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

Peking University

Status

Unknown

Conditions

Acute-graft-versus-host Disease

Treatments

Biological: hAECs

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03764228

2018PHD006-01

Details and patient eligibility

About

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

Full description

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.

Enrollment

27 estimated patients

Sex

All

Ages

8 to 70 years old

Volunteers

No Healthy Volunteers

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.