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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05131412
Other study ID # GWCMC_HJ_XY_001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 8, 2018
Est. completion date October 31, 2021

Study information

Verified date November 2021
Source Guangzhou Women and Children's Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date October 31, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender All
Age group 1 Year to 17 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Hematopoietic Stem Cell Transplantation
  • Pneumonia

Locations

Country Name City State
China Guangzhou Women and Children's Medical Center Guangzhou Guangdong

Sponsors (1)

Lead Sponsor Collaborator
Guangzhou Women and Children's Medical Center

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary overall cure rate the proportion of cured cases in all cases 12 months
Primary time to cure the time from the first diagnosis of pneumonia to a cure was achieved 12 months
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