Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Erectile Dysfunction. Basic parameters: 19 years — 80 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Primary outcome measures
- Tumor Marker Levels [Time frame: 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.]
- New Cancer Development [Time frame: 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
South Korea · 4 centers
- Asan medical center — Seoul
- Ewha womans university medical center — Seoul
- Samsung medical center — Seoul
- Seoul ST. Mary's hospital — Seoul
Identifiers
NCT: NCT07431008 · PMC-P-10-01