Status:
COMPLETED
Stem Cell Treatment of Peyronie´s Disease.
Lead Sponsor:
Esbjerg Hospital - University Hospital of Southern Denmark
Collaborating Sponsors:
Odense University Hospital
Conditions:
Penile Induration
Penile Diseases
Eligibility:
MALE
18-80 years
Phase:
PHASE1
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 Peyron...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 30 2024
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT04771442
Start Date
September 9 2022
End Date
May 30 2024
Last Update
July 31 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Sydvejstjysk Sygehus
Esbjerg, Denmark, 6700