Human Umbilical Cord Mesenchymal Stem Cells (MSCs) Therapy in ARDS

Sun Yat-sen University26 enrolled

Overview

Acute respiratory distress syndrome (ARDS) is a devastating inflammatory and destructive disease in critical ill patients. Preclinical studies have shown a promising perspective of mesenchymal stem cells (MSCs) therapies in ARDS. But the safety and efficacy of umbilical cord MSCs (UCMSCs) have not yet been convinced in clinical trails. This study will explore the safety and life-rescue potential of UCMSCs in refracotry ARDS.

This is a single arm study. According Berlin definition (2012), moderate or severe adult ARDS patients who fail to improve oxygenation (PaO2/FiO2 increase over 20%) in the first 24h or 8h after diagnosis will be enrolled. A salvage package of 10\^6/kg suspended UCMSCs in 100ml normal saline or only 100ml normal saline will be infused through central venous catheter. Infusion associated events (IAEs) in 24 hours will be closely monitored. Compared with propensity score matched controls, mortality in 28 days as the primary outcomes. oxygenation index, ventilator parameters, lung injury biomarkers and clinical outcomes as secondary outcomes will be analyzed. This is a revised trail from its previous registered pilot RCT, approved by Ethic Committe of Stem Cells Trails (ECSCT) of 3rd affiliated hospital of Sun Yat-Sen university

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Respiratory Distress Syndrome

Interventions

umbilical cord derived mesenchymal stem cells (UCMSCs) suspensionBIOLOGICAL

Clinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours.

normal salineBIOLOGICAL

A bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged≥18 years old; 2. Including all the criteria: (1) Invasive ventilation, OI（PaO2/FiO2）\<200; (2) PEEP≥8cmH2O; (3) Bilateral infiltration of lung in X-ray or CT; (4) In 1 week after onset; (5) Still OI\<200 after protective ventilation or conservative fluid management. Exclusion Criteria: 1. Any malignant disease; 2. Cardiogenic pulmonary edema; 3. Over 50% atelectasis either lung lobe in X-ray; 4. Pregnancy or perinatal or lactation; 5. Previous end stage respiratory disease; 6. More than 3 organs failure; 7. Liver failure with MELD(Model For End-Stage Liver Disease) score\>40; 8. Stage III or IV pulmonary hypertension; 9. None invasive arterial and central venous catheter; 10. Concurrent deep venous thrombus or pulmonary embolism in 3 months; 11. Cerebral hernia; 12. More than 96 hours after ARDS onset.

Locations (1)

Huimin Yi

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

Infusion associated events

Incidence of prescribed adverse events or unprescribed events agreed by investigators and consultant .

Time frame: From infusion beginning to the second day, 24 hours

Mortality

All cause mortality. Cause of death, exact survival status (death/survival) and time (days) will also be recorded

Time frame: In 60 days after enrolled

Secondary Outcomes

Ventilation free days(VFDs)

The days without invasive ventilator support(at least 2 consecutive calendar days) in 28 days. If the ventilator weaned multiple times, VFDs is the sum of the days without ventilator support. If any of following occurring in 28 days, VFDs equals 0: 1. The patient dies in 28 days; 2. Ventilator never be weaned; 3. Censored case with ventilator never being weaned.

Time frame: From the day of UCMSCs use(day 0) to day 28

Oxygenation index(OI) changes

The oxygenation index(OI)=partial pressure of oxygen in arterial blood(PaO2) divide inspiration fraction of oxygen(FiO2). OI is measured at day0, day1,day3,day7.

Time frame: From day 0 to day 7, each day

Lung injury score(LIS)

Murray lung injury scores (LIS) consist of the following 4 parts: A.Hypoxemia (PaO2/FiO2≥300, 225-299,175-224,100-174,\<100, assigned 0,1,2,3,4 scores respectively); B.PEEP (cmH2O) (≤5,6-8,9-11,11-14,≥15, assigned 0,1,2,3,4 scores respectively) ; C.Compliance (ml/cmH2O)(≥80,60-79,40-59,20-39,≤19, assigned 0,1,2,3,4 scores respectively); D.Quadrants infiltrated in Chest X-Ray(CXR) (0,1,2,3,4, assigned 0,1,2,3,4 scores respectively). The total LIS score is obtained by dividing the total sum of points by the number of criteria present. For example, if only 3 criteria are answered to, the total sum is divided by 3 to reveal the final score. The LIS score ranges between 0 and 4, with scores closer to 4 indicating severe acute lung injury.

Central Contacts

Huimin Yi, Doctor

CONTACT

86-020-85252673 ylhmin@hotmail.com

Data from ClinicalTrials.gov

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