To evaluate allogeneic human mesenchymal stem cell exosomes (hMSC-Exos) in the treatment of acute respiratory distress syndrome (ARDS)
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)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
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)
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)
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)
Ruijin Hospital, Medical School of Shanghai Jiaotong University
Shanghai, Shanghai Municipality, China
Incidence of adverse reaction
Incidence of adverse reaction
Time frame: up to 14 days
TTCI
Time to Clinical improvement
Time frame: up to 28 days
28-day mortality
28-day mortality
Time frame: up to 28 days
Murray lung injury score
The minimum value is 0 and the maximum are 16. Higher scores mean a worse outcome.
Time frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
PaO2/FiO2
oxygen index: the ratio of alveolar oxygen partial pressure to fraction of inspired oxygen
Time frame: baseline and Day 3, Day7, Day14, Day28, Day60
SOFA score
The minimum value is 0 and the maximum are 48. Higher scores mean a worse outcome.
Time frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
ApachⅡ score
The minimum value is 0 and the maximum are 24. Higher scores mean a worse outcome.
Time frame: baseline and Day 1, Day 2, Day 3, Day 4, Day 5, Day6, Day7, Day14, Day28, Day60
The number of days the survivor was in ICU
The number of days the survivor was in ICU
Time frame: up to 60 days
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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)
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)
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)