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

NCT07431008 | Recruiting

• 1 other identifier: PMC-P-10-01
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 4

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.

Conditions

Erectile Dysfunction

Outcome Measures

Primary Outcomes (4)

• 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.

Study Arms (1)

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.

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• Pharmicell Co., Ltd.: lead

Study Sites (4)

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

MeSH Terms

Conditions

Erectile Dysfunction

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Bumjin Lim, Ph.D

  AIDS Malignancy Consortium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

daeun jung

CONTACT

82-2-3496-0134; daeun4100@pharmicell.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: February 24, 2026
• Study Start: December 26, 2024
• Primary Completion (Estimated): January 10, 2030
• Study Completion (Estimated): January 10, 2030
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

KR (4)