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

February 20, 2026 updated by: Pharmicell Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

32

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • South Korea
      • Seoul, South Korea
        • Recruiting
        • Samsung Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Asan Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Ewha Womans University Medical Center
        • Contact:
      • Seoul, South Korea
        • Recruiting
        • Seoul St. Mary'S Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor Marker Levels
Time Frame: 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.
Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.
Serious Adverse Events
Time Frame: 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.
From enrollment in the long-term follow-up study through 5 years of follow-up.
New Cancer Development
Time Frame: 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.
From enrollment in the long-term follow-up study through 5 years of follow-up.
Prostate Cancer Recurrence
Time Frame: 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.
From enrollment in the long-term follow-up study through 5 years of follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pharmicell Co., Ltd.

Investigators

  • Principal Investigator: Bumjin Lim, Ph.D, AIDS Malignancy Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 26, 2024

Primary Completion (Estimated)

January 10, 2030

Study Completion (Estimated)

January 10, 2030

Study Registration Dates

First Submitted

February 9, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 24, 2026

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 20, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMC-P-10-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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