Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation

This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.

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.

Inclusion Criteria:

• 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;

Exclusion Criteria:

• 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.