Erectile Dysfunction Treatment Using Stem Cells

NCT06550752 | Not Yet Recruiting Phase 1

• 1 other identifier: S2024-cor002
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse effects

  Directly after the injection and after two weeks

Study Arms (1)

Mixture UC-MSCs and PRP

EXPERIMENTAL

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

Interventions

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.

Mixture UC-MSCs and PRP

Eligibility Criteria

• Gender Eligibility Details: this trial studies the erectile dysfunction in male patients
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• male patient with erectile dysfunction

You may not qualify if:

• undergo other treatments for erectile dysfunction

Sponsors & Collaborators

• COR clinic of Regenerative Medicine: lead

Study Sites (1)

COR clinic for Regenerative Medicine

Beirut, 0000, Lebanon

Location

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

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

Study Officials

• Nada Alaaeddine, PhD

  COR clinic for Regenerative Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nada Alaaeddine, PhD

CONTACT

+9621426926; nalaaeddine@mubs.edu.lb

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of health Sciences at MUBS

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: August 13, 2024
• Study Start: August 10, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 30, 2024
• Last Updated: August 13, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

LE (1)