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

NCT06839651 | Not Yet Recruiting Phase 1

• 2 other identifiers: KET-1862/ETIK/PPM.00.02/2024PUTI Q1 Universitas Indonesia
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Erectile Dysfunctions

Keywords

Erectile dysfunction; secretome; UC-MSC

Outcome Measures

Primary Outcomes (4)

• Visual analog scale

  A visual analog scale is used for measuring pain. The patient will be asked to describe the pain on a scale of 1-10. Scale 1 means no pain and 10 means very great pain. A higher score indicates a worse outcome.

  one hour and one year

• Hematomes

  Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.

  one hour

• Bleeding

  Bleeding is one of the outcomes of the research. If there is a bleeding, it would be marked as 1; if there is no bleeding, it would be marked as 0.

  one hour

• Erection hardness score

  Rapid diagnostic tool to evaluate erectile dysfunction. There are 4 score; 1 indicates severe erectile dysfunction (Worst) and 4 indicates there is optimal erection. (Good)

  one year

Study Arms (1)

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

EXPERIMENTAL

postreatment group: severe eretile dysfunction non responsive Sildenafil with injection

Combination Product: uc-msc secretome intra cavernous injection

Interventions

uc-msc secretome intra cavernous injection 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.

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

Eligibility Criteria

• Age: 40 Years - 65 Years
• Gender Eligibility Details: Male patients with severe erectile dysfunction non-responsive sildenafil
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Central Study Contacts

Ria Margiana, M.D, PhD

CONTACT

+62 811-1775-515; ria.marrgiana11@gmail.com

Tania Graciana, M.D

CONTACT

+6285624458456; taniagraciana@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ria Margiana, MD, M.Biomed, PhD

Study Record Dates

• First Submitted: February 10, 2025
• First Posted: February 21, 2025
• Study Start: April 21, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 25, 2025

Record last verified: 2025-02