Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD (PMD-MSC-PD-01)
Primary Purpose
Peyronie's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
Sponsored by
About this trial
This is an interventional treatment trial for Peyronie's Disease focused on measuring PD
Eligibility Criteria
Inclusion Criteria:
- acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
- 1 or 2 penile plaque at screening
Exclusion Criteria:
- 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
Sites / Locations
- Z Urology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Injection of PMD-MSCs into the penis
Arm Description
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.
Outcomes
Primary Outcome Measures
Peak Systolic Velocity without trimix (cm/s)
Peak Systolic Velocity without trimix (cm/s)
Peak Systolic Velocity without trimix (cm/s)
Peak Systolic Velocity without trimix (cm/s)
Peak Systolic Velocity without trimix (cm/s)
Secondary Outcome Measures
End Diastolic Velocity without trimix (cm/s)
End Diastolic Velocity without trimix (cm/s)
End Diastolic Velocity without trimix (cm/s)
End Diastolic Velocity without trimix (cm/s)
End Diastolic Velocity without trimix (cm/s)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02395029
Brief Title
Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD
Acronym
PMD-MSC-PD-01
Official Title
Evaluate the Safety and Feasibility of Injecting Placental Matrix-Derived Mesenchymal Stem Cells Into the Penis to Treat the Symptoms of Peyronie's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Melissa Marchand
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
Symptoms of Peyronie's disease include penile pain and curvature of the penis that prevents penetration and/or causes erectile dysfunction (ED). It is characterized by plaques that form along the top or bottom side of the penis inside the tunica albuginea; the plaque begins as a localized inflammation then develops into a hardened scar. Cases can range from mild to severe. In several cases, the hardened plaque reduces flexibility, causing the penis to curve during erection. The sexual problems as a result can lower a man's self-esteem and interfere with a couple's physical and emotional relationship.
The cause is unknown; however, possibilities include trauma, inherited conditions, Vitamin E deficiency, diabetes, and vascular disease.
Conservative treatments used in the acute phase (initial onset of symptoms) include oral therapies. Vitamin E and antioxidants can decrease the build-up of harmful chemicals that can cause injury to tissue. It is often used as the traditional treatment; it is inexpensive and with proper dosing, there are minimal side effects. Other oral agents include Potaba (aminobenzoates potassium); however, it is expensive ($1000 per year) and has associated gastrointestinal side effects.
Other therapies involve injections directly in the plaques (intralesional) with chemicals such as collagenase or calcium-channel blockers.
Surgical therapies are offered once the disease is stable (symptoms present for one year). Invasive surgical options consist of correction of the penile curvature or the placement of a penile prosthesis to straighten the penis to allow for 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.
The research proposed here will establish the safety and feasibility of utilizing intracavernosal, intralesional injections of PMD-MSCs to treat Peyronie's disease with the intent of avoiding surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peyronie's Disease
Keywords
PD
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Injection of PMD-MSCs into the penis
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
Other Intervention Name(s)
Ovation
Primary Outcome Measure Information:
Title
Peak Systolic Velocity without trimix (cm/s)
Time Frame
Baseline
Title
Peak Systolic Velocity without trimix (cm/s)
Time Frame
6 weeks
Title
Peak Systolic Velocity without trimix (cm/s)
Time Frame
3 months
Title
Peak Systolic Velocity without trimix (cm/s)
Time Frame
6 months
Title
Peak Systolic Velocity without trimix (cm/s)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
End Diastolic Velocity without trimix (cm/s)
Time Frame
Baseline
Title
End Diastolic Velocity without trimix (cm/s)
Time Frame
6 weeks
Title
End Diastolic Velocity without trimix (cm/s)
Time Frame
3 months
Title
End Diastolic Velocity without trimix (cm/s)
Time Frame
6 months
Title
End Diastolic Velocity without trimix (cm/s)
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Peak Systolic Velocity with trimix (cm/s)
Time Frame
Baseline
Title
Peak Systolic Velocity with trimix (cm/s)
Time Frame
6 weeks
Title
Peak Systolic Velocity with trimix (cm/s)
Time Frame
3 months
Title
Peak Systolic Velocity with trimix (cm/s)
Time Frame
6 months
Title
Peak Systolic Velocity with trimix (cm/s)
Time Frame
12 months
Title
End Diastolic Velocity with trimix (cm/s)
Time Frame
Baseline
Title
End Diastolic Velocity with trimix (cm/s)
Time Frame
6 weeks
Title
End Diastolic Velocity with trimix (cm/s)
Time Frame
3 months
Title
End Diastolic Velocity with trimix (cm/s)
Time Frame
6 months
Title
End Diastolic Velocity with trimix (cm/s)
Time Frame
12 months
Title
Rigidity test (Pass or Fail)
Time Frame
Baseline
Title
Rigidity test (Pass or Fail)
Time Frame
6 weeks
Title
Rigidity test (Pass or Fail)
Time Frame
3 months
Title
Rigidity test (Pass or Fail)
Time Frame
6 months
Title
Rigidity test (Pass or Fail)
Time Frame
12 months
Title
Stretched Penile Length before trimix (cm/s)
Time Frame
Baseline
Title
Stretched Penile Length before trimix (cm/s)
Time Frame
6 weeks
Title
Stretched Penile Length before trimix (cm/s)
Time Frame
3 months
Title
Stretched Penile Length before trimix (cm/s)
Time Frame
6 months
Title
Stretched Penile Length before trimix (cm/s)
Time Frame
12 months
Title
Post Penile Width with trimix
Time Frame
Baseline
Title
Post Penile Width with trimix
Time Frame
6 weeks
Title
Post Penile Width with trimix
Time Frame
3 months
Title
Post Penile Width with trimix
Time Frame
6 months
Title
Post Penile Width with trimix
Time Frame
12 months
Title
International Index of Erectile Function (IIEF)
Time Frame
Baseline
Title
International Index of Erectile Function (IIEF)
Time Frame
6 weeks
Title
International Index of Erectile Function (IIEF)
Time Frame
3 months
Title
International Index of Erectile Function (IIEF)
Time Frame
6 months
Title
International Index of Erectile Function (IIEF)
Time Frame
12 months
Title
#1 Penile Plaque (Location) Size (mm^3)
Time Frame
Baseline
Title
#1 Penile Plaque (Location) Size (mm^3)
Time Frame
6 weeks
Title
#1 Penile Plaque (Location) Size (mm^3)
Time Frame
3 months
Title
#1 Penile Plaque (Location) Size (mm^3)
Time Frame
6 months
Title
#1 Penile Plaque (Location) Size (mm^3)
Time Frame
12 months
Title
#2 Penile Plaque (Location) Size (mm^3)
Time Frame
Baseline
Title
#2 Penile Plaque (Location) Size (mm^3)
Time Frame
6 weeks
Title
#2 Penile Plaque (Location) Size (mm^3)
Time Frame
3 months
Title
#2 Penile Plaque (Location) Size (mm^3)
Time Frame
6 months
Title
#2 Penile Plaque (Location) Size (mm^3)
Time Frame
12 months
Title
#3 Penile Plaque (Location)Size (mm^3)
Time Frame
Baseline
Title
#3 Penile Plaque (Location)Size (mm^3)
Time Frame
6 weeks
Title
#3 Penile Plaque (Location)Size (mm^3)
Time Frame
3 months
Title
#3 Penile Plaque (Location)Size (mm^3)
Time Frame
6 months
Title
#3 Penile Plaque (Location)Size (mm^3)
Time Frame
12 months
Title
Penile Curvature Angle (degrees)
Time Frame
Baseline
Title
Penile Curvature Angle (degrees)
Time Frame
6 weeks
Title
Penile Curvature Angle (degrees)
Time Frame
3 months
Title
Penile Curvature Angle (degrees)
Time Frame
6 months
Title
Penile Curvature Angle (degrees)
Time Frame
12 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
1 or 2 penile plaque at screening
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael P. Zahalsky, M.D.
Organizational Affiliation
Z Urology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Z Urology
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33076
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26414724
Citation
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.
Results Reference
derived
Learn more about this trial
Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD
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