Peyronie's DiseasePhase 1PMD-MSC-PD-01NCT02395029
Evaluate the Safety and Feasibility of Injecting PMD-MSC Into the Penis to Treat the Symptoms of PD
A Phase 1 study testing Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) in people with Peyronie's Disease, run by Melissa Marchand at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Peyronie's Disease
- 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
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
- 1 or 2 penile plaque at screening
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
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 Peyronie's Disease
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.
Read the 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.
- Conditions
- Peyronie's Disease
- Being tested
- Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)
- Keywords
- PD
- Medical subject headings
- Penile Induration
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 group | Role | What they receive |
|---|---|---|
| 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. 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.
Peak Systolic Velocity without trimix (cm/s)
Measured: Baseline
Peak Systolic Velocity without trimix (cm/s)
Measured: 6 weeks
Peak Systolic Velocity without trimix (cm/s)
Measured: 3 months
Peak Systolic Velocity without trimix (cm/s)
Measured: 6 months
Peak Systolic Velocity without trimix (cm/s)
Measured: 12 months
Secondary outcomes (5)
End Diastolic Velocity without trimix (cm/s)
Measured: Baseline
End Diastolic Velocity without trimix (cm/s)
Measured: 6 weeks
End Diastolic Velocity without trimix (cm/s)
Measured: 3 months
End Diastolic Velocity without trimix (cm/s)
Measured: 6 months
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.
- First posted20 Mar 2015 (estimated)
- Study startAug 2013
- Primary completionDec 2014
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peyronie's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Melissa Marchand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Melissa Marchand, Z Urology
- Investigators
- Michael P. Zahalsky, M.D., Principal investigator, Z Urology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02395029
- Sponsor's protocol ID
- PMD-MSC-PD-01
- Acronym
- PMD-MSC-PD-01
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 20 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26414724
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02395029
- Acronym / sponsor ID
- PMD-MSC-PD-01 / PMD-MSC-PD-01
- Conditions
- Peyronie's Disease
- Keywords
- PD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Melissa MarchandUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 20 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Injection of PMD-MSCs into the penis | Experimental | Biological: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
- 1 or 2 penile plaque at screening
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)Also: Ovation | Biological | Injection of PMD-MSCs into the penis |
Primary outcome
Peak Systolic Velocity without trimix (cm/s)
Time frame: Baseline
Peak Systolic Velocity without trimix (cm/s)
Time frame: 6 weeks
Peak Systolic Velocity without trimix (cm/s)
Time frame: 3 months
Peak Systolic Velocity without trimix (cm/s)
Time frame: 6 months
Peak Systolic Velocity without trimix (cm/s)
Time frame: 12 months
5 secondary outcomes
End Diastolic Velocity without trimix (cm/s)
Time frame: Baseline
End Diastolic Velocity without trimix (cm/s)
Time frame: 6 weeks
End Diastolic Velocity without trimix (cm/s)
Time frame: 3 months
End Diastolic Velocity without trimix (cm/s)
Time frame: 6 months
End Diastolic Velocity without trimix (cm/s)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2015.
- Derived from this study: PubMed 26414724Levy 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P. Zahalsky, M.D. principal investigator
Z Urology
1 site in 1 country: see every site and its status.
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 Peyronie's Disease, 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 2 inclusion and 7 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 20 Mar 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 NCT02395029, 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 20 Mar 2015.