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

Pharmicell Co., Ltd.4 个研究点分布在 1 个国家目标入组 54 人2020年10月19日

适应症Erectile Dysfunction

干预措施Cellgram-ED

概览

阶段: 2 期
干预措施: Placebo-Control group
疾病 / 适应症: Erectile Dysfunction
发起方: Pharmicell Co., Ltd.
入组人数: 54
试验地点: 4
主要终点: 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
状态: 已完成
最后更新: 2个月前

概览研究者入排标准研究组 & 干预措施结局指标研究点相似试验

概览

简要总结

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

详细描述

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

注册库

clinicaltrials.gov

开始日期

2020年10月19日

结束日期

2026年1月7日

最后更新

2个月前

研究类型

Interventional

研究设计

Parallel

性别

Male

研究者

发起方

Pharmicell Co., Ltd.

责任方

Sponsor

入排标准

入选标准

•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

排除标准

•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

研究组 & 干预措施

Placebo-Control group

Single intracavernous injection of Placebo Oral PDE5-inhibitor can take daily and on demand.

Injection group: Cellgram-ED

Single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take daily and on demand.

干预措施: Cellgram-ED

结局指标

主要结局

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

时间窗: 6 month

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

次要结局

Global Assessment Question (GAQ) evaluation after administration of investigational drugs(month 1, 3, 6, 9 and 12)
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(month 1, 3, 6, 9 and 12)
Changes in SEP Q 2 and Q 3 evaluation after administration of investigational drug compared to baseline(month 1, 3, 6, 9 and 12)
Changes in Penile Doppler Sonography(PDS) level after administration of clinical trial drug compared to baseline(month 6, 12)