Menu
Not yet recruiting NCT06839651

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

Phase I Interventional Erectile Dysfunctions

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: uc-msc secretome intra cavernous injection.
Who it may be relevant to
Registry conditions: Erectile Dysfunctions. Basic parameters: 40 years — 65 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • 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 region

Primary outcome measures

  • Visual analog scale [Time frame: one hour and one year]
  • Hematomes [Time frame: one hour]
  • Bleeding [Time frame: one hour]
  • Erection hardness score [Time frame: one year]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06839651 · KET-1862/ETIK/PPM.00.02/2024 · PUTI Q1 Universitas Indonesia

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗