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Erectile DysfunctionPhase 2Cellgram-EDNCT04594850

Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Injected Intracavernously

A Phase 2 study testing Cellgram-ED in people with Erectile Dysfunction, run by Pharmicell Co., Ltd. at 4 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously. Read more about this study

Who is it for?
Ages 19 to 79 years, men only
Conditions the study is for
Erectile Dysfunction
What is being tested?
Cellgram-ED
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
4 sitesSouth Korea
Study dates
19 Oct 2020to 7 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

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 79 years
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men aged 19 to 80 years old at screening
  • Patients who maintained normal foot function before prostatectomy and are interested in restoring sexual function after surgery
  • PSA level <10 ng/mL before prostatectomy
  • Pathological Gleason sum ≤ 7(3+4 or 4+3) factor during prostatectomy
  • Local lesions that did not metastasize during prostatectomy (pT2, N0, M0 stage) factors
  • Patients more than 1 year after prostatectomy and PSA ≤ 0.04 ng/mL when screened without additional treatment other than surgery
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  • Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I(phos-phodiesterasetype-5 inhibitors) within last 8weeks.
  • Total score of 10 or more and 17 or less in the EF (Erectile function) field* of the International Erectile Function Questionnaire
  • 1, 2, 3, 4, 5, 15 questions for EF erectile function in the international erectile function questionnaire
  • Prevalence for erectile dysfunction at screening with more than 6 months
  • Who are willing to engage in sexual activity more than 4 times a month and have a constant partner for at least 3 months
  • Who do not have difficulty reading and understanding the contents of the questionnaire and who fill out a complete questionnaire
  • A person who voluntarily agrees to participate in this clinical trial and has signed the consent form by the subject and the subject partner

Who cannot join

  • Severe cardiovascular disease (angina pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit
  • Who cannot collect bone marrow due to bone marrow disease, etc.
  • Those with the following medical history/companion diseases A. Gentamicin hypersensitivity reaction B. Solid cancer or malignant blood disease within 5 years prior to screening C. Clinically significant cognitive impairment, dementia or psychiatric disorder D. Alcohol or substance abuse E. Priapism F. Severe respiratory diseases (COPD, asthma, pneumonia, pulmonary embolism, pneumothorax, etc.) G. Stroke H. Systemic autoimmune disease
  • Those with the following test results at the screening visit A. Liver disease or abnormal liver function (AST or ALT ≥ 3 times the normal upper limit of the organ) B. Severe renal impairment (serum creatinine≥ 2 mg/dL) C. Positive factors for pathogenic microbial tests (Hbs Ag, HCV Ab, HIV Ab, Syphilis) D. Uncontrolled high blood pressure (systolic blood pressure >170 mmHg or diastolic blood pressure >100 mmHg) or hypotension (systolic blood pressure <90 mmHg, diastolic blood pressure <50 mmHg) E. Who are outside the normal range of tumor marker tests (PSA, CEA, AFP) F. Hemorrhagic tendency (PT and aPTT> ULN x 1.5) G. Untreated hypogonadism or serum testosterone hormone less than 200 ng/dL
  • Those who possess the following therapeutic powers at screening A. Who are being treated for severe systemic or local infection B. Long-term use of anticoagulant (warfarin) (administered for more than 3 months as anticoagulant therapy) C. Vacuum compressor or intracavernous injection therapy within 7 days before screening (prostaglandin E1, papaverine, phentolamine, etc.) D. Immunosuppressants, alpha blockers or male hormones (androgens, anti-androgens) within 28 days prior to screening
  • Penile anatomical malformations (ex: Peyronie's disease) or penile implants or penile vascular procedures
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  • Who are receiving drugs* that are expected to affect the results of this clinical trial when judged by the investigator
  • If the partner is a woman of childbearing potential, those who are not willing to use an appropriate contraceptive method** during the clinical trial period
  • Contraceptive administration and implantation or intrauterine device, infertility procedures (vapectomy, tubal ligation, etc.), blocking method (condom, contraceptive diaphragm, vaginal sponge or cervical cap)
  • Who participated in other interventional clinical trials within 4 weeks prior to the screening visit and received clinical investigational drugs/investigational medical devices or received procedures
  • Who have or will be administered other cell therapy products
  • A person who is judged to be inappropriate to participate in this test when judged by the examiner
  • Random Inclusion Criteria:
  • Total score of 10 or more and 17 or less in the EF (Erectile function) field* of the International Erectile Function Questionnaire (IIEF)
  • 1, 2, 3, 4, 5, 15 questions for EF erectile function in the international erectile function questionnaire
  • Who attempts sexual activity more than 4 times during the run-in period and has a failure rate (Sexual Encounter Profile) of 50% or more

Trial locations and contacts

4 sites in 1 country.

South Korea4 sites

  • Asan medical center

    Seoul

  • Ewha womans university medical center

    Seoul

  • Samsung medical center

    Seoul

  • Seoul ST. Mary's hospital

    Seoul

Other trials in South Korea

About this study

Official title: An Single-blind, Multi-center, Randomization, Phase Ⅱ Study to Evaluate Efficacy and Safety of Cellgram-ED (Autologous Bone Marrow-derived Mesenchymal Stem Cells) in Erectile Dysfunction Patients With Following Radical Prostatectomy

This phase II clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.

Read the detailed description

To evaluate the efficacy and efficacy for 12 months after a single dose of Cellgram-ED in patients with erectile dysfunction after radical prostatectomy.

Being tested
Cellgram-ED
Medical subject headings
Erectile Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cellgram-EDBiological

    Also called Autologous bone marrow derived mesenchymal stem cell

    Patients will receive single injection of Cellgram-ED(mesenchymal stem cell) intracavernously.

Study groups in NCT04594850
Study groupRoleWhat they receive
Placebo-Control groupNo interventionSingle intracavernous injection of Placebo Oral PDE5-inhibitor can take daily and on demand.
Injection group: Cellgram-EDExperimentalSingle intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take daily and on demand.
Receives: Biological: Cellgram-ED

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value

    Descriptive statistics for the amount of change at administration of the investigational drug compared to the baseline value for each administration group are presented and analyzed by an analysis of covariance (ANCOVA)

    Erectile Function (Q1,2,3,4,5,15) : Min 6 ~ Max 30 Orgasmic Function (Q9,10) : Min 2 ~ Max 10 Sexual Desire (Q11,12) : : Min 2 ~ Max 10 Intercourse Satisfaction (Q6,7,8): : Min 3 ~ Max 15 Overall Satisfaction (Q13,14) : Min 2 ~ Max 10

    Measured: 6 month

Secondary outcomes (4)

  1. The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value

    Descriptive statistics for the amount of change at administration of the investigational drug compared to the baseline value for each administration group are presented and analyzed by an analysis of covariance (ANCOVA)

    Erectile Function (Q1,2,3,4,5,15) : Min 6 ~ Max 30

    Measured: month 1, 3, 6, 9 and 12

  2. Changes in SEP Q 2 and Q 3 evaluation after administration of investigational drug compared to baseline

    Descriptive statistics for the success rate change at each time point and baseline value for each administration group are presented and analyzed by covariance analysis (ANCOVA)

    SEP 2 Were you able to insert your penis into your partner's vagina? Yes or No SEP 3 Did your erection last long enough to have successful intercourse? Yes or No

    Measured: month 1, 3, 6, 9 and 12

  3. Global Assessment Question (GAQ) evaluation after administration of investigational drugs

    The frequency and percentage of each time point by administration group are presented and analyzed by Pearson's chi-square test or Fisher's exact test

    Did Cellgram-ED improve your Erectile Function? Yes or No If so, did Cellgram-ED improve the ability to have sex? Yes or No

    Measured: month 1, 3, 6, 9 and 12

  4. Changes in Penile Doppler Sonography(PDS) level after administration of clinical trial drug compared to baseline

    For the continuous variable, descriptive statistics for each time point in each administration group and the change at each time point compared to the baseline value are presented, and analyzed by covariance analysis (ANCOVA)

    PDS results are obtained 5 min, 10 min, 15 min, 20 min, 25 min and 30 min after intracavernosal injection.

    The peak systolic velocity (PSV) is assessed as follows: >25 cm/s is considered to be normal, 20-25 cm/s is considered to be mild ED, 12-20 cm/s is considered to be moderate ED, <12 cm/s is considered to be severe arteriogenic impotence.

    The end diastolic velocity (EDV) is assessed as follows: 5 cm/s is considered to be a normal value, >5 cm/s is considered to indicate a veno-occlusive disorder.

    Measured: month 6, 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Oct 2020
  2. Study start19 Oct 2020
  3. Primary completion7 Jan 2026
  4. Study completion7 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
54 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04594850
Sponsor's protocol ID
PMC-P-10
Acronym
Cellgram-ED
Status last verified
Feb 2026
First submitted
14 Oct 2020
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cellgram-ED in people with 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 13 inclusion and 16 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: finished, as of the sponsor's last update on 9 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The amount of change in EF score in the International Erectile Function Questionnaire (IIEF) at administration of the clinical trial drug compared to the baseline value (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04594850.

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 9 Feb 2026.

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