NCT04602104

A Clinical Study of Mesenchymal Stem Cell Exosomes Nebulizer for the Treatment of ARDS

A Multiple, Randomized, Double-blinded, Controlled Clinical Study of Allogeneic Human Mesenchymal Stem Cell Exosomes (hMSC-Exos) Nebulized Inhalation in the Treatment of Acute Respiratory Distress Syndrome

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

Detailed description

According to the 2012 Berlin diagnostic criteria, there are currently more than 3 million ARDS patients worldwide, accounting for about 10% of patients in the intensive care unit (ICU). In recent years, the incidence of ARDS has increased significantly, which has significantly increased the social and economic burden. The impact of ARDS can even be compared with tumors, AIDS or myocardial infarction. There are the basic clinical treatments, such as using various ventilation methods to improve hypoxia and choosing alternative therapies to improve renal insufficiency. Therefore, there is still a lack of specific treatment measures. Exosomes are naturally occurring nanosized vesicles and comprised of natural lipid bilayers with the abundance of adhesive proteins that readily interact with cellular membranes. Studies have confirmed that MSC-Exos can improve most of the pathological changes caused by lung infection, reduce pulmonary edema, reduce protein exudation, reduce alveolar inflammation, and clear bacterial infections. Thus, it brings new hope for the treatment of ARDS. The purpose of this study is to evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)

Conditions

• Acute Respiratory Distress Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	low dose hMSC-Exos	basic treatment and 7 times aerosol inhalation of hMSC-Exos (2.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
BIOLOGICAL	medium dose hMSC-Exos	basic treatment and 7 times aerosol inhalation of hMSC-Exos (8.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
BIOLOGICAL	high dose hMSC-Exos	basic treatment and 7 times aerosol inhalation of hMSC-Exos (16.0\*10\^8 particles at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
BIOLOGICAL	Dosage 1of hMSC-Exos	basic treatment and 7 times aerosol inhalation of hMSC-Exos (a quarter of MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
BIOLOGICAL	Dosage 2 of hMSC-Exos	basic treatment and 7 times aerosol inhalation of hMSC-Exos (MTD/day at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)
BIOLOGICAL	No hMSC-derived exosomes	basic treatment and 7 times aerosol inhalation of normal saline (at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7)

Timeline

• Start date: 2020-11-30
• Primary completion: 2022-11-10
• Completion: 2023-01-11
• First posted: 2020-10-26
• Last updated: 2024-07-22

Locations

1 site across 1 country: China