Erectile Dysfunction Treatment Using Stem Cells

NCT ID: NCT06550752

Last Updated: 2024-08-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-10

Study Completion Date

2024-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Erectile Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

UC-MSCs and PRP

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* male patient with erectile dysfunction

Exclusion Criteria

* undergo other treatments for erectile dysfunction
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

COR clinic of Regenerative Medicine

NETWORK

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nada Alaaeddine

Dean of health Sciences at MUBS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nada Alaaeddine, PhD

Role: PRINCIPAL_INVESTIGATOR

COR clinic for Regenerative Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

COR clinic for Regenerative Medicine

Beirut, , Lebanon

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Lebanon

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nada Alaaeddine, PhD

Role: CONTACT

+9621426926 ext. 119

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nada Alaaeddine, PhD

Role: primary

+9611426926

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

S2024-cor002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.