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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
this trial studies the erectile dysfunction in male patients
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nada Alaaeddine, PhD | Contact | +9621426926 | 119 | nalaaeddine@mubs.edu.lb |
| Name | Affiliation | Role |
|---|---|---|
| Nada Alaaeddine, PhD | COR clinic for Regenerative Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| COR clinic for Regenerative Medicine | Beirut | 0000 | Lebanon |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |