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

January 8, 2016 updated by: Sang Bum Hong, Asan Medical Center

A Pilot Study for the Efficacy and Safety of Mesenchymal Stem Cell in Acute Severe Respiratory Failure.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Dong Hyun Lee, MD
  • Phone Number: +82-10-6476-0706
  • Email: rvotvt@gmail.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • Asan Medical Center
        • Contact:
        • Principal Investigator:
          • Sang Bum Hong, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Lungcellgram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 days after mesenchymal stem cell infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at 3, 14, and 28 days after mesenchymal stem cell infusion
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
at 3, 14, and 28 days after mesenchymal stem cell infusion
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
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
at 3, 14, and 28 days after mesenchymal stem cell infusion
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
at 3, 14, and 28 days after mesenchymal stem cell infusion
Ventilator weaning parameters
Time Frame: at 3, 14, and 28 days after mesenchymal stem cell infusion
Failure of ventilator weaning, weaning time, ventilation time
at 3, 14, and 28 days after mesenchymal stem cell infusion
ICU and hospital stay
Time Frame: at 28 days after mesenchymal stem cell infusion
Total duration of ICU stay and hospital stay
at 28 days after mesenchymal stem cell infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Investigators

  • Principal Investigator: Sang Bum Hong, M.D., Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

March 30, 2014

First Submitted That Met QC Criteria

April 10, 2014

First Posted (Estimate)

April 14, 2014

Study Record Updates

Last Update Posted (Estimate)

January 11, 2016

Last Update Submitted That Met QC Criteria

January 8, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STELLAR-Pilot

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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