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Completed

NCT Number: NCT07245875

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

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.

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Key information

Conditions

Erectile Dysfunction Diabetes Mellitus Diabetes Mellitus Type 2 Diabetes Mellitus, Type 2 Endocrine System Diseases Genital Diseases Genital Diseases, Male Glucose Metabolism Disorders Male Urogenital Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

40 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Univesitas Indonesia Hospital

Depok, West Java, 16424, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome

Biological

UC-MSC secretome was obtained from UC-MSC cultures with 80% confluence in serum-free medium after 24 hours of incubation The VEGF level in the secretome given was 1400 pg/ml.

The intervention was the administration of 0.5 mL/site of secretome injection injected intra-cavernous to all subjects using a 22-gauge needle according to a sterile protocol. The same volume was given at bilateral sites of the penile shaft. The intra-cavernous injection sites were in the right and left dorsolateral regions of the penis. After the intervention, tolerability was assessed by observing and questioning the subjects regarding pain during injection.

Primary outcomes

  1. Visual Analog Scale

    Time frame: one day and one month

    A visual analog is used for measuring pain. The patient will be asked to describe the pain on scale 1 to 10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.

  2. Hematomes

    Time frame: one day and one month

    Hematomes means blue discoloration. 0 scale means ther is no discoloration and 1 means there is discoloration.

  3. Bleeding

    Time frame: one day and one month

    Bleeding is one of the outcomes of the research. If there is bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.

  4. Erection Hardness Score

    Time frame: One month

    Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 scores. 1 indicate severe erectile dysfunction (worst) and 4 indicates there is optimal erection (good).

  5. IIEF-5

    Time frame: One month

    Rapid diagnostic tool to evaluate erectile dysfunction

  6. Restrictive Index

    Time frame: one month

  7. PSV

    Time frame: one month

  8. SPL

    Time frame: one month

  9. FPL

    Time frame: one month

  10. Penile Circumference

    Time frame: one month

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study title

Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Severe Erectile Dysfunction Non-responsive to Sildenafil

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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