Long-term safety follow-up of Cellgram-ED for erectile dysfunction after prostate removal
Official title: A Safety Follow-up Study of a Phase 2 Clinical Trial Evaluating the Efficacy and Safety of Cellgram-ED (Autologous Bone Marrow-Derived Mesenchymal Stem Cells) in Patients With Post-Radical Prostatectomy Erectile Dysfunction
Run by Pharmicell Co., Ltd. · NCT07431008 · Data updated 2026-11-12
This follow-up will see if Cellgram-ED—your own bone marrow stem cells given into the penis—remains safe over several years for men with erectile dysfunction after radical prostatectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years to 80 Years |
| Sex | Men only |
| Enrollment | 32 (estimated) |
| Sponsor | Pharmicell Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Seoul and 3 other locations) |
| Status | Recruiting |
| Started | December 26, 2024 |
| Main results expected | January 10, 2030 |
| Study ends | January 10, 2030 |
| Registry record updated | February 24, 2026 |
| Trial ID | NCT07431008 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are men who previously received Cellgram-ED in the parent trial for post‑prostatectomy erectile dysfunction and who are willing to provide informed consent for long‑term safety monitoring.
✕Probably not a fit
Patients who did not receive Cellgram-ED in the parent trial or who cannot attend scheduled follow-up visits are unlikely to gain direct benefit from this safety follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational follow-up enrolls participants who previously received Cellgram-ED (autologous bone marrow‑derived mesenchymal stem cells) via intracavernous injection in a parent phase II trial. No new experimental treatments are given; participants undergo scheduled safety checks over a 4‑year period (±30 days) from the parent trial completion. Study staff will monitor adverse events, serious adverse events, and other clinically relevant safety parameters to define the long‑term safety profile. Participation requires prior receipt of Cellgram‑ED and written informed consent for continued monitoring.
Why it matters
Potential benefit: If long-term safety is demonstrated, this could support using Cellgram-ED as a treatment option for erectile dysfunction after prostatectomy with an acceptable risk profile.
How similar studies have gone: Early-phase studies of intracavernosal mesenchymal stem cell therapy have shown preliminary improvements in erectile function, but long‑term safety data are limited, so this follow-up addresses a relatively novel evidence gap.
Who can join: the full rules
Show full inclusion / exclusion criteria
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:
Where it's running
-
Asan medical center
Seoul, South Korea Recruiting -
Ewha womans university medical center
Seoul, South Korea Recruiting -
Samsung medical center
Seoul, South Korea Recruiting -
Seoul ST. Mary's hospital
Seoul, South Korea Recruiting
Study contacts
- Principal investigator: Bumjin Lim, Ph.D — AIDS Malignancy Consortium
- Study coordinator: daeun jung
- Email: daeun4100@pharmicell.com
- Phone: 82-2-3496-0134
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.