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

February 24, 2025 updated by: Ria Margiana, Indonesia University

Analysis of the Safety and Efficacy of Administering Umbilical Cord Mesenchymal Stem Cell Secretome in Patients with Severe Erectile Dysfunction Non-responsive to Sildenafil

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pretreatment group: severe eretile dysfunction non responsive Sildenafil with no injection
postreatment group: severe eretile dysfunction non responsive Sildenafil with injection
Combination product: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analog scale
Time Frame: one hour and one year
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
Time Frame: one hour
Hematomes means blue discoloration. 0 scale means there is no discoloration and 1 means there is a discoloration.
one hour
Bleeding
Time Frame: one hour
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
Time Frame: one year
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Indonesia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 21, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

February 10, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KET-1862/ETIK/PPM.00.02/2024
  • PUTI Q1 Universitas Indonesia (Other Identifier: Universitas Indonesia)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Erectile Dysfunctions

Clinical Trials on uc-msc secretome intra cavernous injection

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe