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

NCT ID: NCT06839651

Last Updated: 2025-02-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-21
• Study Completion Date: 2026-04-01

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.

Conditions

Erectile Dysfunctions

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection

postreatment group: severe eretile dysfunction non responsive Sildenafil with injection

Group Type: EXPERIMENTAL

uc-msc secretome intra cavernous injection

Intervention Type: COMBINATION_PRODUCT

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.

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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).

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Ria Margiana

Ria Margiana, MD, M.Biomed, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ria Margiana, M.D, PhD

Role: CONTACT

ria.marrgiana11@gmail.com

+62 811-1775-515

Tania Graciana, M.D

Role: CONTACT

taniagraciana@gmail.com

+6285624458456

Other Identifiers

PUTI Q1 Universitas Indonesia

Identifier Type: OTHER

Identifier Source: secondary_id

KET-1862/ETIK/PPM.00.02/2024

Identifier Type: -

Identifier Source: org_study_id