NCT02398370

Brief Summary

Prospective, open-label, non-randomized, study to be conducted at a single center. Ten subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) into the penis for the treatment of mild to moderate erectile dysfunction. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be evaluated for re-injection beginning at 3 months. Eligibility is determined by the clinician based on patient reported treatment satisfaction.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2013

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 9, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 25, 2015

Completed
Last Updated

April 27, 2015

Status Verified

April 1, 2015

Enrollment Period

1.4 years

First QC Date

March 9, 2015

Last Update Submit

April 24, 2015

Conditions

Erectile Dysfunction

Keywords

ED

Outcome Measures

Primary Outcomes (5)

  • Peak Systolic Velocity without trimix (cm/s)

    Baseline

  • Peak Systolic Velocity without trimix (cm/s)

    6 weeks

  • Peak Systolic Velocity without trimix (cm/s)

    3 months

  • Peak Systolic Velocity without trimix (cm/s)

    6 months

  • Peak Systolic Velocity without trimix (cm/s)

    12 months

Secondary Outcomes (5)

  • End Diastolic Velocity without trimix (cm/s)

    Baseline

  • End Diastolic Velocity without trimix (cm/s)

    6 weeks

  • End Diastolic Velocity without trimix (cm/s)

    3 months

  • End Diastolic Velocity without trimix (cm/s)

    6 months

  • End Diastolic Velocity without trimix (cm/s)

    12 months

Other Outcomes (30)

  • Peak Systolic Velocity with trimix (cm/s)

    Baseline

  • Peak Systolic Velocity with trimix (cm/s)

    6 weeks

  • Peak Systolic Velocity with trimix (cm/s)

    3 months

  • +27 more other outcomes

Study Arms (1)

Injection of PMD-MSCs into the penis

EXPERIMENTAL

Subjects will receive an initial injection of 1.0cc of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs). Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based patient reported treatment satisfaction.

Biological: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)

Interventions

Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)BIOLOGICAL
Also known as: Ovation
Injection of PMD-MSCs into the penis

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men aged 40-70
  • Willing and able to provide written informed consent
  • Chronic, organic erectile dysfunction (ED), duration at least 0.5 years, with baseline International Index of Erectile Function-Erectile Function (IIEF-EF) score greater than or equal to 21
  • Willing to complete questionnaires
  • Involved in a monogamous, heterosexual relationship for at least 3 months with both partners motivated to have or attempt sexual intercourse at least 4 times per month beginning two weeks after study treatment (subject reported)
  • Not interested or able to use oral PDE-5 inhibitor (PDE-5i) drug therapy, and willing to forgo these treatments for the first 6-month period following study treatment (in addition may include a 4-week washout since last PDE-5i use prior to completion of the baseline erectile function assessments and study treatment)
  • Willing to limit alcohol intake and eliminate use of recreational drugs for sexual encounters
  • Willing to undergo an injection 9 Mentally competent and able to understand all study requirements (based on investigator assessment)
  • \. Willing to be available for all baseline, treatment, and follow up examinations required by protocol 11. Willing to forego participation in any other study throughout the duration of this study

You may not qualify if:

  • Evidence of prostate cancer which requires additional radiotherapy or other adjuvant therapy
  • Previous pelvic or abdominal radiation therapy
  • Previous, concomitant or scheduled use of anti-androgen therapy
  • Untreated hypogonadism or low serum total testosterone (\<200 ng/dL)
  • Clinically evident penile anatomical deformities (e.g., Peyronie's disease) or history of priapism
  • Skin irritation, infection, wound, sore, or disruption in the immediate areas of skin entry for penile injection
  • Use of any non-study treatment for erectile dysfunction within 4 weeks of study treatment and a lack of willingness to continue through 6 months after study treatment
  • Any previous penile implant or penile vascular surgery
  • Current or previous malignancy other than localized prostate cancer
  • Uncontrolled hypertension or hypotension (systolic blood pressure \> 170 or \<90 mm Hg, and diastolic blood pressure \> 100 or \< 50 mm Hg)
  • Reported unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the past 6 months, cardiac failure or life-threatening arrhythmia, congestive heart failure) or symptomatic postural hypotension within 6 months before screening
  • Current urinary tract or bladder infection
  • Drug, alcohol, or substance abuse reported within the last three years (subject reported) Subject's sexual partner \< 18 years of age or has any gynecologic problems
  • Major medical conditions, or any other factors that would limit participation in sexual intercourse to less than 4 times per month (subject reported)
  • Weight less than 154lbs/ 70 kg, or BMI greater than or equal to 30
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Z Urology

Coral Springs, Florida, 33076, United States

Location

Related Publications (1)

  • Levy JA, Marchand M, Iorio L, Cassini W, Zahalsky MP. Determining the Feasibility of Managing Erectile Dysfunction in Humans With Placental-Derived Stem Cells. J Am Osteopath Assoc. 2016 Jan;116(1):e1-5. doi: 10.7556/jaoa.2016.007.

    PMID: 26745574DERIVED

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

  • Michael P. Zahalsky, M.D.

    Z Urology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 25, 2015

Study Start

July 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

April 27, 2015

Record last verified: 2015-04

Locations

US(1)