Erectile Dysfunction Treatment Using Stem Cells

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Erectile Dysfunction
• Intervention / Treatment: Combination product: UC-MSCs and PRP

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Nada Alaaeddine, PhD; Phone Number: 119 +9621426926; Email: nalaaeddine@mubs.edu.lb

Study Locations

• Lebanon
  • Beirut, Lebanon, 0000
    • COR clinic for Regenerative Medicine
    • Contact: Nada Alaaeddine, PhD; Phone Number: +9611426926; Email: cormedicine17@gmail.com
    • Sub-Investigator: Abbas Khadra, Urologist

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• male patient with erectile dysfunction

Exclusion Criteria:

• undergo other treatments for erectile dysfunction

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mixture UC-MSCs and PRP; A mixture of UCSCs and PRP will be injected into the corpora cavernosa of the penis of each patient. The injection will be done at four points along the shaft on both sides of the penis. The injection procedure will be performed once per month for a total duration of three months. Each patient received a dosage of 10 million cells per injection session.

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. 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Penile Doppler ultrasonography for assessment of erectile function	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.	before treatment and after 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse effects	patients will be asked to report any adverse effects related to the injected product or procedure	Directly after the injection and after two weeks

Collaborators and Investigators

• Sponsor: COR clinic of Regenerative Medicine
• Investigators: Principal Investigator: Nada Alaaeddine, PhD, COR clinic for Regenerative Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): August 10, 2024
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 5, 2024
• First Submitted That Met QC Criteria: August 8, 2024
• First Posted (Actual): August 13, 2024

Study Record Updates

• Last Update Posted (Actual): August 13, 2024
• Last Update Submitted That Met QC Criteria: August 8, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Erectile Dysfunction
• Other Study ID Numbers: S2024-cor002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No