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New treatment option for Erectile Dysfunction With Diabetes Mellitus
Official title Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction
ClinicalTrials.gov ID: NCT07480161
What this study is testing
What is Umbilical Cord-Derived Mesenchymal Stem Cells?
Umbilical Cord-Derived Mesenchymal Stem Cells is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for erectile dysfunction with diabetes mellitus.
Also referred to as Mesenchymal Stem Cell Therapy, MSC Injection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of this prospective randomized controlled clinical study is to evaluate the effectiveness and safety of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and umbilical cord-derived MSC-derived exosomes in men aged 25 to 75 years with diabetic erectile dysfunction (ED) who have not responded adequately to conventional medical treatments such as phosphodiesterase type-5 (PDE-5) inhibitors. Diabetes mellitus is a major risk factor for erectile dysfunction and is associated with endothelial dysfunction, impaired smooth muscle relaxation, neuropathy, and increased fibrosis within penile tissue.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 25 to 75, men only
You may be able to join if
- Male patients aged 25 to 75 years
- Diagnosis of erectile dysfunction for at least 6 months
- Type 1 or Type 2 diabetes mellitus for at least 5 years
- Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and/or intracavernosal prostaglandin E1 therapy
- Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction
You likely can't join if
- Penile anatomical deformities
- Active infection or skin lesion on the penis
- Bleeding disorders or coagulation abnormalities
- Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery
- Untreated hypogonadism
- Unstable cardiovascular disease
See the full eligibility criteria
- Male patients aged 25 to 75 years
- Diagnosis of erectile dysfunction for at least 6 months
- Type 1 or Type 2 diabetes mellitus for at least 5 years
- Inadequate response to medical treatment, including phosphodiesterase type-5 (PDE-5) inhibitors and/or intracavernosal prostaglandin E1 therapy
- Candidates for penile prosthesis implantation due to treatment-resistant erectile dysfunction
- Ability and willingness to provide written informed consent
- Penile anatomical deformities
- Active infection or skin lesion on the penis
- Bleeding disorders or coagulation abnormalities
- Previous penile prosthesis implantation, penile vascular surgery, or pelvic surgery
- Untreated hypogonadism
- Unstable cardiovascular disease
- History of malignancy
- Autoimmune disease
- Use of immunosuppressive therapy
- Presence of systemic or local infection
- Uncontrolled diabetes mellitus
The study team makes the final eligibility decision.
Where it's taking place
- Ankara, Ankara, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling male, 25 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ankara, Ankara, Turkey (Türkiye). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.