Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Inje… (NCT04594850) | Clinical Trial Compass
CompletedPhase 2
Clinical Trial to Evaluate Efficacy and Safety of of Autologous Mesenchymal Stem Cells (MSC) Injected Intracavernously
South Korea54 participantsStarted 2020-10-19
Plain-language summary
This phase II clinical trial is designed to evaluate the efficacy and safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
Who can participate
Age range19 Years – 79 Years
SexMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
Exclusion criteria
✕. 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
✕. Who are receiving drugs\* that are expected to affect the results of this clinical trial when judged by the investigator
What they're measuring
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
✕. 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