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

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