A Pilot Study for the Efficacy and Safety of Mesenchymal Stem Cell in Acute Severe Respiratory Failure.
Trial Snapshot
- Phase
- Phase 2
- Sponsor
- Asan Medical Center
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Oxygen index at 3 days after mesenchymal stem cell infusion
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Ventilator care from respiratory failure
- •Ventilator care for 7 or more days
- •at least one of the followings
- •PaO2/FiO2 = 200 or less when PEEP 5 cmH2O or more.
- •PaCO2 = 50 mmHg or more when plateau pressure of 30 cmH2O or more.
- •pH = 7.25 or less when plateau pressure of 30 cmH2O or more.
- •No other treatment option except for lung transplantation and not candidate for recipient (organ failure, comorbid infection, economy,...)
- •Ventilatory care with weaning failure 3 times or more
- •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
Arms & Interventions
Mesenchymal Stem Cell Infusion
Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.
Intervention: Mesenchymal Stem Cell (Biological)
Outcomes
Primary Outcomes
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 Outcomes
- Lung mechanics(at 3, 14, and 28 days after mesenchymal stem cell infusion)
- Hemodynamic parameters(at 3, 14, and 28 days after mesenchymal stem cell infusion)
- Mortality(at 14 and 28 days after mesenchymal stem cell infusion)
- Plasma cytokines(at 3, 14, and 28 days after mesenchymal stem cell infusion)
- Markers for inflammation and infection(at 3, 14, and 28 days after mesenchymal stem cell infusion)
- Ventilator weaning parameters(at 3, 14, and 28 days after mesenchymal stem cell infusion)
- ICU and hospital stay(at 28 days after mesenchymal stem cell infusion)
Investigators
Sang Bum Hong
MD, Professor of Ulsan University College of Medicine
Asan Medical Center