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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT03764228

Collaborator

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China (Industry)

Enrollment

Locations

Arm

Anticipated Duration (Months)

13.5

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute-graft-versus-host Disease	Biological: hAECs	N/A

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、2×106、5×^6 cell/kg, successively.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

27 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 1, 2020

Anticipated Primary Completion Date :

Jul 1, 2021

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Biological: hAECs Human amniotic epithelial cells（hAECs）

Arm

Intervention/Treatment

Experimental: 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.

Biological: hAECs

Human amniotic epithelial cells（hAECs）

Outcome Measures

Primary Outcome Measures

Occurrence of adverse events [1 year]
Safety of HSCT combined with hAECs infusion;

Secondary Outcome Measures

GVHD [1 year]
Occurrence of Graft-versus-host disease after hAECs infusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Institute of Hematology	Beijing	Beijing	China	100044
2	Peking University People's Hospital	Beijing	Beijing	China	100044

Sponsors and Collaborators

Peking University People's Hospital
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Investigators

Principal Investigator: Xiaojun Huang, Peking University People's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiaojun Huang,MD, Director of the Hematology Department, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT03764228

Other Study ID Numbers:

2018PHD006-01

First Posted:

Dec 5, 2018

Last Update Posted:

Oct 1, 2020

Last Verified:

Sep 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Xiaojun Huang,MD, Director of the Hematology Department, Peking University People's Hospital

human amniotic epithelial cells(hAECs)

Acute-graft-versus-host disease（aGVHD）

Additional relevant MeSH terms:

Graft vs Host Disease

Study Results

No Results Posted as of Oct 1, 2020