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

University of Indonesia (UI)

Status and phase

Not yet enrolling

Phase 1

Conditions

Erectile Dysfunctions

Treatments

Combination Product: uc-msc secretome intra cavernous injection

Study type

Interventional

Funder types

Other

Identifiers

NCT06839651

KET-1862/ETIK/PPM.00.02/2024

PUTI Q1 Universitas Indonesia (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 estimated patients

Sex

Male

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

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).