Long-term safety follow-up of Cellgram-ED for erectile dysfunction after prostate removal
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
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 |
|---|---|
| Enrollment | 32 (estimated) |
| Ages | 19 Years to 80 Years |
| Sex | Male |
| Sponsor | Pharmicell Co., Ltd. Industry-sponsored |
| Locations | 4 sites (Seoul and 3 other locations) |
| Trial ID | NCT07431008 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul and 3 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.