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.
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
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Mesenchymal stem cells will be intravenously infused. Mesenchymal stem cells will be cultured and extracted from the bone marrow of the patients.
Asan Medical Center
Seoul, South Korea
RECRUITINGOxygen index at 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)
Time frame: 3 days after mesenchymal stem cell infusion
Lung mechanics
Lung mechanics includes arterial oxygen saturation, tidal volume, minute ventilation, and ratio of PaO2/FiO2.
Time frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
Hemodynamic parameters
Systolic, diastolic, and mean arterial blood pressure Amount of required vasopressor Heart rate
Time frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
Mortality
Death from any cause at 14 and 28 days after mesenchymal stem cell infusion
Time frame: at 14 and 28 days after mesenchymal stem cell infusion
Plasma cytokines
Interleukin (IL)-1, IL-6, IL-8, and IL-10
Time frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
Markers for inflammation and infection
Lactate, DIC score, SOFA score, C-reactive protein, and procalcitonin
Time frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
Ventilator weaning parameters
Failure of ventilator weaning, weaning time, ventilation time
Time frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
ICU and hospital stay
Total duration of ICU stay and hospital stay
Time frame: at 28 days after mesenchymal stem cell infusion