NCT03764228Unknown不适用
Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Occurrence of adverse events
研究概览
简要总结
This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
详细描述
A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 8 Years 至 70 Years（Child, 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;
- •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;
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.
结局指标
主要结局
Occurrence of adverse events
时间窗: 1 year
Safety of HSCT combined with hAECs infusion;
次要结局
- GVHD(1 year)
研究者
Xiaojun Huang,MD
Director of the Hematology Department
Peking University People's Hospital
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Human Amniotic Membrane Grafting and Standard of Care Versus Standard of Care Alone in the Treatment of Venous Leg UlcersVenous Leg UlcerNCT01552447MiMedx Group, Inc.98
招募中
2 期
Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML PatientsIntermediate Risk Acute Myeloid LeukemiaHigh Risk Acute Myeloid LeukemiaNCT06394011The First Affiliated Hospital of Soochow University60
撤回
1 期
hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell TransplantationAcute Graft Versus Host DiseaseNCT06444022Nanfang Hospital, Southern Medical University18
招募中
不适用
Dehydrated Human Amnion Membrane and Standard of Care Versus Standard of Care Alone in Nonhealing Diabetic Foot UlcersUlcer FootFoot UlcerDiabetic FootDiabetic Foot UlcerNCT06550596Axolotl Biologix100
Unknown
2 期
An Amniotic Membrane Injection Comparing Two Doses (1 mL and 2 mL Injection) and a Placebo (Sterile Saline) in the Treatment of Osteoarthritis of the KneeOsteoarthritis, KneeNCT04612023Illinois Center for Orthopaedic Research and Education90