Effect of Mesenchymal Stem Cell-derived Exosomes on Lung Diseases of Children
Study Details
Study Description
Brief Summary
Lung disease is the primary cause of hospitalization for children. For example, ARDS caused by severe lung infection is a serious clinical problem. The affected patients have serious clinical symptoms, and may have pulmonary complications such as lung consolidation and fibrosis, which will worsen the quality of life. Therefore, effective treatment is urgently needed. The exosomes derived from mesenchymal stem cells (MSC-Exo) has become a candidate treatment strategy for pulmonary inflammatory diseases through its immunomodulatory effect. In this study, we explored the role of MSC-Exo in children's lung diseases and determined the therapeutic mechanism of MSC-Exo. According to the inclusion and exclusion criteria, recruit subjects who meet the study, and then analyze their clinical data and blood, sputum or alveolar lavage fluid samples.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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Inclusion criteria of the test group: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were infection and sepsis;
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Inclusion criteria of the control group: control 1: (1) Meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were non-infectious factors.
Control 2: Healthy children
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Exclusion criteria of the test group: (1) Patients with hemodynamic instability Patients with pulmonary hypertension;(2) Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, et al.
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The collection of clinical data includes: name, sex, age, hospitalization number, date of hospitalization, main diagnosis, course of disease, main examination and test results, medication, respiratory support, prognosis, etc.
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Collect peripheral blood serum, sputum or alveolar lavage fluid samples for target sequencing.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| experimental group (1) meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were infection and sepsis. |
Other: exosomes
In the experimental group and the control group1, the clinical efficacy and prognosis were observed after received exosomes, and the hematological indexes were measured.
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| control group1 (1) meeting the specific diagnostic criteria for related lung diseases; (2) The factors of lung diseases were non-infectious factors. |
Other: exosomes
In the experimental group and the control group1, the clinical efficacy and prognosis were observed after received exosomes, and the hematological indexes were measured.
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| control group2 Healthy children |
Outcome Measures
Primary Outcome Measures
- Oxygen consumption [an average of 1week]
The proportion of deoxygenation in subjects and the oxygen consumption of patients after exosomes infusion. Physiological parameter would be used to assess this outcome measure.
Secondary Outcome Measures
- Incidence rate of adverse events [up to 1 year]
Incidence of adverse events related to infusion of exosomes to evaluate the safety of exosomes in the treatment of lung diseases. Questionnaires would be used to assess this outcome measure.
Other Outcome Measures
- Pulmonary function [up to 2 weeks]
Pulmonary function tests were performed before and after infusion to evaluate the pulmonary function changes of subjects in the test group after infusion of exosomes to evaluate the long-term efficacy of exosomes in the treatment of lung diseases. Physiological parameter would be used to assess this outcome measure.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Clinical diagnosis of specific lung diseases, such as ALI/ARDS, asthma, et al.
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Voluntary inclusion of researchers.
Exclusion Criteria:
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Patients with hemodynamic instability
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Patients with pulmonary hypertension
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Patients with congenital heart disease, congenital genetic metabolic disease, epilepsy, acute and chronic renal insufficiency, nephrotic syndrome, diabetes, etc.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Children's Hospital of Chongqing Medical University
Investigators
- Principal Investigator: Zhou Mi, Master, Chongqing Medical University
- Principal Investigator: Ding Fengxia, Doctor, Chongqing Medical University
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- ChongqingMU