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

NCT07245875 | Completed

• 2 other identifiers: 23-04-0512PUTI Q1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Erectile Dysfunction; Diabetes Mellitus Type 2

Keywords

erectile dysfunction; non responsive to sildenafil; secretome; Umbilical Cord Mesenchymal Stem Cell

Outcome Measures

Primary Outcomes (10)

• Visual Analog Scale

  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.

  one day and one month

• Hematomes

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

  one day and one month

• Bleeding

  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.

  one day and one month

• Erection Hardness Score

  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).

  One month

• IIEF-5

  Rapid diagnostic tool to evaluate erectile dysfunction

  One month

• Restrictive Index

  one month

• PSV

  one month

• SPL

  one month

• FPL

  one month

• Penile Circumference

  one month

Study Arms (1)

severe erectile dysfunction non responsive to Sildenafil

EXPERIMENTAL

Biological: Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome

Interventions

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.

severe erectile dysfunction non responsive to Sildenafil

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Male patients with severe erectile dysfunction non-responsive sildenafil
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Univesitas Indonesia Hospital

Depok, West Java, 16424, Indonesia

Location

MeSH Terms

Conditions

Erectile Dysfunction; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Ph.D

Study Record Dates

• First Submitted: August 3, 2025
• First Posted: November 24, 2025
• Study Start: April 12, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2025
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)