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| Name | Class |
|---|---|
| Odense University Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stromal vascular fraction injection | Experimental | Intervention: Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stromal vascular fraction | Drug | Single dose |
|
| 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] |
| 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, |
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Inclusion Criteria:
Exclusion Criteria:
Patients may not be:
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| Name | Affiliation | Role |
|---|---|---|
| Majken Wiborg, MD | Hospital, Southwest Jytland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sydvejstjysk Sygehus | Esbjerg | 6700 | Denmark |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 8, 2024 | |
| Reset | Jan 2, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 8, 2024 | Jan 2, 2025 |
| ID | Term |
|---|---|
| D010411 | Penile Induration |
| D010409 | Penile Diseases |
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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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] |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012735 | Sexual Dysfunction, Physiological |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |