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

NCT03608592 | Unknown

• 1 other identifier: QHJH201804
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Respiratory Distress Syndrome

Keywords

refractory acuter respiratory distress syndrome; mesenchymal stem cells; salvage therapy

Outcome Measures

Primary Outcomes (2)

• Infusion associated events

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

  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

  In 60 days after enrolled

Secondary Outcomes (7)

• Ventilation free days(VFDs)

  From the day of UCMSCs use(day 0) to day 28

• Oxygenation index(OI) changes

  From day 0 to day 7, each day

• Lung injury score(LIS)

  From day 0 to day 7, day0,1,3,7

• Positive end expiratory pressure(PEEP)

  From day 0 to day 7, each day

• Plateau pressure(Pplat)

  From day 0 to day 7, each day

Other Outcomes (5)

• Epithelial injury biomarker-KL6

  From day 0 to day 7, day0, 1,3,7

• Endothelial injury biomarker-Ang2

  From day 0 to day 7, day0, 1,3,7

• Tumor necrosis factor a(TNFa)

  From day 0 to day 7, day0, 1,3,7

Study Arms (1)

UCMSCs group

EXPERIMENTAL

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

Biological: umbilical cord derived mesenchymal stem cells (UCMSCs) suspension; Biological: normal saline

Interventions

umbilical cord derived mesenchymal stem cells (UCMSCs) suspension 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.

UCMSCs group

normal saline 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.

UCMSCs group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged≥18 years old;
• 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.

You may not qualify if:

• Any malignant disease;
• Cardiogenic pulmonary edema;
• Over 50% atelectasis either lung lobe in X-ray;
• Pregnancy or perinatal or lactation;
• Previous end stage respiratory disease;
• More than 3 organs failure;
• Liver failure with MELD(Model For End-Stage Liver Disease) score\>40;
• Stage III or IV pulmonary hypertension;
• None invasive arterial and central venous catheter;
• Concurrent deep venous thrombus or pulmonary embolism in 3 months;
• Cerebral hernia;
• More than 96 hours after ARDS onset.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Huimin Yi

Guangzhou, Guangdong, 510630, China

RECRUITING

MeSH Terms

Conditions

Respiratory Distress Syndrome

Interventions

Suspensions; Saline Solution

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Intervention Hierarchy (Ancestors)

Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Crystalloid Solutions; Isotonic Solutions; Solutions

Study Officials

• Huimin Yi

  The 3rd affiliated hospital of Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huimin Yi, Doctor

CONTACT

86-020-85252673; ylhmin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: attending physician

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

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 1, 2018
• Study Start: June 1, 2018
• Primary Completion: August 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 4, 2019

Record last verified: 2019-08

Locations

CN (1)