Back to resultsStem Cell Treatment of Peyronie´s Disease.
Primary Purpose
Penile Induration, Penile Diseases
Status
Active
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
Stromal vascular fraction
Sponsored by
About this trial
This is an interventional treatment trial for Penile Induration focused on measuring Stromal vascular fraction, Peyronie´s disease, Peyronie´s disease questionnaire, Erectile dysfunction
Eligibility Criteria
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.
Sites / Locations
- Sydvejstjysk Sygehus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stromal vascular fraction injection
Arm Description
Intervention: Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque.
Outcomes
Primary Outcome Measures
Change in the bend of the erect penis
Changes in degrees measured with a goniometer compared to baseline
Secondary Outcome Measures
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.
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.
Change in stretched Penile Length from symphysis to meatus of the glans (cm)
Ruler
Change in penile Plaque size (mm3)
Ultrasonic scanner
Full Information
NCT ID
NCT04771442
First Posted
February 12, 2021
Last Updated
April 25, 2023
Sponsor
Hospital of South West Jutland
Collaborators
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04771442
Brief Title
Stem Cell Treatment of Peyronie´s Disease.
Official Title
Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 9, 2022 (Actual)
Primary Completion Date
December 15, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital of South West Jutland
Collaborators
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Penile Induration, Penile Diseases
Keywords
Stromal vascular fraction, Peyronie´s disease, Peyronie´s disease questionnaire, Erectile dysfunction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stromal vascular fraction injection
Arm Type
Experimental
Arm Description
Intervention:
Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque.
Intervention Type
Drug
Intervention Name(s)
Stromal vascular fraction
Other Intervention Name(s)
SVF
Intervention Description
Single dose
Primary Outcome Measure Information:
Title
Change in the bend of the erect penis
Description
Changes in degrees measured with a goniometer compared to baseline
Time Frame
[measured at baseline, 1, 3, 6, 12 months]
Secondary Outcome Measure Information:
Title
Change in Peyronie´s disease questionnaire bother symptoms
Description
Will there be less bother symptoms compared to baseline? Score 0-44. The higher the score the more symptoms.
Time Frame
[measured at baseline, 1, 3, 6, 12 months]
Title
Change in International Index of Erectile Function score,
Description
Score can be 5-25, the higher the score the less symptoms. Answers are compared to baseline.
Time Frame
[measured at baseline, 1, 3, 6, 12 months].
Title
Change in stretched Penile Length from symphysis to meatus of the glans (cm)
Description
Ruler
Time Frame
[measured at baseline, 1, and 12 months]
Title
Change in penile Plaque size (mm3)
Description
Ultrasonic scanner
Time Frame
[measured at baseline, 1, and 12 months]
10. Eligibility
Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Majken Wiborg, MD
Organizational Affiliation
Hospital, Southwest Jytland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydvejstjysk Sygehus
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Stem Cell Treatment of Peyronie´s Disease.
We'll reach out to this number within 24 hrs