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

Last updated: September 30, 2020
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT03764228
2018PHD006-01
  • Ages 8-70
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Standard risk GVHD patients with hematological malignancies;

  • High risk GVHD patients with hematological malignancies: haplotype hematopoietic stemcell 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, Hematopoieticcell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;

  • Normal liver and kidney function;

Exclusion

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 studyperiod, 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 Design

Total Participants: 27
Study Start date:
July 01, 2020
Estimated Completion Date:
July 01, 2022

Study 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.

Connect with a study center

  • Peking University Institute of Hematology

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Active - Recruiting

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