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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07431008

Acronym

Cellgram-ED

Enrollment

Registered

2026-02-24

Start date

2024-12-26

Completion date

2030-01-10

Last updated

2026-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Erectile Dysfunction

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

19 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Serious Adverse Events	From enrollment in the long-term follow-up study through 5 years of follow-up.	The number of participants experiencing serious adverse events during the safety follow-up period.
New Cancer Development	From enrollment in the long-term follow-up study through 5 years of follow-up.	The number of participants with newly diagnosed malignancies during the safety follow-up period.
Prostate Cancer Recurrence	From enrollment in the long-term follow-up study through 5 years of follow-up.	The number of participants with recurrence of prostate cancer during the safety follow-up period.
Tumor Marker Levels	Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.	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.

Countries

South Korea

Contacts

CONTACTdaeun jung

daeun4100@pharmicell.com82-2-3496-0134

PRINCIPAL_INVESTIGATORBumjin Lim, Ph.D

AIDS Malignancy Consortium

Outcome results