Skip to main content
OpenTrials
Completed

NCT Number: NCT04771442

Stem Cell Treatment of Peyronie´s Disease.

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stromal vascular fraction

Drug

Single dose

Other names: SVF

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Esbjerg Hospital - University Hospital of Southern Denmark

Other

Collaborators

  • Odense University Hospital

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Feb 25, 2021
Registry last updated
Jul 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.