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

Acute-graft-versus-host Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03764228
• Other study ID #: 2018PHD006-01
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: July 1, 2022

Study information

• Verified date: September 2020
• Source: Peking University People's Hospital
• Contact: Xiangyu Zhao
• Phone: 010-88325949
• Email: 13520122292[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: July 1, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute-graft-versus-host Disease
• Graft vs Host Disease

Intervention

Biological:
• hAECs
Human amniotic epithelial cells(hAECs)

Locations

Country	Name	City	State
China	Peking University Institute of Hematology	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of adverse events	Safety of HSCT combined with hAECs infusion;	1 year
Secondary	GVHD	Occurrence of Graft-versus-host disease after hAECs infusion	1 year