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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-01

Study Completion Date

2020-12-01

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

A package of 100ml normal saline with 10\^6/kg umbilical cord derived MSCs suspension will infused from central venous catheter.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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UCMSCs group

Intravenous infusion of 1million UCMSCs per kilogram body weight suspended in 100ml normal saline, infusion duration 30-60min.

Group Type EXPERIMENTAL

umbilical cord derived mesenchymal stem cells (UCMSCs) suspension

Intervention Type BIOLOGICAL

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 saline

Intervention Type BIOLOGICAL

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

Interventions

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umbilical cord derived mesenchymal stem cells (UCMSCs) suspension

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.

Intervention Type BIOLOGICAL

normal saline

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No