Stem Cell Treatment of Peyronie´s Disease.

• ClinicalTrials.gov Identifier: NCT04771442
• Recruitment Status: Not yet recruiting
• First Posted: February 25, 2021
• Last Update Posted: November 1, 2021
• Sponsor: Hospital of South West Jutland
• Collaborator: Odense University Hospital
• Information provided by (Responsible Party): Hospital of South West Jutland

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.

Condition or disease	Intervention/treatment	Phase
Penile Induration; Penile Diseases	Drug: Stromal vascular fraction	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 23 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
• Estimated Study Start Date: January 2022
• Estimated Primary Completion Date: August 2022
• Estimated Study Completion Date: August 2023

Arms and Interventions

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 Name: SVF

Outcome Measures

Primary Outcome Measures :

1. Change in the bend of the erect penis [ Time Frame: [measured at baseline, 1, 3, 6, 12 months] ]
   Changes in degrees measured with a goniometer compared to baseline

Secondary Outcome Measures :

1. Change in Peyronie´s disease questionnaire bother symptoms [ Time Frame: [measured at baseline, 1, 3, 6, 12 months] ]
   Will there be less bother symptoms compared to baseline? Score 0-44. The higher the score the more symptoms.
2. Change in International Index of Erectile Function score, [ Time Frame: [measured at baseline, 1, 3, 6, 12 months]. ]
   Score can be 5-25, the higher the score the less symptoms. Answers are compared to baseline.
3. Change in stretched Penile Length from symphysis to meatus of the glans (cm) [ Time Frame: [measured at baseline, 1, and 12 months] ]
   Ruler
4. Change in penile Plaque size (mm3) [ Time Frame: [measured at baseline, 1, and 12 months] ]
   Ultrasonic scanner

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Male
• Gender Based Eligibility: Yes
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Majken H Wiborg, MD; +45 26 36 22 87; majken.hojrup.wiborg@rsyd.dk

Contact: Lars Lund, Professor; +45 51408982; lars.lund@rsyd.dk

Sponsors and Collaborators

Hospital of South West Jutland

Odense University Hospital

Investigators

• Principal Investigator: Majken Wiborg, MD; Hospital, Southwest Jytland

More Information

• Responsible Party: Hospital of South West Jutland
• ClinicalTrials.gov Identifier: NCT04771442
• Other Study ID Numbers: 2020-SVS
• First Posted: February 25, 2021
• Last Update Posted: November 1, 2021
• Last Verified: October 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital of South West Jutland:

Stromal vascular fraction; Peyronie´s disease; Peyronie´s disease questionnaire; Erectile dysfunction

Additional relevant MeSH terms:

Penile Induration; Penile Diseases; Connective Tissue Diseases