NCT02395029

Brief Summary

Prospective, open labeled, 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 Peyronie's Disease. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for re-injection at 3 months and/or 6 months as 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
5

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 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

August 1, 2013

Completed
1.3 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
11 days until next milestone

First Posted

Study publicly available on registry

March 20, 2015

Completed
Last Updated

March 20, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

March 9, 2015

Last Update Submit

March 16, 2015

Conditions

Peyronie's Disease

Keywords

PD

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 (50)

  • 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

  • +47 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 on ultrasound guided measurements of penile plaque(s) post treatment and on 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

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acquired penile curvature \>15 and \<90 degrees associated with palpable penile plaque on physical examination
  • or 2 penile plaque at screening

You may not qualify if:

  • taking the medication Coumadin
  • unable to achieve adequate erection with penile injection to access degree of curvature
  • undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
  • prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorder including major depression, schizophrenia, bipolar disease
  • history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
  • clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
  • received any other investigational drug within 30 days

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, Zribi G, Zahalsky MP. Effects of Stem Cell Treatment in Human Patients With Peyronie Disease. J Am Osteopath Assoc. 2015 Oct;115(10):e8-13. doi: 10.7556/jaoa.2015.124.

    PMID: 26414724DERIVED

MeSH Terms

Conditions

Penile Induration

Condition Hierarchy (Ancestors)

Penile DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue Diseases

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
PA-C

Study Record Dates

First Submitted

March 9, 2015

First Posted

March 20, 2015

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

March 20, 2015

Record last verified: 2015-03

Locations

US(1)