Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06550752

Erectile Dysfunction Treatment Using Stem Cells

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

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

COR clinic for Regenerative Medicine

Beirut, 0000, Lebanon

Location contact

Abbas Khadra, Urologist

SUB_INVESTIGATOR

Nada Alaaeddine, PhD

CONTACT

[email protected]

+9611426926

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • male patient with erectile dysfunction

Exclusion criteria

  • undergo other treatments for erectile dysfunction

Treatment and study plan

UC-MSCs and PRP

Combination Product

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. Additionally, PRP contains numerous growth factors and cytokines, including vascular endothelial growth factor (VEGF), transforming growth factor beta-1 and beta-2 (TGF-β1/2), platelet-derived growth factor (PDGF), insulin-like growth factor (IGF), interleukin 8 and matrix metalloproteinases 2,9. The combined effect of these factors provided by PRP injections is proposed to have anti- inflammatory, reparative, neuroprotective and neurotrophic effects that contribute to the treatment of ED.

Primary outcomes

  1. Penile Doppler ultrasonography for assessment of erectile function

    Time frame: before treatment and after 4 months

    Penile Doppler ultrasonography will be used to evaluate erectile function by measuring peak systolic velocity (PSV) in the penile arteries. This parameter will be assessed before the initiation of the treatment and after 4 months of treatment to evaluate blood flow in the penile arteries. The primary outcome will focus on changes in PSV, which will be compared between the baseline and post-treatment assessments to determine the efficacy of the intervention.

Secondary outcomes

  1. Adverse effects

    Time frame: Directly after the injection and after two weeks

    patients will be asked to report any adverse effects related to the injected product or procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Nada Alaaeddine, PhD

CONTACT

[email protected]

+9621426926 ext. 119

Sponsors and collaborators

Lead sponsor

COR clinic of Regenerative Medicine

Network

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 13, 2024
Registry last updated
Aug 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.