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MSCTPHSCT: Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation

Sponsor
Guangzhou Women and Children's Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT05131412
Collaborator
(none)
107
Enrollment
1
Location
38.8
Actual Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians.

    Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated.

    By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    107 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation: a a Retrospective Cohort Study
    Actual Study Start Date :
    Aug 8, 2018
    Actual Primary Completion Date :
    Jan 1, 2021
    Actual Study Completion Date :
    Oct 31, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    mesenchymal stromal cell

    Patients treated with mesenchymal stromal cell
    non-mesenchymal stromal cell

    Patients treated without mesenchymal stromal cell

    Outcome Measures

    Primary Outcome Measures

    1. overall cure rate [12 months]

      the proportion of cured cases in all cases

    2. time to cure [12 months]

      the time from the first diagnosis of pneumonia to a cure was achieved

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patients with pneumonia after HSCT;

    • patients under the age of 18 years;

    • patients with normal pulmonary function before HSCT.

    Exclusion Criteria:
    • patients with other severe complications in progress when pneumonia occurred.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Guangzhou Women and Children's Medical Center Guangzhou Guangdong China 510623

    Sponsors and Collaborators

    • Guangzhou Women and Children's Medical Center

    Investigators

    • Study Director: Hua Jiang, Guangzhou Women and Children's Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Xu Yang, Principal Investigator, Guangzhou Women and Children's Medical Center
    ClinicalTrials.gov Identifier:
    NCT05131412
    Other Study ID Numbers:
    • GWCMC_HJ_XY_001
    First Posted:
    Nov 23, 2021
    Last Update Posted:
    Dec 3, 2021
    Last Verified:
    Nov 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Xu Yang, Principal Investigator, Guangzhou Women and Children's Medical Center
    Mesenchymal Stromal Cell
    Pneumonia
    Hematopoietic Stem Cell Transplantation
    Additional relevant MeSH terms:
    Pneumonia

    Study Results

    No Results Posted as of Dec 3, 2021