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

NCT ID: NCT03764228

Last Updated: 2020-10-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-07-01

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.

Conditions

Acute-graft-versus-host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

hAECs

Intervention Type: BIOLOGICAL

Human amniotic epithelial cells（hAECs）

Interventions

hAECs

Human amniotic epithelial cells（hAECs）

Intervention Type: BIOLOGICAL

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.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Xiaojun Huang,MD

Director of the Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaojun Huang

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital

Locations

Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiangyu Zhao

Role: CONTACT

13520122292@126.com

010-88325949

Facility Contacts

Zhao Xiangyu

Role: primary

xyz80421@126.com

+861088325949

Xiang-Yu Zhao, M.D., PhD

Role: primary

zhao_xy@bjmu.edu.cn

8610-88325949

References

Yang PJ, Zhao XY, Kou YH, Liu J, Ren XY, Zhang YY, Wang ZD, Ge Z, Yuan WX, Qiu C, Tan B, Liu Q, Shi YN, Jiang YQ, Qiu C, Guo LH, Li JY, Huang XJ, Yu LY. Human amniotic epithelial stem cell is a cell therapy candidate for preventing acute graft-versus-host disease. Acta Pharmacol Sin. 2024 Nov;45(11):2339-2353. doi: 10.1038/s41401-024-01283-y. Epub 2024 May 27.

Reference Type: DERIVED

PMID: 38802569 (View on PubMed)

Other Identifiers

2018PHD006-01

Identifier Type: -

Identifier Source: org_study_id