Status:
UNKNOWN
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
Lead Sponsor:
Peking University People's Hospital
Collaborating Sponsors:
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
Conditions:
Acute-graft-versus-host Disease
Eligibility:
All Genders
8-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT03764228
Start Date
July 1 2020
End Date
July 1 2022
Last Update
October 1 2020
Active Locations (2)
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1
Peking University Institute of Hematology
Beijing, Beijing Municipality, China, 100044
2
Peking University People's Hospital
Beijing, Beijing Municipality, China, 100044