Acute Lung Injury
Conditions
Brief summary
The patients suffered from acute lung ininjury (200\<PaO2/FiO2 ≤ 300) will be divided into two groups: MSCs-treated group: patients are treated by intravenous injection of hUC-MSCs suspention ; control group: patients were treated with vehicle(Albumin) . The standard Therapies of acute lung injury were the same in both groups. In the following-up days, all the patients were monitored by the same items to evaluate the therapeutic effects.
Interventions
BIOLOGICALhuman derived umbilical cord derived mesenchymal stem cells
intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 1.≤ 3 days (72h) * 2.Age ≥18 years, ≤65 years * 3.200\<PaO2/FiO2 ≤ 300 * 4.Chest X-ray/chest CT : infiltrates of both lungs * 5.Need assisted ventilation (ventilation or high flow oxygen therapy) * 6.No left heart failure, pulmonary edema * 7.Agree to participate and signe an informed consent
Exclusion criteria
* 1.Life expectancy \<3 months due to non-respiratory failure * 2.Patients receiving extracorporeal membrane oxygenation support therapy(ECMO),high frequency oscillatory ventilation * 3.History of HIV, malignant tumors, or impaired immune function * 4.Patients accepted major surgery in the past 14 days (such as tumor removal, thoracotomy, heart surgery, abdominal surgery, intracranial surgery, or surgery for more than 3 hours, etc.) * 5.Pregnancy * 6.Have a serious concomitant disease * 7.Unable to follow-up * 8.History of severe allergic reactions or allergy to saline and serum * 9.Already participated in another clinical study within 12 weeks * 10.Pulmonary edema caused by other underlying diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PaO2/FiO2 | Day 3 | Oxygenation index |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the days of ventialtion and hospital stay | Day 3 | the length of ventilation and hospital stay |
Other
| Measure | Time frame | Description |
|---|---|---|
| IL-6 | Day 1 | inflammatory factors |
| IL-8 | Day 1 | inflammatory factors |
| TNF-a | Day 3 | inflammatory factors |
Countries
China
Outcome results
None listed