PRP for the Treatment of Erectile Dysfunction (ED)

NCT04350125 | Completed Phase 1 FDA Drug

• 1 other identifier: 18-010364
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in the treatment of Erectile Dysfunction (ED).

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• Treatment-related adverse events

  Number of participants to experience treatment-related adverse events defined as reaction in the skin (e.g., swelling, erythema, and warmth), injection site discomfort, penile pain, change in penile appearance, novel sexual concerns and any systemic reactions seen by the investigators, or concerns expressed by patients.

  35 weeks

Study Arms (1)

Platelet Rich Plasma Treatment

EXPERIMENTAL

Male subjects diagnosed with Erectile Dysfunction (ED) will receive platelet rich plasma injections.

Biological: Autologous Platelet Rich Plasma

Interventions

Autologous Platelet Rich Plasma BIOLOGICAL

One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.

Platelet Rich Plasma Treatment

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must have given his informed and signed written consent
• The patient has ED for longer than 1 year but less than 5 years.
• The subject has a stable partner for at least 3 months.
• The patient is PDE5i responsive, meaning he is able to achieve and maintain an erection under the effect of the maximal dosage of PDE5i
• IIEF-EF, EHS, SEP 2+3, and GAQ Domain score of 17-20 Mild to moderate vascular erectile dysfunction: PSV \> 25 cm/sec

You may not qualify if:

• The patient is participating in another study that may interfere with the results or conclusions of this study
• History of radical prostatectomy or pelvic cancer surgery
• Prior history of pelvic malignancies
• Prior pelvic radiation therapy
• Neurological disease which effects erectile function (Spinal cord injury, iatrogenic injury to the pelvic or cavernous nerves)
• Psychiatric disease which effects erectile function
• The patient is taking blood thinners
• History of Diabetes Mellitus
• History of Coronary Artery Disease
• Evidence Based Criteria: Doppler Clinical Exam ( PSV \< 25 cm/sec defined criteria for severe erectile dysfunction not likely to respond to approved medical therapies)
• Biochemical evidence of Hypogonadism (total Testosterone \< 300 ng/dL)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Gregory Broderick, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 16, 2020
• Study Start: March 4, 2022
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)