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Trial record 1 of 1 for:    NCT02112500
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Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure (STELLAR)

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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome, Adult Biological: Mesenchymal Stem Cell Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study for the Efficacy and Safety of Mesenchymal Stem Cell in Acute Severe Respiratory Failure.
Study Start Date : February 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal Stem Cell Infusion
Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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

  5. 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

  6. Ventilator weaning parameters [ Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion ]
    Failure of ventilator weaning, weaning time, ventilation time

  7. ICU and hospital stay [ Time Frame: at 28 days after mesenchymal stem cell infusion ]
    Total duration of ICU stay and hospital stay


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02112500


Contacts
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Contact: Sang Bum Hong, MD +82-10-6824-9767 hongsangbum@gmail.com
Contact: Dong Hyun Lee, MD +82-10-6476-0706 rvotvt@gmail.com

Locations
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Korea, Republic of
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Sang Bum Hong, MD    +82-10-6824-9767    hongsangbum@gmail.com   
Principal Investigator: Sang Bum Hong, MD         
Sponsors and Collaborators
Asan Medical Center
Investigators
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Principal Investigator: Sang Bum Hong, M.D. Asan Medical Center
More Information
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Publications:

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Responsible Party: Sang Bum Hong, MD, Professor of Ulsan University College of Medicine, Asan Medical Center
ClinicalTrials.gov Identifier: NCT02112500    
Other Study ID Numbers: STELLAR-Pilot
First Posted: April 14, 2014    Key Record Dates
Last Update Posted: January 11, 2016
Last Verified: January 2016
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Insufficiency
Acute Lung Injury
Lung Diseases
 Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury