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

Not Applicable

• Conditions: Acute-graft-versus-host Disease
• Interventions: Biological: hAECs

• Registration Number: NCT03764228
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-03
• Study First Posted: 2018-12-05
• Study Start: 2020-07-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01
• Primary Completion: 2021-07-01
• Study Completion: 2022-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 27

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hAECs	hAECs	Infusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10\^6, 2×10\^6, 5×10\^6 cell/kg, successively.

Primary Outcome Measures

Name	Time	Method
Occurrence of adverse events	1 year	Safety of HSCT combined with hAECs infusion;

Secondary Outcome Measures

Name	Time	Method
GVHD	1 year	Occurrence of Graft-versus-host disease after hAECs infusion

Trial Locations

Locations (2)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China