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NOT YET RECRUITING
NCT06839651
PHASE1

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

Sponsor: Indonesia University

View on ClinicalTrials.gov

Summary

The study is an experimental pre-post-test design involving 10 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.

Official 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

Key Details

Gender

MALE

Age Range

40 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

10

Start Date

2025-04-21

Completion Date

2026-04-01

Last Updated

2025-02-25

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

uc-msc secretome intra cavernous injection

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.