Stem Cell Treatment of Peyronie´s Disease.

  • STATUS
    Recruiting
  • End date
    Sep 13, 2023
  • participants needed
    23
  • sponsor
    Hospital of South West Jutland
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Updated on 13 June 2022
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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.

Details
Condition Penile Induration, Penile Diseases
Treatment Stromal Vascular Fraction
Clinical Study IdentifierNCT04771442
SponsorHospital of South West Jutland
Last Modified on13 June 2022

Eligibility

 Yes No Not Sure

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
Clear my responses
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