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

NCT03764228 | Unknown DMC

• 1 other identifier: 2018PHD006-01
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Acute-graft-versus-host Disease

Keywords

human amniotic epithelial cells(hAECs); Acute-graft-versus-host disease（aGVHD）

Outcome Measures

Primary Outcomes (1)

• Occurrence of adverse events

  Safety of HSCT combined with hAECs infusion;

  1 year

Secondary Outcomes (1)

• GVHD

  1 year

Study Arms (1)

hAECs

EXPERIMENTAL

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

Interventions

hAECs BIOLOGICAL

Human amniotic epithelial cells（hAECs）

hAECs

Eligibility Criteria

• Age: 8 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (2)

Peking University Institute of Hematology

Beijing, Beijing Municipality, 100044, China

RECRUITING

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 38802569 DERIVED

Study Officials

• Xiaojun Huang

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao

CONTACT

010-88325949; 13520122292@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Hematology Department

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 5, 2018
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: July 1, 2022
• Last Updated: October 1, 2020

Record last verified: 2020-09

Locations

CN (2)