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hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Sponsor
Peking University People's Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT03759899
Collaborator
Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China (Industry)
30
Enrollment
1
Location
24
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
    Actual Study Start Date :
    Jul 1, 2020
    Anticipated Primary Completion Date :
    Jul 1, 2021
    Anticipated Study Completion Date :
    Jul 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Cell counts of T cells, NK cells, B cells and monocytes [Day 7]

      proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Peking University Institute of Hematology Beijing Beijing China 100044

    Sponsors and Collaborators

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

    Investigators

    • Principal Investigator: Xiaojun Huang, Peking University People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xiaojun Huang,MD, Director of the Hematology Department, Peking University People's Hospital
    ClinicalTrials.gov Identifier:
    NCT03759899
    Other Study ID Numbers:
    • 2018PHB007-01
    First Posted:
    Nov 30, 2018
    Last Update Posted:
    Oct 1, 2020
    Last Verified:
    Sep 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Oct 1, 2020