NCT04771442

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.5 years until next milestone

Study Start

First participant enrolled

September 9, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
Last Updated

July 31, 2024

Status Verified

July 1, 2024

Enrollment Period

1.3 years

First QC Date

February 12, 2021

Last Update Submit

July 30, 2024

Conditions

Penile IndurationPenile Diseases

Keywords

Stromal vascular fractionPeyronie´s diseasePeyronie´s disease questionnaireErectile dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Change in Peyronie´s disease questionnaire bother symptoms

    [measured at baseline, 1, 3, 6, 12 months]

  • Change in International Index of Erectile Function score,

    [measured at baseline, 1, 3, 6, 12 months].

  • Change in stretched Penile Length from symphysis to meatus of the glans (cm)

    [measured at baseline, 1, and 12 months]

  • Change in penile Plaque size (mm3)

    [measured at baseline, 1, and 12 months]

Study Arms (1)

Stromal vascular fraction injection

EXPERIMENTAL

Intervention: Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque.

Drug: Stromal vascular fraction

Interventions

Stromal vascular fractionDRUG

Single dose

Also known as: SVF
Stromal vascular fraction injection

Eligibility Criteria

Age18 Years - 80 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydvejstjysk Sygehus

Esbjerg, 6700, Denmark

Location

MeSH Terms

Conditions

Penile IndurationPenile DiseasesErectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMental Disorders

Study Officials

  • Majken Wiborg, MD

    Hospital, Southwest Jytland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2021

First Posted

February 25, 2021

Study Start

September 9, 2022

Primary Completion

December 15, 2023

Study Completion

May 30, 2024

Last Updated

July 31, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)