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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03764228

Acronym

hAECs-GVHD

Enrollment

Registered

2018-12-05

Start date

2020-07-01

Completion date

2022-07-01

Last updated

2020-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute-graft-versus-host Disease

Keywords

human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）

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.

Interventions

BIOLOGICALhAECs

Human amniotic epithelial cells（hAECs）

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 70 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Occurrence of adverse events	1 year	Safety of HSCT combined with hAECs infusion;

Secondary

Measure	Time frame	Description
GVHD	1 year	Occurrence of Graft-versus-host disease after hAECs infusion

Countries

China

Contacts

Primary ContactXiangyu Zhao

13520122292@126.com010-88325949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026