Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction
ConditionErectile Dysfunction
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age19-80
SponsorPharmicell Co., Ltd.
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
32 Participants
are grouped into 1 trial groupGroup A: Cellgram-ED Safety Follow-up Group
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.2
Serious Adverse Events
The number of participants experiencing serious adverse events during the safety follow-up period.
Time frame
From enrollment in the long-term follow-up study through 5 years of follow-up.3
New Cancer Development
The number of participants with newly diagnosed malignancies during the safety follow-up period.
Time frame
From enrollment in the long-term follow-up study through 5 years of follow-up.4
Prostate Cancer Recurrence
The number of participants with recurrence of prostate cancer during the safety follow-up period.
Time frame
From enrollment in the long-term follow-up study through 5 years of follow-up.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov