Stem Cell Treatment of Peyronie´s Disease.

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

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.

Study Overview

• Status: Completed
• Conditions: Penile Diseases; Penile Induration
• Intervention / Treatment: Drug: Stromal vascular fraction

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• Denmark
  • Esbjerg, Denmark, 6700
    • Sydvejstjysk Sygehus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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]

Collaborators and Investigators

• Sponsor: Esbjerg Hospital - University Hospital of Southern Denmark
• Collaborators: Odense University Hospital
• Investigators: Principal Investigator: Majken Wiborg, MD, Hospital, Southwest Jytland

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2022
• Primary Completion (Actual): December 15, 2023
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: February 12, 2021
• First Submitted That Met QC Criteria: February 23, 2021
• First Posted (Actual): February 25, 2021

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 30, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Erectile dysfunction; Stromal vascular fraction; Peyronie´s disease; Peyronie´s disease questionnaire
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Penile Diseases; Penile Induration
• Other Study ID Numbers: 2020-SVS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No