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

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexMale
Age40-65
SponsorIndonesia University

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • uc-msc secretome intra cavernous injection

Treatment groups

10 Participants
are divided into 1 treatment group

Locations

This trial has no locations

Sponsors and collaborators