NCT07431008

Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 32 (estimated)
• Sponsor: Pharmicell Co., Ltd. · Industry
• Sex: Male
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Erectile Dysfunction

Timeline

• Start date: 2024-12-26
• Primary completion: 2030-01-10
• Completion: 2030-01-10
• First posted: 2026-02-24
• Last updated: 2026-02-24

Locations

4 sites across 1 country: South Korea