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Clinical Trial NCT07480161 for Erectile Dysfunction With Diabetes Mellitus is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction Phase 2, Phase 3 90 Cell Therapy Randomized International

Recruiting
Clinical Trial NCT07480161 is designed to study Treatment for Erectile Dysfunction With Diabetes Mellitus. It is a Phase 2 Phase 3 interventional study that is recruiting, having started on 29 December 2025, with plans to enroll 90 participants. Led by Ankara City Hospital Bilkent, it is expected to complete by 29 December 2028. The latest data from ClinicalTrials.gov was last updated on 18 March 2026.
Brief Summary
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)...Show More
Detailed Description
Detailed Description This prospective randomized controlled clinical study is designed to evaluate the safety and efficacy of intracavernosal injections of umbilical cord-derived mesenchymal stem cells (MSCs) and MSC-derived exosomes in men with diabetic erectile dysfunction (ED) who have not responded adequately to conventional medical treatments such as phosphodiesterase type-5 (PDE-5) inhibitors. The study will co...Show More
Official Title

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

Conditions
Erectile Dysfunction With Diabetes Mellitus
Other Study IDs
  • SEK-ED001
  • E2-25-13291 (Other Identifier) (Ankara Bilkent City Hospital Clinical Research Ethics Committee)
NCT ID Number
NCT07480161
Start Date (Actual)
2025-12-29
Last Update Posted
2026-03-18
Completion Date (Estimated)
2028-12-29
Enrollment (Estimated)
90
Study Type
Interventional
PHASE
Phase 2
Phase 3
Status
Recruiting
Keywords
Diabetic Erectile Dysfunction
Mesenchymal Stem Cells
Stem Cell Therapy
Exosome Therapy
Intracavernosal Injection
Regenerative Medicine
Cell-Based Therapy
Erectile dysfunction
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalMesenchymal Stem Cell Treatment Group
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 ...Show More
Umbilical Cord-Derived Mesenchymal Stem Cells
Intracavernosal injection of 5×10⁶ umbilical cord-derived mesenchymal stem cells (MSCs) produced under Good Manufacturing Practice (GMP) conditions. The cells are administered directly into the corpus cavernosum to promote tissue regeneration, angiogenesis, and improvement of erectile function in patients with diabetic erectile dysfunction.
ExperimentalExosome Treatment Group
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.
Umblical Cord-Derived Mesenchymal Stem Cell-Derived Exosomes
Intracavernosal injection of 75 μg mesenchymal stem cell-derived exosomes obtained from cultured umblical cord-derived mesenchymal stem cells. Exosomes are extracellular vesicles containing bioactive molecules that may stimulate angiogenesis, tissue repair, and vascular regeneration in erectile tissue.
Placebo ComparatorPlacebo Control Group
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.
Placebo Intracavernosal Injection
Intracavernosal injection of sterile 0.9% sodium chloride solution administered as placebo. The injection procedure will be identical to the treatment groups to maintain study blinding.
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Change in Erectile Function as Measured by the International Index of Erectile Function-5 (IIEF-5) Score
The primary outcome measure is the change in erectile function assessed by the International Index of Erectile Function-5 (IIEF-5). The IIEF-5 is a validated questionnaire widely used to evaluate erectile function in men with erectile dysfunction. The score ranges from 5 to 25, with higher scores indicating better erectile function. Participants will complete the questionnaire at baseline and during follow-up visits. The study aims to determine whether intracavernosal injection of mesenchymal stem cells or mesenchymal stem cell-derived exosomes improves erectile function compared with placebo.
Baseline, 1 month, 3 months, 6 months, and 12 months
Change in Erectile Hardness Score (EHS)
Erectile rigidity will be evaluated using the Erectile Hardness Score (EHS). EHS is a validated single-item scale ranging from 0 to 4, where higher scores indicate greater erectile rigidity. Changes in EHS from baseline will be analyzed to assess improvement in erectile function following treatment.
Baseline, 1 month, 3 months, 6 months, and 12 months
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Peak Systolic Velocity (PSV) as Measured by Penile Doppler Ultrasonography
Peak systolic velocity (PSV) measured by penile Doppler ultrasonography will be used to assess arterial blood flow in the penile cavernosal arteries following treatment with mesenchymal stem cells or stem cell-derived exosomes.
Baseline, 3 months, and 12 months
End-Diastolic Velocity (EDV) as Measured by Penile Doppler Ultrasonography
End-diastolic velocity (EDV) measured by penile Doppler ultrasonography will be used to assess veno-occlusive function following treatment with mesenchymal stem cells or stem cell-derived exosomes.
Baseline, 3 months, and 12 months
Resistive Index (RI) as Measured by Penile Doppler Ultrasonography
Resistive index (RI) measured by penile Doppler ultrasonography will be used to evaluate penile vascular resistance following treatment with mesenchymal stem cells or stem cell-derived exosomes.
Baseline, 3 months, and 12 months
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
25 Years
Eligible Sexes
Male
  • 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
Ankara City Hospital Bilkent logoAnkara City Hospital Bilkent
Study Responsible Party
Samet Şenel, Principal Investigator, Associate Professor of Urology, Ankara City Hospital Bilkent
Study Central Contact
Contact: Samet Senel, MD, Associate Professor, +90 537 880 22 85, [email protected]
Contact: Erkan Olcucuoglu, MD, Associate Professor, +90 505 517 04 98, [email protected]
1 Study Locations in 1 Countries

Ankara

Ankara Bilkent City Hospital, Ankara, Ankara, 06800, Turkey (Türkiye)
Samet Senel, MD, Associate Professor, Contact, +90 537 880 22 85, [email protected]
Erken Olcucuoglu, MD, Associate Professor, Contact, +90 505 517 04 98, [email protected]
Recruiting