Clinical trial NCT06839651: Umbilical Cord Mesenchymal Stem Cell Secretome in Severe Erectile Dysfunction Non-responsive to Sildenafil
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Erectile Dysfunctions
Keywords: Erectile dysfunction
secretome
UC-MSC
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 10
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Visual analog scale
timeFrame: one hour and one year
measure: Hematomes
timeFrame: one hour
measure: Bleeding
timeFrame: one hour
measure: Erection hardness score
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: