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Erectile DysfunctionPhase 1PMD-MSC-ED-01NCT02398370

Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of Mild to Moderate ED

A Phase 1 study testing Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) in people with Erectile Dysfunction, run by Melissa Marchand at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 70 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
Jul 2013to Mar 2015
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 70 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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)
  • 10. 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

Who cannot join

  • 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
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  • 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
  • Systemic autoimmune disorder
  • Significant active systemic or localized infection
  • Receiving immunosuppressant medications

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Z Urology

    Coral Springs, Florida, 33076

Other trials in United States

About this study

Official title: Evaluate the Safety and Feasibility of Injecting Placental Matrix-Derived Mesenchymal Stem Cells Into the Penis to Treat the Symptoms of Mild to Moderate Erectile Dysfunction

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.

Read the detailed description

An estimated 18 million men in the United States are diagnosed with Erectile Dysfunction (ED). ED is a physical condition triggered by a man's mental, emotional, and medical state. Defined by the repeated and consistent problem sustaining an erection suitable for sexual intercourse; ED can lead to performance anxiety and depression as a result partners of men with ED also suffer emotional and psychological effects.

Lifestyle, smoking, medical conditions such as diabetes, hypertension and vascular problems, prostate cancer and medication side effects all can contribute to the cause of ED.

Conservative treatments can begin with lifestyle change; natural remedies include the use of herbs such as L-Arginine, Ginko, Zinc, and Yohimbe. Prescription medications known as phosphodiesterase type 5 inhibitors are often used but are costly. other therapies involve the penis pump/penis vacuum, penile implants that offer a permanent solution and surgery to improve the blood flow to the penis can improve erections.

Mesenchymal stem cells (MSCs) have been used for a variety of medical treatments to repair and regenerate acute and chronically damaged tissues. These cells have the potential to repair human tissue by forming cells of mesenchymal origin, such as cartilage, bone, fat, muscle, and blood vessels. Most research has focused on bone marrow derived stem cells (BMC) however the process for harvesting the cells is invasive, painful, and yields a low cell count. The human placenta offers an alternative source form MSCs. Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) are compromised of a novel cellular repair matrix derived from placental mesenchyme. Mesenchyme is the meshwork of embryonic connective tissue in the mesoderm, from which are formed the muscular and connective tissues of the body and also the blood vessels. PMD-MSCs provide the extracellular matrix viable mesenchymal stem cells (MSCs) that coordinate the tissue repair process, regenerative growth factors, and anti-inflammatory cytokines required to regenerate the damaged vasculature of the penile corpora.

Injecting PMD-MSCs into the penile corpora to replace the dysfunctional or dead cells is an intriguing option for cell-based treatment for ED. The research proposed here will establish the safety and feasibility of utilizing intracavernosal injections of PMD-MSCs to treat Erectile Dysfunction.

Being tested
Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
Keywords
ED
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Ovation

Study groups in NCT02398370
Study groupRoleWhat they receive
Injection of PMD-MSCs into the penisExperimentalSubjects 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.
Receives: Biological: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Peak Systolic Velocity without trimix (cm/s)

    Measured: Baseline

  2. Peak Systolic Velocity without trimix (cm/s)

    Measured: 6 weeks

  3. Peak Systolic Velocity without trimix (cm/s)

    Measured: 3 months

  4. Peak Systolic Velocity without trimix (cm/s)

    Measured: 6 months

  5. Peak Systolic Velocity without trimix (cm/s)

    Measured: 12 months

Secondary outcomes (5)

  1. End Diastolic Velocity without trimix (cm/s)

    Measured: Baseline

  2. End Diastolic Velocity without trimix (cm/s)

    Measured: 6 weeks

  3. End Diastolic Velocity without trimix (cm/s)

    Measured: 3 months

  4. End Diastolic Velocity without trimix (cm/s)

    Measured: 6 months

  5. End Diastolic Velocity without trimix (cm/s)

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2015 (estimated)
  2. Study startJul 2013
  3. Primary completionDec 2014
  4. Study completionMar 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02398370
Sponsor's protocol ID
PMD-MSC-ED-01
Acronym
PMD-MSC-ED-01
Status last verified
Apr 2015
First submitted
9 Mar 2015
Last updated
27 Apr 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26745574

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) in people with Erectile Dysfunction, run by Melissa Marchand at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peak Systolic Velocity without trimix (cm/s) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02398370, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2015.

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