Stem Cell Treatment of Peyronie´s Disease.

Study Overview
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Brief Summary
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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.

Official Title
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Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans

Conditions
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Penile Induration, Penile Diseases

Intervention / Treatment
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* Drug: Stromal vascular fraction


Participation Criteria
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Eligibility Criteria
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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: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stromal vascular fraction injection<br>Intervention: Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque. | Drug: Stromal vascular fraction<br>* Single dose<br>* Other names: SVF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the bend of the erect penis | Changes in degrees measured with a goniometer compared to baseline | [measured at baseline, 1, 3, 6, 12 months] | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 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 at baseline, 1, 3, 6, 12 months]. | 
| Change in stretched Penile Length from symphysis to meatus of the glans (cm) | Ruler | [measured at baseline, 1, and 12 months] | 
| Change in penile Plaque size (mm3) | Ultrasonic scanner | [measured at baseline, 1, and 12 months] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stromal vascular fraction, Peyronie´s disease, Peyronie´s disease questionnaire, Erectile dysfunction