Erectile DysfunctionCellgram-EDNCT07431008
Safety Follow-up Study of Cellgram-ED in Post-Radical Prostatectomy Erectile Dysfunction
An observational study of Erectile Dysfunction, run by Pharmicell Co., Ltd. at 4 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, men only
- Conditions the study is for
- Erectile Dysfunction
- Type of treatment
- Injection or infusion
- How many people
- 32 participants
- Where
- 4 sitesSouth Korea
- Study dates
- 26 Dec 2024to 10 Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
None listed.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea4 sites, 4 recruiting
- Recruiting
Asan medical center
Seoul
Bumjin Im, 82-2-3010-1835, lbj1986@hanmail.net
- Recruiting
Ewha womans university medical center
Seoul
Kim Chungsu, 82-10-2297-3734, cskim37345806@gmail.com
- Recruiting
Samsung medical center
Seoul
Deokhyun Han, 82-2-3410-6431, deokhyun.han@gmail.com
- Recruiting
Seoul ST. Mary's hospital
Seoul
Jiyoul Lee, 82-2-2258-6227, uroljy@catholic.ac.kr
About this study
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
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.
Read the 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.
- Conditions
- Erectile Dysfunction
- Medical subject headings
- Erectile Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment in the long-term follow-up study through 5 years of follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start26 Dec 2024
- Primary completion10 Jan 2030 (estimated)
- Study completion10 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pharmicell Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bumjin Lim, Ph.D, Principal investigator, AIDS Malignancy Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431008
- Sponsor's protocol ID
- PMC-P-10-01
- Acronym
- Cellgram-ED
- Status last verified
- Feb 2026
- First submitted
- 9 Feb 2026
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07431008
- Acronym / sponsor ID
- Cellgram-ED / PMC-P-10-01
- Conditions
- Erectile Dysfunction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Pharmicell Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Dec 2024 (actual)
- Primary completion
- 10 Jan 2030 (estimated)
- Study completion
- 10 Jan 2030 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bumjin Lim, Ph.D principal investigator
AIDS Malignancy Consortium
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Erectile Dysfunction, run by Pharmicell Co., Ltd. at 4 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact daeun jung (82-2-3496-0134, daeun4100@pharmicell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor Marker Levels (time frame: Baseline and annually for up to 5 years after enrollment in the long-term follow-up study.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.