Study of MSC-Exo on the Therapy for Intensively Ill Children

NCT04850469 | Withdrawn

• 1 other identifier: fdpicu-13
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

At present, a number of projects related to MSCs have been approved for graft-versus-host disease, myocardial infarction, Crohn's disease and other diseases, indicating a strong therapeutic potential of MSCs. However, the efficacy of MSC-Exo for severely infected children is not fully evaluated. In our study, patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. This study will evaluate the application and therapeutic effect of MSC-Exo in severely infected children, and determine the Optimal dosage and infusion.

Conditions

Sepsis; Critical Illness

Keywords

Sepsis; Critical Illness; Mesenchymal Stem Cell Derived Exosomes

Outcome Measures

Primary Outcomes (3)

• The death rate of children

  The death rate of children in 28 days after their discharged from PICU

  within 28 days after they discharged from PICU

• Marshall Multiple Organ Dysfunction Score

  The Marshall Multiple Organ Dysfunction Score (MODS) assesses the same six organ systems using slightly different values for four grades of organ dysfunction. The total score, ranging from 0 to 24, arises from the sum of all single organ scores using the first measured value of the day. Intervals for the most abnormal value of each variable were constructed on a scale from 0 to 4 so that a value of 0 represented essentially normal function and was associated with an ICU mortality rate of \< 5%, whereas a value of 4 represented marked functional derangement and an ICU mortality rate of \> or = 50%.

  Within 3 to 15 days after the start of treatment

• the APPS score

  The APPS is a 9-point score that is calculated by measuring the age, PaO2/FIO2 ratio, and plateau pressure at 24 h after the patient is diagnosed with moderate to severe ARDS and counting each one to 1-3. Since many variables are not needed for calculations, clinicians can easily predict the in-hospital mortality of mechanically ventilated patients with moderate to severe ARDS patients at bedside.

  Within 3 to 15 days after the start of treatment

Secondary Outcomes (1)

• length of stay in PICU

  up to 28 days

Study Arms (2)

trial group

Mesenchymal Stem Cell-Derived Exosomes

control group

conventional treatment

Eligibility Criteria

• Age: 29 Days - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023

You may qualify if:

• children hospitalized in PICU of Children's Hospital of Fudan University

You may not qualify if:

• discharge within 48 hours
• patients without informed consent
• incomplete clinical and demographic data

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Sepsis; Critical Illness

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Guoping Lu, Doctor

  Children's Hospital of Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2021
• First Posted: April 20, 2021
• Study Start: September 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: June 15, 2022

Record last verified: 2022-06

Locations

CN (1)