NCT07245875Completed
Umbilical Cord Mesenchymal Stem Cell Secretome Administration in Severe Erectile Dysfunction Non-responsive to Sildenafil
Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Severe Erectile Dysfunction Non-responsive to Sildenafil
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
The study is an experimental pre-post-test design involving 12 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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 3 Aug 2025
- Start date
- 12 Apr 2024
- Primary completion date
- 1 Aug 2025
- Lead sponsor
- Universitas Indonesia
- Diseases
- Type 2 diabetes
- NCT number
- NCT07245875
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 12 Apr 2024 to the primary completion date, 1 Aug 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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).
Lab values
- Untreated hypogonadism or low serum total testosterone (\<200 ng/dL).
Who the study is looking for
- 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.
Age in the registry: 40 years to 65 years · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Univesitas Indonesia Hospital Coordinator of this site? Confirm its status | Depok | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.