Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 入组人数
- 18
- 主要终点
- Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
研究概览
简要总结
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
详细描述
This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Standard risk GVHD patients with hematological malignancies older than 18 years;
- •High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
- •Well informed about this study and signed a consent form before the trial;
- •Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
- •No evidence of lung infection by X-rays examination;
- •Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
- •Normal liver and kidney function: Serum bilirubin≤35µmol/L, AST/ALT was less than 2 times the upper limit of normal value, and serum creatinine ≤130µmol/L
排除标准
- •Reduce pretreatment dose or secondary transplantation;
- •Participate other clinical trials within 2 months before this study;
- •Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
- •History of severe allergic disease or is allergic to one or more drugs;
- •Patients who are considered unsuitable for the study by the investigator.
研究组 & 干预措施
hAESCs
Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10^6 cell/kg.
干预措施: Human amniotic epithelial stem cells（hAESCs） (Biological)
placebo (cell preservation solution)
Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT.
干预措施: placebo (cell preservation solution) (Biological)
结局指标
主要结局
Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
时间窗: 1 year
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study. hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE.
次要结局
- Immune reconstitution 6 months before and after hematopoietic stem cell transplantation(6 months)
- Incidence of CMV and EBV infection(1 year)
- Rate of acute graft-versus-host disease in patients(1 year)
- Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured(1 month)