Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury

Study Overview
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Brief Summary
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Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.

Detailed Description
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Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study. Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects. The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days. Clinical results will be analyzed after completion of 14 days of followup.

Official Title
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Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury

Conditions
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Acute Lung Injury, Acute Respiratory Distress Syndrome

Intervention / Treatment
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* Biological: UCMSC group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent Age between 35 and 70 y Acute onset within 7 days. Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg Bilateral infiltrates on chest radiography No cardiac failure Exclusion Criteria: Declined to sign informed consent Socially and mentally disabilities Malignant diseases Combined with severe infectious diseases Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening Pregnant or perinatal women Severe diseases of any major organs

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: UCMSC group<br>Human umbilical cord MSCs are administrated to patients by intravenous infusion | Biological: UCMSC group<br>* Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety will be determined by the assessment of major adverse events | Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion. | From day 0 at the start of treatment to day 14. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantify pulmonary respiratory function measured by chest computerized tomography |  | Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. | 
| The efficacy of UC-MSC treatment was measured by arterial blood gas analysis |  | Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14. | 
| The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6 |  | 6 hours post-infusion, and days 1, 2, and 3 | 
| The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8 |  | 6 hours post-infusion, and days 1, 2, and 3 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, ALI, cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation