NCT07245875

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Indonesia University · Academic / Other
• Sex: Male
• Age: 40 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Erectile Dysfunction
• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-04-12
• Primary completion: 2025-08-01
• Completion: 2025-08-01
• First posted: 2025-11-24
• Last updated: 2025-11-24

Locations

1 site across 1 country: Indonesia