An observational study in Erectile Dysfunction, sponsored by Pharmicell Co., Ltd.. Recruiting at 4 sites in South Korea. Open to male participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Pharmicell Co., Ltd. · Observational
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.
Safety evaluations will be conducted over a period of 4 years (±30 days) from the completion date of the parent clinical trial. During the safety follow-up period, participants will be monitored for adverse events, serious adverse events, and other clinically relevant safety parameters to assess the long-term safety profile of Cellgram-ED.
701 studies on the registry are indexed under Erectile Dysfunction; 125 are open to participants now.
This study's planned enrollment of 32 is below the median of 130 across 125 observational studies indexed under Erectile Dysfunction.
Browse Erectile Dysfunction studies →Pharmicell Co., Ltd. is the lead sponsor of 18 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
This observational study includes patients who previously participated in the Phase 2 clinical trial of Cellgram-ED and received the investigational cell therapy. Eligible participants are those who completed the interventional study and provided written informed consent for long-term safety follow-up. No additional investigational treatment is administered as part of this study; data are collected solely for the assessment of long-term safety outcomes.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in this arm previously received Cellgram-ED (autologous bone marrow-derived mesenchymal stem cells) via intracavernous injection in the parent phase II clinical trial. This safety follow-up study monitors these participants for long-term safety outcomes for up to 4 years (±30 days) from the completion of the parent trial, including assessment of adverse events and other clinically relevant safety parameters.
Tumor Marker Levels
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.
Time frame: Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.
Serious Adverse Events
The number of participants experiencing serious adverse events during the safety follow-up period.
Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.
New Cancer Development
The number of participants with newly diagnosed malignancies during the safety follow-up period.
Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.
Prostate Cancer Recurrence
The number of participants with recurrence of prostate cancer during the safety follow-up period.
Time frame: From enrollment in the long-term follow-up study through 5 years of follow-up.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Pharmicell Co., Ltd.