NCT04850469

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

Study of Exosomes Derived From Mesenchymal Stem Cells on the Therapy for Children With Severe Infection

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 29 Days – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multidirectional differentiation potential. studies revealed that local or systemic administration of mesenchymal stem cell-derivrd exosomes (MSC-Exo) efficiently suppressed detrimental immune response in inflamed tissues and promoted survival and regeneration of injured parenchymal cells. European Union countries have written MSCs into treatment guidelines for refractory graft-versus-host disease. In China, the technology for isolation, in vitro culture and expansion of MSCs is already mature. With further research on the therapeutic efficacy of MSC-Exo and the development of clinical trials, it is expected to become a treatment for severe illness. A predictable infection plan is going to be widely used in clinics to provide individualized treatment for patients, improve the prognosis of patients and improve the quality of life. The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded.

Conditions

• Sepsis
• Critical Illness

Timeline

• Start date: 2022-09-01
• Primary completion: 2023-12-31
• Completion: 2024-12-31
• First posted: 2021-04-20
• Last updated: 2022-06-15

Locations

1 site across 1 country: China