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NCT03759899 Clinical Trial

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Leukemia Clinical Trial

Official title:
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03759899
Other study ID # 2018PHB007-01
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2020
Est. completion date July 2022

Study information
Verified date September 2020
Source Peking University People's Hospital
Contact xiangyu Zhao
Phone 010-88325949
Email zhao_xy@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Description:

Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date July 2022
Est. primary completion date July 2021
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- leukemia patients with allogeneic HSCT

- KFS score >90

- after transplantation, the patient was implanted (peripheral blood neutrophil absolute value >500/ul for 3 consecutive days)

- no uncontrolled infection after transplantation

- activity II above aGVHD

- patients agreed to participate in the study

Exclusion Criteria:

- patients refused to participate in the study

- patients have poor compliance

- has received hormone therapy

- patients had serious heart, lung, liver, kidney and other vital organs damage

- researchers believe that patients who are not suitable for observation study

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
China Peking University Institute of Hematology 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 Cell counts of T cells, NK cells, B cells and monocytes proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients Day 7
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