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

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

Detailed Description
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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.

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

Conditions
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Acute-graft-versus-host Disease

Intervention / Treatment
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* Biological: hAECs


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hAECs<br>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. | Biological: hAECs<br>* Human amniotic epithelial cells（hAECs）<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of adverse events | Safety of HSCT combined with hAECs infusion; | 1 year | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）