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.
Who can participate
Age range
18 Years – 80 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the bend of the erect penis
Timeframe: [measured at baseline, 1, 3, 6, 12 months]
Trial details
NCT IDNCT04771442
SponsorEsbjerg Hospital - University Hospital of Southern Denmark
. 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.
. 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.