This phase II clinical trial with safety follow-up is designed to evaluate the efficacy and safety of Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) administered via intracavernous injection in patients with erectile dysfunction after radical prostatectomy.
Eligibility
Sex
MALE
Min age
19 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
* Participants who previously participated in the parent clinical trial and received the cell therapy (Cellgram-ED).
* Participants who have provided written informed consent to participate in this safety follow-up study.
Exclusion Criteria:
Primary outcome measure(s)
Tumor Marker Levels — Baseline and annually for up to 5 years after enrollment in the long-term follow-up study. Long-term safety will be evaluated by assessing changes in tumor marker levels including prostate-specific antigen (PSA), alpha-fetoprotein (AFP), and carcinoembryonic antigen (CEA) during the safety follow-up period.
Serious Adverse Events — From enrollment in the long-term follow-up study through 5 years of follow-up. The number of participants experiencing serious adverse events during the safety follow-up period.
New Cancer Development — From enrollment in the long-term follow-up study through 5 years of follow-up. The number of participants with newly diagnosed malignancies during the safety follow-up period.
Prostate Cancer Recurrence — From enrollment in the long-term follow-up study through 5 years of follow-up. The number of participants with recurrence of prostate cancer during the safety follow-up period.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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