NCT04544215

A Clinical Study of Mesenchymal Progenitor Cell Exosomes Nebulizer for the Treatment of Pulmonary Infection

A Clinical Study of Allogeneic Human Adipose-derived Mesenchymal Progenitor Cell Exosomes (haMPC-Exos) Nebulizer for the Treatment of Carbapenem-resistant Gram-negative Bacilli-induced Pulmonary Infection

• Status: Suspended
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of haMPC-Exos treatment with pulmonary infection caused by gram-negative bacilli resistant to carbapenems.

Detailed description

Pulmonary infection is a critical disease threatening human health. With the extensive use of antibiotics, the incidence of clinical drug resistance has been on the rise significantly in recent years. Once drug resistance occurs, we will see a high mortality rate due to scarce therapies and a poor prognosis. It is almost impossible to surmount the severe pulmonary infection caused by drug-resistant bacteria only by upgrading antibiotics. The commonly used supportive therapies clinically, such as glucocorticoids and immunomodulators, also lack forceful medical evidence. Therefore, it is urgent to explore new treatments. Mesenchymal stem/progenitor cell exosomes are nano-sized vesicles secreted by mesenchymal stem/progenitor cells under certain conditions, which contain a lot of proteins, lipids and nucleic acids with tissue repair and immunomodulatory functions. Mesenchymal stem/progenitor cell exosomes are nano-sized vesicles secreted by mesenchymal stem/progenitor cells under certain conditions, which contain a lot of proteins, lipids and nucleic acids with tissue repair and immunomodulatory functions. Currently, it has been confirmed that stem cells can visibly improve the pathological changes of lungs caused by infection, lighten pulmonary edema, reduce protein exudation, mitigate alveolar inflammation, and remove bacteria. Thus, it brings new hope for the treatment of pulmonary infection caused by extensively drug-resistant bacteria. Patients were treated, in the research project, with well-suited noninvasive haMPC-Exos aerosol inhalation, in an attempt to verify the efficacy and safety of haMPC-Exos treatment with pulmonary infection caused by gram-negative bacilli resistant to carbapenems.

Conditions

• Drug-resistant

Interventions

Type	Name	Description
BIOLOGICAL	Dosage 1 of MPCs-derived exosomes	7 times aerosol inhalation of MPCs-derived exosomes (8.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).
BIOLOGICAL	Dosage 2 of MPCs-derived exosomes	7 times aerosol inhalation of MPCs-derived exosomes (16.0\*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).
BIOLOGICAL	No MPCs-derived exosomes	No aerosol inhalation of MPCs-derived exosomes

Timeline

• Start date: 2020-07-01
• Primary completion: 2024-12-01
• Completion: 2025-03-01
• First posted: 2020-09-10
• Last updated: 2024-07-22

Locations

1 site across 1 country: China