Erectile Dysfunction Treatment Using Stem Cells
- Conditions
- Erectile Dysfunction
- Interventions
- Combination Product: UC-MSCs and PRP
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Male
- Target Recruitment
- 30
- male patient with erectile dysfunction
- undergo other treatments for erectile dysfunction
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Mixture UC-MSCs and PRP 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.
- 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