Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure

Phase 2

• Conditions: Respiratory Distress Syndrome, Adult
• Interventions: Biological: Mesenchymal Stem Cell

• Registration Number: NCT02112500
• Lead Sponsor: Asan Medical Center

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 Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-30
• Study First Submitted QC: 2014-04-10
• Study First Posted: 2014-04-14
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-08
• Last Update Posted: 2016-01-11
• Primary Completion: 2016-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal Stem Cell Infusion	Mesenchymal Stem Cell	Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.

Primary Outcome Measures

Name	Time	Method
Oxygen index at 3 days after mesenchymal stem cell infusion	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

Name	Time	Method
Lung mechanics	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	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	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	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	at 3, 14, and 28 days after mesenchymal stem cell infusion	Lactate, DIC score, SOFA score, C-reactive protein, and procalcitonin
Ventilator weaning parameters	at 3, 14, and 28 days after mesenchymal stem cell infusion	Failure of ventilator weaning, weaning time, ventilation time
ICU and hospital stay	at 28 days after mesenchymal stem cell infusion	Total duration of ICU stay and hospital stay

Trial Locations

Locations (1)

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of