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Not yet recruiting NCT06550752

Erectile Dysfunction Treatment Using Stem Cells

Phase I / Phase II Interventional Erectile Dysfunction

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-MSCs and PRP.
Who it may be relevant to
Registry conditions: Erectile Dysfunction. Basic parameters: No limits · 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
Lebanon
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Intracavernous Injection of Umbilical Cord Stem Cells and Platelet-Rich Plasma for the Treatment of Erectile Dysfunction

Overview

A prospective clinical study to investigate the safety and efficacy of intracavernosal injections of umbilical cord stem cells (UCSCs) combined with platelet-rich plasma (PRP) for erectile dysfunction

Detailed description

Umbilical cord mesenchymal stem cells (UC-MSCs) combined with platelet-rich plasma (PRP) will be injected into the corpora cavernosa of the penis of male patients with erectile dysfunction. The injection will be done at four points along the shaft on both sides of the penis. Penile Doppler ultrasonography will be performed on all patients before the initiation of the treatment. This assessment will be conducted to establish a baseline measurement of penile blood flow in both left and right sides of the penis. Subsequently, after four months of treatment, penile duplex Doppler ultrasonography will be repeated to compare the penile doppler before and after treatment. Statistical analyses will be performed using IBM SPSS Statistics for Windows, version 26.

Interventions

  • Combination product UC-MSCs and PRP
    UC-MSCs are progenitor cells that can differentiate into various types of cells in the body and have the ability to regenerate and repair damaged tissue. During repair and regeneration, these cells secrete expedient and powerful bioactive paracrine factors including cytokines, chemokines, collagen, fibronectin, and growth factors promoting tissue repair, angiogenesis, and the regeneration of nerve cells as well as regulating cellular pathways including immunomodulation and inflammatory responses

Primary outcome measures

  • Penile Doppler ultrasonography for assessment of erectile function [Time frame: before treatment and after 4 months]
Secondary outcome measures (1)
  • Adverse effects [Time frame: Directly after the injection and after two weeks]

Eligibility criteria

Inclusion criteria

  • male patient with erectile dysfunction

Exclusion criteria

  • undergo other treatments for erectile dysfunction

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

Lebanon · 1 center
  • COR clinic for Regenerative Medicine — Beirut

Identifiers

NCT: NCT06550752 · S2024-cor002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗