Application of hUC-MSCs in Treating Acute Lung Injury: a Single Center Prospective Clinical Research

Study Overview
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Brief Summary
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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.

Official Title
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Transplatation of Human Umbilcal Cord Derived Mesenchyamal Stem Cells in Acute Lung Injury: a Single Center Prospective Clinical Research

Conditions
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Acute Lung Injury

Intervention / Treatment
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* Biological: human derived umbilical cord derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: hUC-MSCs treatment<br>Patients of acute lung injury will be treated by suspention of hUC-MSCs and albumin combined with standard therapies. | Biological: human derived umbilical cord derived mesenchymal stem cells<br>* intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells<br>|
| No Intervention: non-cell therapy<br>Patients of acute lung injury will be treated by vehicle (albumin) combined with standard therapies. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PaO2/FiO2 | Oxygenation index | Day 3 | 
| PaO2/FiO2 | Oxygenation index | Day 7 | 
| PaO2/FiO2 | Oxygenation index | Day 14 | 
| PaO2/FiO2 | Oxygenation index | Day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the days of ventialtion and hospital stay | the length of ventilation and hospital stay | Day 3 | 
| the days of ventialtion and hospital stay | the length of ventilation and hospital stay | Day 7 | 
| the days of ventialtion and hospital stay | the length of ventilation and hospital stay | Day 14 | 
| the days of ventialtion and hospital stay | the length of ventilation and hospital stay | Day 28 |