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

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.

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Diabetes Mellitus Type 2
• Intervention / Treatment: Biological: Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • West Java
    • Depok, West Java, Indonesia, 16424
      • Univesitas Indonesia Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: severe erectile dysfunction non responsive to Sildenafil

Biological: Intracavernosal Injection of Umbilical Cord Mesenchymal Stem Cell Secretome; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): August 1, 2025

Study Registration Dates

• First Submitted: August 3, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: erectile dysfunction; Umbilical Cord Mesenchymal Stem Cell; secretome; non responsive to sildenafil
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Mental Disorders; Genital Diseases, Male; Male Urogenital Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Sexual Dysfunction, Physiological; Sexual Dysfunctions, Psychological; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Erectile Dysfunction
• Other Study ID Numbers: 23-04-0512; PUTI Q1 (Other Identifier: Universitas Indonesia)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No