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Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure (STELLAR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02112500
Recruitment Status : Unknown
Verified January 2016 by Sang Bum Hong, Asan Medical Center.
Recruitment status was:  Recruiting
First Posted : April 14, 2014
Last Update Posted : January 11, 2016
Sponsor:
Information provided by (Responsible Party):
Sang Bum Hong, Asan Medical Center

Tracking Information
First Submitted Date  ICMJE March 30, 2014
First Posted Date  ICMJE April 14, 2014
Last Update Posted Date January 11, 2016
Study Start Date  ICMJE February 2014
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
Oxygen index at 3 days after mesenchymal stem cell infusion [ Time Frame: 3 days after mesenchymal stem cell infusion ]
Oxygen index at 3 days after mesenchymal stem cell infusion. Oxygen index is calculated as follows; ((FiO2) x (Mean airway pressure)) / (PaO2)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02112500 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2014)
  • Lung mechanics [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Lung mechanics includes arterial oxygen saturation, tidal volume, minute ventilation, and ratio of PaO2/FiO2.
  • Hemodynamic parameters [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Systolic, diastolic, and mean arterial blood pressure Amount of required vasopressor Heart rate
  • Mortality [ Time Frame: at 14 and 28 days after mesenchymal stem cell infusion ]
    Death from any cause at 14 and 28 days after mesenchymal stem cell infusion
  • Plasma cytokines [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Interleukin (IL)-1, IL-6, IL-8, and IL-10
  • Markers for inflammation and infection [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Lactate, DIC score, SOFA score, C-reactive protein, and procalcitonin
  • Ventilator weaning parameters [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Failure of ventilator weaning, weaning time, ventilation time
  • ICU and hospital stay [ Time Frame: at 28 days after mesenchymal stem cell infusion ]
    Total duration of ICU stay and hospital stay
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure
Official Title  ICMJE A Pilot Study for the Efficacy and Safety of Mesenchymal Stem Cell in Acute Severe Respiratory Failure.
Brief Summary

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still high and the life quality is frequently compromised from pulmonary fibrosis.

The investigators hypothesize that the treatment using mesenchymal stem cell can be beneficial in patients with respiratory failure. The present study is a pilot study evaluating the efficacy and safety of mesenchymal stem cell treatment in patients with respiratory failure.

Detailed Description

Although the advent of advanced medical support for respiratory failure, the mortality rate of acute severe respiratory failure is still reported to be more than 40%. The respiratory distress syndrome may develop in all ages resulting in progressive pulmonary fibrosis. A number of survivors from respiratory failure suffer from the sequelas of pulmonary fibrosis.

However, the treatments of respiratory failure are limited to the correction of baseline disease, cardiopulmonary support, and conservative management to minimize the lung injury. There has not been any effective and specific treatment for respirator distress nor medicine to reduce mortality.

There have been reports of mesenchymal stem cell experimental animals with chronic obstructive pulmonary disease, interstitial lung disease, and sepsis. In addition, the mesenchymal stem cell treatment showed beneficial effect in bleomycin endotoxin induced lung injury.

Authors hypothesize that the mesenchymal stem cell treatment in patients with respiratory failure will show efficacy. We would conduct the present pilot study to evaluate the efficacy and safety in patients with respiratory failure and intend to suggest an additional alternative treatment option for those without additional treatment option.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Respiratory Distress Syndrome, Adult
Intervention  ICMJE Biological: Mesenchymal Stem Cell
Mesenchymal stem cells will be intravenously infused. Mesenchymal stem cells will be cultured and extracted from the bone marrow of the patients.
Other Name: Lungcellgram
Study Arms  ICMJE Experimental: Mesenchymal Stem Cell Infusion
Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.
Intervention: Biological: Mesenchymal Stem Cell
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 10, 2014)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2016
Estimated Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Ventilator care from respiratory failure
  • Ventilator care for 7 or more days
  • at least one of the followings

    1. PaO2/FiO2 = 200 or less when PEEP 5 cmH2O or more.
    2. PaCO2 = 50 mmHg or more when plateau pressure of 30 cmH2O or more.
    3. pH = 7.25 or less when plateau pressure of 30 cmH2O or more.
    4. No other treatment option except for lung transplantation and not candidate for recipient (organ failure, comorbid infection, economy,...)
    5. Ventilatory care with weaning failure 3 times or more
    6. Ventilator care requiring 7 days or more from the first self respiration to weaning of ventilator.

      • PEEP, positive endexpiratory pressure

Exclusion Criteria:

  • Severe aplastic anemia
  • Malignant hematologic disorder or history of stem cell treatment.
  • Currently uncontrolled malignancy or history of solid cancer within 2 years
  • HIV Infection
  • Expected life < 3 months from other cause than the respiratory failure
  • Pregnancy or breast feeding
  • Expected hypersensitivity for study drug
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02112500
Other Study ID Numbers  ICMJE STELLAR-Pilot
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sang Bum Hong, Asan Medical Center
Study Sponsor  ICMJE Asan Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang Bum Hong, M.D. Asan Medical Center
PRS Account Asan Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP