Clinical trial NCT04771442: Stem Cell Treatment of Peyronie´s Disease.
Official title: Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Penile Induration
Penile Diseases
Keywords: Stromal vascular fraction
Peyronie´s disease
Peyronie´s disease questionnaire
Erectile dysfunction
Lead sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2021-02-25
Enrollment: 22
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Acquired penile curvature \>30 and \<90 degrees associated with a palpable penile plaque on physical examination.
2. One or several plaques at ultrasound screening.
3. Willingness to attend follow-up at 1, 3, 6 and 12 months.
4. Understand and speak Danish.
5. Men \> 18 years of age

Exclusion Criteria:

Patients may not be:

1. Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
2. Unable to achieve adequate erection with penile injection to access degree of curvature.
3. Undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy.
4. 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.
5. 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.
6. 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.
7. Involved with any other projects with an investigational drug within 30 days.
8. In treatment for alcohol or drug abuse within six months.
9. With congenital deviation of penis.
10. Within six months treated with Collagenase, ESWT and/or other therapeutic injection in the plaque treatment for PD.

Primary outcomes:
measure: Change in the bend of the erect penis
timeFrame: [measured at baseline, 1, 3, 6, 12 months]
Secondary outcomes:
measure: Change in Peyronie´s disease questionnaire bother symptoms
timeFrame: [measured at baseline, 1, 3, 6, 12 months]
measure: Change in International Index of Erectile Function score,
timeFrame: [measured at baseline, 1, 3, 6, 12 months].
measure: Change in stretched Penile Length from symphysis to meatus of the glans (cm)
timeFrame: [measured at baseline, 1, and 12 months]
measure: Change in penile Plaque size (mm3)
timeFrame: [measured at baseline, 1, and 12 months]
Other outcomes:
Locations:
city: Esbjerg
country: Denmark
facility: Sydvejstjysk Sygehus
Study officials:
affiliation: Hospital, Southwest Jytland
name: Majken Wiborg, MD
role: PRINCIPAL_INVESTIGATOR
References: