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The Outcomes of Intracavernosal Umbilical Cord Mesenchymal Stem Cells Implantation in Patients With Diabetic Erectile Dysfunction

NCT04972890 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2022-03-31

No results posted yet for this study

Summary

Erectile dysfunction (ED) is a complex condition affecting men worldwide. Diabetes mellitus (DM) is one of the most common causes of ED. The prevalence of ED in DM varies around 35-85%. Recently, stem cell therapy has started to become the focus of experimental and clinical studies for the treatment of ED. Stem cells have been shown to be able to regenerate functionally damaged tissue, depending on the stimuli or signals received. Stem cells studies in experimental animals have been carried out using biomarker parameters, including VEGF, Bcl-2, E-selectin, cGMP, eNOS and have been shown to be successful in increasing cell survival and angiogenesis, stimulating antiapoptotic, proneurogenic, proinflammatory, and antifibrotic effects and improvements to these biomarker parameters. This study aims to determine the efficacy, mechanism of action, and safety of umbilical cord mesenchymal stem cells as a therapy for ED due to type 2 diabetes in human.

Conditions

  • Urologic Diseases
  • Erectile Dysfunction With Diabetes Mellitus

Interventions

BIOLOGICAL

stem cells

Using umbilical cord stem cells 15x10\^6 cells in 2 cc saline/NaCl 0,9% solution

OTHER

placebo

using 2 cc saline/NaCl 0,9% solution

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-27
Primary Completion
2022-12-31
Completion
2023-01-31

Countries

  • Indonesia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04972890 on ClinicalTrials.gov