An Open, Single-center, Phase 1 Study to Evaluate Safety of Autologous Bone Marrow Derived Mesenchymal Stem Cell in Erectile Dysfunction.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Number and severity of adverse events
研究概览
简要总结
This phase I clinical trial is designed to evaluate the safety of autologous Mesenchymal Stem Cells (MSC) injected intracavernously.
详细描述
Cellgram-ED is autologous bone marrow-derived mesenchymal stem cells ex vivo expanded for approximately 30 days. Ten patients (Diabetes -associated ED; 5 patients, Postprostatectomy; 5patients) will be injected Cellgram-ED directly into the intracavernous. Patient will be evaluated the safety and potential efficacy of MSC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Postprostatectomy Erectile Dysfunction
- •A man aged 20 or older
- •Who is willing to consent to participate in the study concerned with improving sexual activity after prostatectomy, the man has maintained normal sexual activity prior to prostatectomy
- •Prior to prostatectomy PSA (prostate specific antigen) level<10 ng/mL
- •At the time of Prostatectomy, Pathological Gleason sum ≤7
- •At the time of Prostatectomy, Pathological stage ≤ T2c
- •2 years or more postprostatectomy patients with PSA level ≤ 0.04 ng/mL without additional therapy after prostatectomy
- •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.
- •IIEF, EF(erectile function) domain score is under 17
- •Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
- •Diabetes-associated Erectile Dysfunction
- •HbA1c is between 6.5% and 10% of man over 20 years of age with diabetes
- •Who cannot satisfy sexual activity(more than 4 times) with proper sexual stimulation in spite of taking maximum dose of oral PDE5I within last 8weeks.
- •IIEF, EF domain score is under 17
- •Who is willing to consent to participate in the study concerned with improving sexual activity
- •Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
排除标准
- •History of bone marrow disorders
- •Serum AST/ALT > 3 X upper limit of normal or Creatinine > 1.5 X upper limit of normal
- •History of hypersensitivity against a gentamycin
- •Severe cardiovascular disease(angina, arrhythmia, cardiac failure, stroke), kidney failure, respiratory failure
- •Positive for human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and syphilis test
- •Positive for PSA or CEA or AFP (Carcinoembryonic antigen), history of cancer in the last five years (except Prostatic cancer) Uncontrolled hypertension or hypotension (systolic blood pressure > 170 or < 90 mm Hg, diastolic pressure > 100 or < 50 mm Hg)
- •HbA1c exhibit greater than 10%
- •Men on anticoagulant treatment
- •Have a severe infectious disease
- •Testosterone level is less than 200ng/dl
- •Have a penile implant or willing to it
- •Patients with morphological changes of the penis
- •Patient's partner is trying to conceive during the trial period
- •Unwilling to participate in the study
- •Participating in other clinical trials in the past 30 days
- •Unable to compliance with protocol
- •Inappropriate patients to participate in the study according to the investigator
研究组 & 干预措施
Mesenchymal stem cell
Patients will receive single intracavernous injection of Mesenchymal stem cell. Oral PDE5-inhibitor can take on demand.
干预措施: mesenchymal stem cell (Drug)
结局指标
主要结局
Number and severity of adverse events
时间窗: 12month
Analyze the laboratory, vital sign, physical exam results from baseline to end of the study for investigate adverse reactions and view safety. An SAE suggests a significant hazard, contraindication, side-effect, or precaution. With respect to human clinical experience, this includes any event that: Results in death. Is life-threatening.\* Requires in-patient hospitalization or prolongation of existing hospitalization. Results in persistent or significant disability/incapacity. Is a congenital anomaly/birth defect. Other medically important condition Life-threatening in the definition of a SAE or adverse reaction refers to an event in which the patient was at risk of death at the time of event; it does not refer to an event, which hypothetically might have caused death if it were more severe.
次要结局
- Penile Doppler Sonography, PDS(month 6, 12)
- Change From Baseline in the International Index of Erectile Function(IIEF)(month 1, 3, 6, 9 and 12)
- Change From Baseline in Sexual Encounter Profile (SEP) Question 2(month 1, 3, 6, 9 and 12)
- Global Assessment Question (GAQ)(month 1, 3, 6, 9 and 12)