Stem Cell Treatment of Peyronie´s Disease.

NCT ID: NCT04771442

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-09
• Study Completion Date: 2024-05-30

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.

Conditions

Penile Induration; Penile Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stromal vascular fraction injection

Intervention:

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

Group Type: EXPERIMENTAL

Stromal vascular fraction

Intervention Type: DRUG

Single dose

Interventions

Stromal vascular fraction

Single dose

Intervention Type: DRUG

Other Intervention Names

SVF

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Odense University Hospital

OTHER

Sponsor Role: collaborator

Esbjerg Hospital - University Hospital of Southern Denmark

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Majken Wiborg, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital, Southwest Jytland

Locations

Sydvejstjysk Sygehus

Esbjerg, , Denmark

Countries

Denmark

Other Identifiers

2020-SVS

Identifier Type: -

Identifier Source: org_study_id