Recruiting

Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction

Study Aim

This study aims to evaluate the effectiveness of mesenchymal stem cell and exosome therapy in improving erectile function in men with diabetic erectile dysfunction, as measured by the International Index of Erectile Function-5 (IIEF-5) score and Erectile Hardness Score (EHS).

What is being tested

Umbilical Cord-Derived Mesenchymal Stem Cells

+ Umblical Cord-Derived Mesenchymal Stem Cell-Derived Exosomes

+ Placebo Intracavernosal Injection

Biological

Who is being recruted

Urogenital Diseases+5

+ Genital Diseases

+ Mental Disorders

From 25 to 75 Years

+17 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-ControlledPhase 2 & 3

Interventional

Study Start: December 2025

See protocol details

Summary

Principal SponsorAnkara City Hospital Bilkent

Study ContactSamet Senel, MD, Associate ProfessorMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: December 29, 2025

Actual date on which the first participant was enrolled.

This study focuses on men with diabetic erectile dysfunction who haven't responded well to conventional treatments like phosphodiesterase type-5 (PDE-5) inhibitors. The goal is to test the safety and effectiveness of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and MSC-derived exosomes. The hope is that these regenerative therapies can improve erectile function more than a placebo, helping men with this condition regain quality of life. During the study, participants will receive either the stem cell treatment, exosome treatment, or a placebo injection. The main measure of success is improvement in erectile function, as evaluated by the International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS). Penile hemodynamics will also be assessed using penile Doppler ultrasonography. Safety outcomes and any treatment-related adverse events will be closely monitored throughout the study period.

Official TitleSafety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial

NCT07480161

Principal SponsorAnkara City Hospital Bilkent

Study ContactSamet Senel, MD, Associate ProfessorMore contacts

Last updated: March 19, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Male

Biological sex of participants that are eligible to enroll.

From 25 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesGenital DiseasesMental DisordersGenital Diseases, MaleErectile DysfunctionSexual Dysfunction, PhysiologicalSexual Dysfunctions, PsychologicalMale Urogenital Diseases

Criteria

6 inclusion criteria required to participate

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

Show More Criteria

11 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Participants in this group will receive a single intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells). The stem cells are produced under Good Manufacturing Practice (GMP) conditions and administered directly into the corpus cavernosum. The treatment aims to improve erectile function by promoting angiogenesis, tissue regeneration, and improved penile vascular function. Participants will be followed for safety and efficacy outcomes during scheduled follow-up visits.

Group II

Experimental

Participants in this group will receive a single intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg). Exosomes are extracellular vesicles that contain growth factors and signaling molecules that may promote tissue repair and vascular regeneration. This cell-free regenerative therapy aims to improve erectile function in patients with diabetic erectile dysfunction.

Group III

Placebo

Participants in this group will receive a single intracavernosal injection of sterile normal saline (0.9% sodium chloride solution) as placebo. The placebo injection will be administered using the same procedure as the treatment groups in order to maintain study blinding. Participants will undergo the same follow-up assessments as the other study groups.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)Open Ankara Bilkent City Hospital in Google Maps

Recruiting

One Study Center