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
Location: See all (4) locations...
Study Type: Observational
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.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Republic of Korea
Asan medical center
RECRUITING
Seoul
Ewha womans university medical center
RECRUITING
Seoul
Samsung medical center
RECRUITING
Seoul
Seoul ST. Mary's hospital
RECRUITING
Seoul
Contact Information
Primary
daeun jung
daeun4100@pharmicell.com
82-2-3496-0134
Time Frame
Start Date: 2024-12-26
Estimated Completion Date: 2030-01-10
Participants
Target number of participants: 32
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Pharmicell Co., Ltd.