Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients With Severe Erectile Dysfunction Non-responsive to Sildenafil
Phase: NA
Conditions: Erectile Dysfunction, Diabetes Mellitus Type 2
Sponsor: Indonesia University

Study Protocol
Analysis of the Safety and Efficacy of Administering
Umbilical Cord Mesenchymal Stem Cell Secretome in
Patients With Severe Erectile Dysfunction Non-responsive to
Sildenafil
Date : 6 October 2025

Introduction and Objective
Couples who have difficulties in conception are estimated to be approximately 15 % of couples in the
whole
wide
world,
which
is
a
significant
challenge
in
reproductive
medicine.
Asthenoteratozoospermia is a critical factor in infertility in males due to the low motility of sperm and
its structurally aberrant morphology. Because of the secretome that provides trophic factors, cytokines,
and growth factors, mesenchymal stem cells (MSCs) have a significant therapeutic promise in
regenerative medicine.(4) The secretome includes a range of bioactive molecules contributing to tissue
remodeling, immune modulation, and angiogenesis. Bioactive molecules conveyed through a
secretome regulate various phases of the cell. Therefore, the research aims to characterize the effects
of Umbilical Cord-MSC (UC-MSC) secretomes on sperm quality in male asthenoteratozoospermia via
measures of Reactive Oxygen Species (ROS) levels, anti-oxidant enzyme activity, and sperm
parameters cell by transferring bioactive molecules.(6) Thus, the research goal is to investigate the
impact of UC-MSC secretomes on sperm quality in male asthenoterazoospermia using indicators of
ROS levels, activities of anti-oxidant enzymes, and sperm parameters.
This research evaluates the effects of UC-MSC-derived secretomes on sperm motility, concentration,
and morphology. Secondary objectives involve determining ROS levels and anti-oxidant enzyme
activity changes in sperm after exposure to secretomes, characterization of the molecular composition
of UCMSC-derived secretomes, defining mechanisms of interaction with sperm cells, and
understanding how UC-MSC-derived secretomes affect sperm function. The study hypothesizes that
UC-MSC-derived secretomes will reduce ROS levels, enhance anti-oxidant enzyme activity, and
improve sperm quality parameters in individuals with asthenoteratozoospermia.
MATERIALS AND METHODS
This study is an experimental study with a pre-post-test design. This design refers to a previous study
by von Schwarz et al. which used stem cell injections in erectile dysfunction patients. This study was
an experimental study with a pre-post-test research design with 12 subjects of severe ED non-
responsive to sildenafil. The study involved men aged 40-65 years with severe erectile dysfunction
unresponsive to sildenafil therapy, and samples were taken using a consecutive sampling technique.
The safety parameters measured included pain, hematoma, local bleeding, and infection. Efficacy
parameters were measured through the IIEF-5 questionnaire, EHS, morning erection, SPL, FPL, penis
circumference, and several ED evaluation examinations by PDCU. Color Doppler ultrasonography is
an informative and minimally invasive tool useful in the diagnosis and evaluation of erectile
dysfunction, especially in the evaluation of penile hemodynamics. Spectral Doppler analysis of the
cavernosal arteries in the flaccid penis is a non-invasive method for assessing arterial disease and has
been reported to have the best accuracy for predicting arterial insufficiency using a PSV cutoff value
of 10cm/s in the cavernosal arteries.