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

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

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

Study Overview

• Status: Unknown
• Conditions: Acute-graft-versus-host Disease
• Intervention / Treatment: Biological: hAECs

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 Type: Interventional
• Enrollment (Anticipated): 27
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiangyu Zhao; Phone Number: 010-88325949; Email: 13520122292@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Xiang-Yu Zhao, M.D., PhD; Phone Number: 8610-88325949; Email: zhao_xy@bjmu.edu.cn
    • Beijing, Beijing, China, 100044
      • Recruiting
      • Peking University Institute of Hematology
      • Contact: Zhao Xiangyu; Phone Number: +861088325949; Email: xyz80421@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 70 years (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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）

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2020
• Primary Completion (ANTICIPATED): July 1, 2021
• Study Completion (ANTICIPATED): July 1, 2022

Study Registration Dates

• First Submitted: November 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: human amniotic epithelial cells(hAECs); Acute-graft-versus-host disease（aGVHD）
• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease
• Other Study ID Numbers: 2018PHD006-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No