hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

September 30, 2020 updated by: Xiaojun Huang,MD, Peking University People's Hospital

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

hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100044
        • Recruiting
        • Peking University Institute of Hematology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

leukemia patients with allogeneic HSCT

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cell counts of T cells, NK cells, B cells and monocytes
Time Frame: Day 7
proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients
Day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University People's Hospital

Collaborators

Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2020

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2022

Study Registration Dates

First Submitted

November 19, 2018

First Submitted That Met QC Criteria

November 29, 2018

First Posted (Actual)

November 30, 2018

Study Record Updates

Last Update Posted (Actual)

October 1, 2020

Last Update Submitted That Met QC Criteria

September 30, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • 2018PHB007-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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