NCT02933827已完成1 期
A Phase I/II Study to Evaluate the Safety and Efficacy of Allogeneic Infusion of Adipose-Derived Stem Cells in Moderate to Severe Chronic Kidney Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 3
- 主要终点
- Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)
研究概览
简要总结
- To assess the safety of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
- To assess the efficacy of allogeneic injection of expanded ADSCs to patients with Moderate to Severe Chronic Kidney Disease
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient is eligible for the study if all of the followings apply:
- •Aged 20-80 years (inclusive)
- •With chronic kidney disease (CKD)stage 3B to 4 (eGFR 15 to 44 mL/min/1.73m2 (inclusive)) Note : eGFR = estimated glomerular filtration rate
- •Having provided informed consent
排除标准
- •Any patient meeting any of the exclusion criteria will be excluded from study participation.
- •Ascertained hypersensitivity to any component used in the study Note: including gentamicin, DMSO, Agglutex (heperin)
- •With inadequate hematologic function with: absolute neutrophil count (ANC) <1,500/μL OR platelets < 100,000/μL OR Hemoglobin < 8 g/dL
- •With inadequate hepatic function with: serum bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT) or alkaline phosphatase (AKP) > 2.5 x the institutional upper limit of normal (ULN)
- •With hemoglobin A1c (HbA1c) > 8.0%
- •With serious prior or ongoing medical conditions (e.g. concomitant illness such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition, alcoholism, drug abuse), medical history, physical findings, ECG findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the patient
- •Pregnant or lactating women or premenopausal with childbearing potential but not taking reliable contraceptive method(s) during the study period
- •With body mass index (BMI) greater or equal to 36 kg/m2
- •With known history of human immunodeficiency virus (HIV) infection or any type of hepatitis
- •Judged to be not applicable to this study by investigator such as difficulty of follow-up observation
- •With any other serious diseases/medical history considered by the investigator not in the condition to enter the trial
- •Having participated other investigational study within 4 weeks of entering this study
- •Known or suspected abuse of alcohol or narcotics
- •With known history of cancer within past 5 years
- •With any autoimmune disease
- •With cystic kidney disease or requiring kidney dialysis
- •With precancerous condition or with cancer within past 5 years before Screening visit
研究组 & 干预措施
Low dose:
Experimental
ELIXCYTE 8 mL (ADSC 6.4*10^7 cells in total)
干预措施: ELIXCYTE (Drug)
Middle dose
Experimental
ELIXCYTE 24 mL (ADSC 19.2*10^7 cells in total)
干预措施: ELIXCYTE (Drug)
High dose
Experimental
ELIXCYTE 40 mL (ADSC 32.0*10^7 cells in total)
干预措施: ELIXCYTE (Drug)
结局指标
主要结局
Change from baseline to Week 24 visit in estimated glomerular filtration rate (eGFR)
时间窗: Week 0, 24
or Phase II
Incidence of adverse events (AEs) and serious adverse events (SAEs)
时间窗: Week 48
for Phase I
次要结局
- Change from baseline to all post-treatment visits in creatinine(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in blood urea nitrogen (BUN)(Weeks 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in blood cystatin C(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine total protein-creatinine ratio (UPCR)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in plasma neutrophil gelatinase-associated lipocalin (NGAL) by enzyme-linked immunosorbent assay (ELISA)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine kidney injury molecule-1(KIM-1)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine interleukin 18 (IL-18)(Weeks 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine liver-type fatty acid-binding protein (L-FABP)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine neutrophil gelatinase-associated lipocalin (NGAL)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine cystatin C(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in hemoglobin A1c(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in fasting plasma glucose(Weeks 0, 2, 4, 12, 24, 36, 48)
- Percentage of patients with hypoglycemia (defined as blood glucose < 55 mg/dL or 3.0 mmol/L) at all post-treatment visits(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in body weight(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in urine microalbumin-to-creatinine ratio (UMCR)(Weeks 0, 2, 4, 12, 24, 36, 48)
- Change from baseline to all post-treatment visits in eGFR(Weeks 0, 2, 4, 12, 24, 36, 48)
研究者
研究点 (3)
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