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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cellgram-ED Safety Follow-up Group | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | From enrollment in the long-term follow-up study through 5 years of follow-up. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| daeun jung | Contact | 82-2-3496-0134 | daeun4100@pharmicell.com |
| Name | Affiliation | Role |
|---|---|---|
| Bumjin Lim, Ph.D | AIDS Malignancy Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Asan medical center | Recruiting | Seoul | South Korea |
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| ID | Term |
|---|---|
| D007172 | Erectile Dysfunction |
| ID | Term |
|---|---|
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D012735 | Sexual Dysfunction, Physiological |
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| Ewha womans university medical center | Recruiting | Seoul | South Korea |
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| Samsung medical center | Recruiting | Seoul | South Korea |
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| Seoul ST. Mary's hospital | Recruiting | Seoul | South Korea |
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| D052801 | Male Urogenital Diseases |
| D020018 | Sexual Dysfunctions, Psychological |
| D001523 | Mental Disorders |