Stem cells aim to restore sexual function after prostate cancer surgery
NCT ID NCT04594850
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This phase 2 trial tested a single injection of stem cells (from the patient's own bone marrow) into the penis to treat erectile dysfunction in men who had their prostate removed due to cancer. Fifty-four men participated. The study measured changes in erectile function scores using a standard questionnaire.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- autologous bone marrow-derived mesenchymal stem cells
- What this could lead to
- If successful, this could offer a new treatment option for men with erectile dysfunction after prostate cancer surgery.
- What could go wrong
- This is an early-phase trial with only 54 participants. The treatment may not improve erectile function significantly, and long-term safety is not yet known.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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54 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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19 to 79 years
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men aged 19 to 80 years old at screening 2. Patients who maintained normal foot function before prostatectomy and are interested in restoring sexual function after surgery 3. PSA level \<10 ng/mL before prostatectomy 4. Pathological Gleason sum ≤ 7(3+4 or 4+3) factor during prostatectomy 5. Local lesions that did not metastasize during prostatectomy (pT2, N0, M0 stage) factors 6. Patients more than 1 year after prostatectomy and PSA ≤ 0.04 ng/mL when screened without additional treatment other than surgery 7. 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. 8. 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 9. Prevalence for erectile dysfunction at screening with more than 6 months 10. Who are willing to engage in sexual activity more than 4 times a month and have a constant partner for at least 3 months 11. Who do not have difficulty reading and understanding the contents of the questionnaire and who fill out a complete questionnaire 12. A person who voluntarily agrees to participate in this clinical trial and has signed the consent form by the subject and the subject partner Exclusion Criteria: 1. Severe cardiovascular disease (angina pectoris, myocardial infarction, unstable arrhythmia, heart failure, etc.) at the screening visit 2. Who cannot collect bone marrow due to bone marrow disease, etc. 3. 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 4. 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 5. 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 6. Penile anatomical malformations (ex: Peyronie's disease) or penile implants or penile vascular procedures 7. Who are receiving drugs\* that are expected to affect the results of this clinical trial when judged by the investigator 8. 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) 9. 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 10. Who have or will be administered other cell therapy products 11. A person who is judged to be inappropriate to participate in this test when judged by the examiner Random Inclusion Criteria: 1. 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 2. 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Asan medical center
Seoul, South Korea
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Ewha womans university medical center
Seoul, South Korea
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Samsung medical center
Seoul, South Korea
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Seoul ST. Mary's hospital
Seoul, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Shockwaves to the penis tested against erectile dysfunction
- Does having multiple wives affect Men's sexual health? a new survey asks
- Can adding shockwaves to platelet therapy boost erectile function?
- Shockwaves may speed up erectile recovery after prostate cancer surgery
- Can a Feather-Light penile monitor replace the uncomfortable gold standard?
- Can a Patient's own blood components outperform daily ED pills?