Penile IndurationPhase 1NCT04771442
Stem Cell Treatment of Peyronie´s Disease.
A Phase 1 study testing Stromal vascular fraction in people with Penile Induration and Penile Diseases, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
Trial summary
Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment. Twentythree men > 18 years with Peyronie´s Disease in the chronic phase will be recruited. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Penile Induration, Penile Diseases
- What is being tested?
- Stromal vascular fraction
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Sep 2022to 30 May 2024
- 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acquired penile curvature >30 and <90 degrees associated with a palpable penile plaque on physical examination.
- One or several plaques at ultrasound screening.
- Willingness to attend follow-up at 1, 3, 6 and 12 months.
- Understand and speak Danish.
- Men > 18 years of age
Who cannot join
- Patients may not be:
- Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
- Unable to achieve adequate erection with penile injection to access degree of curvature.
- Undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy.
- With 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 disorders including but not limited to major depression, schizophrenia, bipolar disease.
- With a history of cerebrovascular incidents, a history of deep venous thrombosis within the past 5 years or a history of untreated or severe sleep apnoea.
Show all 11Show fewer
- With a clinically significant abnormal, results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator. Blood tests will be analysed for HIV, Hepatitis B and C and syphilis and those applicable within guidelines of the department.
- Involved with any other projects with an investigational drug within 30 days.
- In treatment for alcohol or drug abuse within six months.
- With congenital deviation of penis.
- Within six months treated with Collagenase, ESWT and/or other therapeutic injection in the plaque treatment for PD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment.
Twentythree men > 18 years with Peyronie´s Disease in the chronic phase will be recruited.
The operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. Before the patient wake, local anaesthesia is put around the penis. Processed stem cells are injected into the plaque/fibrosis subcutaneously.
There will be a follow up at 1, 3, 6, 12 months. It is a pilot study with no randomisation. The group will be compared to a historical control group.
- Conditions
- Penile Induration, Penile Diseases
- Being tested
- Stromal vascular fraction
- Keywords
- Stromal vascular fraction, Peyronie´s disease, Peyronie´s disease questionnaire, Erectile dysfunction
- Medical subject headings
- Penile Induration, Penile Diseases, Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stromal vascular fractionDrug
Also called SVF
Single dose
| Study group | Role | What they receive |
|---|---|---|
| Stromal vascular fraction injection | Experimental | Intervention:
Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque. Receives: Drug: Stromal vascular fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the bend of the erect penis
Changes in degrees measured with a goniometer compared to baseline
Measured: [measured at baseline, 1, 3, 6, 12 months]
Secondary outcomes (4)
Change in Peyronie´s disease questionnaire bother symptoms
Will there be less bother symptoms compared to baseline? Score 0-44. The higher the score the more symptoms.
Measured: [measured at baseline, 1, 3, 6, 12 months]
Change in International Index of Erectile Function score,
Score can be 5-25, the higher the score the less symptoms. Answers are compared to baseline.
Measured: [measured at baseline, 1, 3, 6, 12 months].
Change in stretched Penile Length from symphysis to meatus of the glans (cm)
Ruler
Measured: [measured at baseline, 1, and 12 months]
Change in penile Plaque size (mm3)
Ultrasonic scanner
Measured: [measured at baseline, 1, and 12 months]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start9 Sep 2022
- Primary completion15 Dec 2023
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Penile IndurationStudies 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern Denmark
- Sponsor type
- University, hospital or other
- Collaborators
- Odense University Hospital
- Responsible party
- Sponsor
- Investigators
- Majken Wiborg, MD, Principal investigator, Hospital, Southwest Jytland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771442
- Sponsor's protocol ID
- 2020-SVS
- Status last verified
- Jul 2024
- First submitted
- 12 Feb 2021
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
- ClinicalTrials.gov ID
- NCT04771442
- Acronym / sponsor ID
- 2020-SVS
- Conditions
- Penile Induration, Penile Diseases
- Keywords
- Stromal vascular fraction, Peyronie´s disease, Peyronie´s disease questionnaire, Erectile dysfunction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Esbjerg Hospital - University Hospital of Southern DenmarkUniversity, hospital or other
- Collaborators
- Odense University Hospital
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 25 Feb 2021 (actual)
- 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.
Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment.
Twentythree men > 18 years with Peyronie´s Disease in the chronic phase will be recruited.
The operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. Before the patient wake, local anaesthesia is put around the penis. Processed stem cells are injected into the plaque/fibrosis subcutaneously.
There will be a follow up at 1, 3, 6, 12 months. It is a pilot study with no randomisation. The group will be compared to a historical control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stromal vascular fraction injection | Experimental | Drug: Stromal vascular fractionIntervention: Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Acquired penile curvature >30 and <90 degrees associated with a palpable penile plaque on physical examination.
- One or several plaques at ultrasound screening.
- Willingness to attend follow-up at 1, 3, 6 and 12 months.
- Understand and speak Danish.
- Men > 18 years of age
Key exclusion criteria (11 listed)
- Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
- Unable to achieve adequate erection with penile injection to access degree of curvature.
- Undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy.
- With 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 disorders including but not limited to major depression, schizophrenia, bipolar disease.
- With a history of cerebrovascular incidents, a history of deep venous thrombosis within the past 5 years or a history of untreated or severe sleep apnoea.
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 |
|---|---|---|
| Stromal vascular fractionAlso: SVFSingle dose | Drug | Stromal vascular fraction injection |
Primary outcome
Change in the bend of the erect penis
Time frame: [measured at baseline, 1, 3, 6, 12 months]
Changes in degrees measured with a goniometer compared to baseline
4 secondary outcomes
Change in Peyronie´s disease questionnaire bother symptoms
Time frame: [measured at baseline, 1, 3, 6, 12 months]
Change in International Index of Erectile Function score,
Time frame: [measured at baseline, 1, 3, 6, 12 months].
Change in stretched Penile Length from symphysis to meatus of the glans (cm)
Time frame: [measured at baseline, 1, and 12 months]
Change in penile Plaque size (mm3)
Time frame: [measured at baseline, 1, and 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 31 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Penile Induration
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Platelet-Rich Plasma for Peyronie's Disease
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Delayed Dose Collagenase Clostridium Histolyticum (CCH) Protocol for Men With Peyronie's Disease
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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.
Majken Wiborg, MD principal investigator
Hospital, Southwest Jytland
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 Stromal vascular fraction in people with Penile Induration and Penile Diseases, run by Esbjerg Hospital - University Hospital of Southern Denmark at 1 site in Denmark.
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 5 inclusion and 11 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 31 Jul 2024. 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 Denmark. 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?
Change in the bend of the erect penis (time frame: [measured at baseline, 1, 3, 6, 12 months]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024.