Condition: Erectile Dysfunction With Diabetes Mellitus · Sponsor: Ankara City Hospital Bilkent
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 resist…
This description comes directly from the study's public registry record.
Samet Senel, MD, Associate Professor · +90 537 880 22 85 · samet_senel_umt@hotmail.com
Erkan Olcucuoglu, MD, Associate Professor · +90 505 517 04 98 · erkan.olcucuoglu@saglik.gov.tr
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| Ankara Bilkent City Hospital | Ankara, Ankara, Turkey (Türkiye) | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07480161