Erectile Dysfunction Treatment Using Stem Cells

Phase 1

Not yet recruiting

• Conditions: Erectile Dysfunction

• Registration Number: NCT06550752
• Lead Sponsor: COR clinic of Regenerative Medicine

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

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 Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-05
• Study First Submitted QC: 2024-08-08
• Last Update Submitted: 2024-08-08
• Study Start: 2024-08-10
• Study First Posted: 2024-08-13
• Last Update Posted: 2024-08-13
• Primary Completion: 2024-10-01
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

• male patient with erectile dysfunction

Exclusion Criteria

• undergo other treatments for erectile dysfunction

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Penile Doppler ultrasonography for assessment of erectile function	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 Outcome Measures

Name	Time	Method
Adverse effects	Directly after the injection and after two weeks	patients will be asked to report any adverse effects related to the injected product or procedure

Trial Locations

Locations (1)

COR clinic for Regenerative Medicine; 🇱🇧 Beirut, Lebanon