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

Primary Purpose

Acute-graft-versus-host Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hAECs
Sponsored by
Peking University People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute-graft-versus-host Disease focused on measuring human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）

Eligibility Criteria

8 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Peking University Institute of HematologyRecruiting
  • Peking University People's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

hAECs

Arm Description

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.

Outcomes

Primary Outcome Measures

Occurrence of adverse events
Safety of HSCT combined with hAECs infusion;

Secondary Outcome Measures

GVHD
Occurrence of Graft-versus-host disease after hAECs infusion

Full Information

First Posted
November 29, 2018
Last Updated
September 30, 2020
Sponsor
Peking University People's Hospital
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
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1. Study Identification

Unique Protocol Identification Number
NCT03764228
Brief Title
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Acronym
hAECs-GVHD
Official Title
Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
July 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
Collaborators
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute-graft-versus-host Disease
Keywords
human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hAECs
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
hAECs
Intervention Description
Human amniotic epithelial cells（hAECs）
Primary Outcome Measure Information:
Title
Occurrence of adverse events
Description
Safety of HSCT combined with hAECs infusion;
Time Frame
1 year
Secondary Outcome Measure Information:
Title
GVHD
Description
Occurrence of Graft-versus-host disease after hAECs infusion
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiangyu Zhao
Phone
010-88325949
Email
13520122292@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaojun Huang
Organizational Affiliation
Peking University People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Institute of Hematology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhao Xiangyu
Phone
+861088325949
Email
xyz80421@126.com
Facility Name
Peking University People's Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100044
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiang-Yu Zhao, M.D., PhD
Phone
8610-88325949
Email
zhao_xy@bjmu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

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

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