Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction
Safety and Efficiacy of Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction: A Randomized Placebo-Controlled Clinical Trial
2 other identifiers
interventional
90
1 country
1
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) 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. Although many patients respond to standard pharmacological treatments, diabetic patients often demonstrate reduced responsiveness to these therapies. Regenerative medicine approaches, including stem cell therapy and stem cell-derived exosomes, have emerged as potential therapeutic strategies due to their regenerative, angiogenic, neuroprotective, and anti-fibrotic effects. The main questions this study aims to answer are:
- Whether intracavernosal administration of mesenchymal stem cells or MSC-derived exosomes improves erectile function, as measured by changes in the International Index of Erectile Function-5 (IIEF-5) and Erectile Hardness Score (EHS).
- Whether penile hemodynamics improve following treatment, as assessed by penile Doppler ultrasonography parameters including peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI). Participants will be randomly assigned to one of three groups:
- Intracavernosal placebo injection
- Intracavernosal injection of umbilical cord-derived mesenchymal stem cells (5×10⁶ cells)
- Intracavernosal injection of umbilical cord-derived mesenchymal stem cell-derived exosomes (75 μg) All interventions will be administered as a single intracavernosal injection under controlled clinical conditions. Participants will undergo baseline evaluation including medical history, physical examination, erectile function assessment using the IIEF-5 questionnaire, and penile Doppler ultrasonography. Follow-up evaluations will be conducted at 1, 3, 6, and 12 months after treatment to assess changes in erectile function, penile vascular parameters, and treatment-related adverse events. The study will also monitor potential side effects such as pain, bruising, hematoma, edema, or other complications related to the intracavernosal injection procedure. Participants will be recruited from patients presenting to the urology outpatient clinic with diabetic erectile dysfunction. Eligible participants must have a diagnosis of erectile dysfunction for at least six months, a history of diabetes mellitus for at least five years, and insufficient response to standard medical therapy. Patients with penile anatomical deformities, active infections, malignancy, unstable cardiovascular disease, autoimmune disease, or other contraindications to intracavernosal treatment will be excluded.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 29, 2025
CompletedFirst Submitted
Initial submission to the registry
March 7, 2026
CompletedFirst Posted
Study publicly available on registry
March 18, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 29, 2028
March 18, 2026
March 1, 2026
2 years
March 7, 2026
March 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (3)
Peak Systolic Velocity (PSV) as Measured by Penile Doppler Ultrasonography
Baseline, 3 months, and 12 months
End-Diastolic Velocity (EDV) as Measured by Penile Doppler Ultrasonography
Baseline, 3 months, and 12 months
Resistive Index (RI) as Measured by Penile Doppler Ultrasonography
Baseline, 3 months, and 12 months
Other Outcomes (1)
Treatment-Related Adverse Events and Complications
Up to 12 months
Study Arms (3)
Mesenchymal Stem Cell Treatment Group
EXPERIMENTALParticipants 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.
Exosome Treatment Group
EXPERIMENTALParticipants 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.
Placebo Control Group
PLACEBO COMPARATORParticipants 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.
Interventions
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.
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.
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.
Eligibility Criteria
You may qualify 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
- Ability and willingness to provide written informed consent
You may not qualify 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
- History of malignancy
- Autoimmune disease
- Use of immunosuppressive therapy
- Presence of systemic or local infection
- Uncontrolled diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara Bilkent City Hospital
Ankara, Ankara, 06800, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Samet Senel, MD, Associate Professor
Ankara City Hospital Bilkent
- STUDY DIRECTOR
Erkan Olcucuoglu, MD, Associate Professor
Ankara City Hospital Bilkent
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Urology
Study Record Dates
First Submitted
March 7, 2026
First Posted
March 18, 2026
Study Start
December 29, 2025
Primary Completion (Estimated)
December 29, 2027
Study Completion (Estimated)
December 29, 2028
Last Updated
March 18, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will become available after publication of the study results and will remain available for up to 3 years following publication.
- Access Criteria
- Eligible Users Access to individual participant data (IPD) will be granted to qualified researchers, academic institutions, and regulatory authorities with a legitimate scientific interest in the study data, particularly those conducting research related to erectile dysfunction, regenerative medicine, mesenchymal stem cell therapy, or exosome-based therapies.
Demographic Information De-identified demographic characteristics of participants, including age and relevant medical history. Baseline Assessments Baseline erectile function assessments including the International Index of Erectile Function-5 (IIEF-5) score and Erectile Hardness Score (EHS), as well as penile Doppler ultrasonography parameters such as peak systolic velocity (PSV), end-diastolic velocity (EDV), and resistive index (RI). Treatment Data Information regarding treatment allocation and intervention details, including intracavernosal administration of placebo, umbilical cord-derived mesenchymal stem cells (5×10⁶ cells), or mesenchymal stem cell-derived exosomes (75 μg). Follow-Up Data Outcome data collected during follow-up visits at 1, 3, 6, and 12 months, including changes in IIEF-5 scores, EHS scores, and penile Doppler ultrasonography measurements.