Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil

Phase 1

Not yet recruiting

• Conditions: Erectile Dysfunctions

• Registration Number: NCT06839651
• Lead Sponsor: Indonesia University

Brief Summary

The study is an experimental pre-post-test design involving 10 patients with severe ED non-responsive to sildenafil. Safety parameters included pain, hematoma, local bleeding, and infection, while efficacy was measured using the IIEF-5 questionnaire, EHS, and morning erection.

Detailed Description

The study employed umbilical cord mesenchymal stem cell secretome, one intravenous injection containing one ml into two locations, one injection in one cavernous body, and three direct follow-ups with the patient: directly after injection, one day and one month after the injection.

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-02-16
• Study First Posted: 2025-02-21
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25
• Study Start: 2025-04-21
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Men aged 40-65 years who undergo treatment at the Andrology Clinic of RSUD Dr. Soetomo.
• Severe erectile dysfunction caused by organic factors for at least 6 months, based on an IIEF-5 score of 5-7
• History of undergoing treatment with sildenafil 100 mg for four sessions.
• Evaluation of IIEF-5 score < 22 and not meeting the MCID criteria, defined as an IIEF-5 score increase of less than 4
• Type II Diabetes Melitus with an HbA1c test result of < 7%.
• Laboratory test results for liver function (SGOT and SGPT) and kidney function (urea and creatinine) are within normal limits.
• Patients with undergoing treatment with antidepressant.

Exclusion Criteria

• Anatomical abnormalities of the penis that are clinically visible, such as Peyronie's disease, a history of priapism, a history of penile implants, skin irritation, and lesions in the area surrounding the penile skin.
• Active and significant systemic or local infection.
• History of bleeding or blood clotting disorder therapy.
• History of systemic autoimmune disorders and immunosuppressive treatment
• History of prostate surgery, history of malignancy, or a PSA level > 4 ng/mL.
• Untreated hypogonadism or low serum total testosterone (<200 ng/dL).
• Uncontrolled hypertension or hypotension (systolic blood pressure >170 or <90 mmHg, and diastolic blood pressure >100 or <50 mmHg).
• Unstable cardiovascular disease (e.g., unstable angina, myocardial infarction within the last 6 months, and congestive heart failure).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual analog scale	one hour and one year	A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.
Hematomes	one hour	Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
Bleeding	one hour	Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.
Erection hardness score	one year	Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)