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

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

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

Official Title
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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

Conditions
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Erectile Dysfunction

Intervention / Treatment
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* Biological: Cellgram-ED


Participation Criteria
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Eligibility Criteria
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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 * 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 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 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Placebo-Control group<br>Single intracavernous injection of Placebo Oral PDE5-inhibitor can take daily and on demand. | |
| Experimental: Injection group: Cellgram-ED<br>Single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take daily and on demand. | Biological: Cellgram-ED<br>* Patients will receive single injection of Cellgram-ED(mesenchymal stem cell) intracavernously.<br>* Other names: Autologous bone marrow derived mesenchymal stem cell;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | month 1, 3, 6, 9 and 12 | 
| 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 | month 1, 3, 6, 9 and 12 | 
| 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 | month 1, 3, 6, 9 and 12 | 
| 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. | month 6, 12 |