NCT05131412

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 8, 2018

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 23, 2021

Completed
Last Updated

December 3, 2021

Status Verified

November 1, 2021

Enrollment Period

2.4 years

First QC Date

November 11, 2021

Last Update Submit

November 22, 2021

Conditions

PneumoniaHematopoietic Stem Cell Transplantation

Keywords

Mesenchymal Stromal CellPneumoniaHematopoietic Stem Cell Transplantation

Outcome Measures

Primary Outcomes (2)

  • overall cure rate

    the proportion of cured cases in all cases

    12 months

  • time to cure

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

    12 months

Study Arms (2)

mesenchymal stromal cell

Patients treated with mesenchymal stromal cell

non-mesenchymal stromal cell

Patients treated without mesenchymal stromal cell

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Patients who underwent hematopoietic stem cell transplantation (HSCT) in Guangzhou Women and Children's Medical Center and got pneumonia after HSCT.

You may qualify if:

  • patients with pneumonia after HSCT;
  • patients under the age of 18 years;
  • patients with normal pulmonary function before HSCT.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou Women and Children's Medical Center

Guangzhou, Guangdong, 510623, China

Location

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hua Jiang

    Guangzhou Women and Children's Medical Center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 11, 2021

First Posted

November 23, 2021

Study Start

August 8, 2018

Primary Completion

January 1, 2021

Study Completion

October 31, 2021

Last Updated

December 3, 2021

Record last verified: 2021-11

Locations

CN(1)