BIOLOGICAL

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 Type: OTHER

Other Intervention Names

ARM 1: AdMSC: Adipose derived mesenchymal stem cells; ARM 2 Placebo

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)

• Minimum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Mohit Khera

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohit Khera, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 25974235 (View on PubMed)

Other Identifiers

H-34570 No.11-13-40-07

Identifier Type: -

Identifier Source: org_study_id