NCT07480161 Umbilical Cord-Derived Mesenchymal Stem Cells(Ankara City Hospital Bilkent) Erectile dysfunction due to diabetes mellitus Clinical Landscape Report 2026: Design, Endpoints, Sponsor and Readout Outlook

Turn a newly registered trial into a decision-ready clinical landscape. This report examines NCT07480161 using PatSnap Clinical Trials MCP for protocol design and endpoint evidence, with Drug & Asset MCP and Company & Deal Intelligence MCP used as the companion asset and sponsor enrichment workflow. Explore PatSnap MCP Servers to reproduce the research sequence inside an AI workflow.

MCP evidence snapshot: 24 August 2026. Trial records, recruitment status and projected dates can change after the snapshot and should be rechecked before operational decisions.

Why NCT07480161 is a hot trial to watch

Erectile dysfunction due to diabetes mellitus is being segmented by mechanism, treatment setting, geography and endpoint architecture. NCT07480161 is notable because it evaluates Umbilical Cord-Derived Mesenchymal Stem Cells(Ankara City Hospital Bilkent) in a Phase 2/3 design sponsored by Ankara Bilkent City Hospital. The main development question is whether the protocol can translate its rationale into a clinically interpretable and operationally credible readout.

Trial landscape snapshot

Protocol design and endpoint interpretation

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 regen

Allocation is Randomized, masking is Single, and the intervention model is Parallel Assignment. Planned enrollment of [object Object] participants across Turkey shapes statistical precision, execution risk and external validity. Interpretation should account for baseline risk, prior therapy, assessment schedule, missing-data handling and clinical relevance—not only statistical significance.

• Change in Erectile Function as Measured by the International Index of Erectile Function-5 (IIEF-5) Score (Baseline, 1 month, 3 months, 6 months, and 12 months) — 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.
• Change in Erectile Hardness Score (EHS) (Baseline, 1 month, 3 months, 6 months, and 12 months) — 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.

Readout outlook and evidence gap

The current protocol points to [object Object] as the best available readout proxy. Because this is an active or newly posted study, a trial-specific result citation is not included until a normalized clinical-trial-result record becomes available. That gap is itself operationally important: teams should monitor first result indexing, conference abstracts, protocol amendments and changes to the primary-completion date.

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Asset and sponsor context

Drug & Asset MCP profile: Umbilical Cord-Derived Mesenchymal Stem Cells(Ankara City Hospital Bilkent) is indexed as No normalized modality returned, with target No normalized target returned, mechanism No normalized mechanism returned, and global highest development status No normalized global status returned.

Company & Deal Intelligence MCP profile: Ankara Bilkent City Hospital is resolved to a normalized organization record in Turkey. The organization workflow adds identity, location, portfolio and partnering context where available.

The sponsor profile matters because scientific rationale alone does not determine development value. Manufacturing readiness, portfolio fit, geographic reach, partnering capacity and the ability to fund confirmatory development can determine whether a positive signal becomes a competitive asset.

White space around this program

• Sharper patient selection: prospective biomarker or phenotype definitions that identify who is most likely to benefit.
• Clinically interpretable endpoints: outcomes connecting activity with function, symptoms, survival or treatment burden.
• Comparator relevance: evidence against the most decision-relevant contemporary standard of care.
• Broader external validity: evidence across additional geographies, demographic groups and real-world settings.
• Operational differentiation: a development path that closes the readout gap without sacrificing safety or durability.

What to monitor next

Monitor recruitment, enrollment changes, protocol amendments, endpoint hierarchy, primary-completion timing, first result indexing, asset ownership and sponsor partnerships. A change in endpoint, population or ownership can alter the probability of success before a headline data release.

Bottom line

NCT07480161 provides a focused lens on Erectile dysfunction due to diabetes mellitus development. Its value will be determined by whether Umbilical Cord-Derived Mesenchymal Stem Cells(Ankara City Hospital Bilkent) can convert the current Phase 2/3 design into evidence that is clinically meaningful, operationally credible and differentiated from competing programs.

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