Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-26 @ 3:14 PM
NCT ID:
NCT07480161
Description:
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.
Study:
NCT07480161
Study Brief:
Mesenchymal Stem Cell and Exosome Therapy for Diabetic Erectile Dysfunction