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Respiratory Distress Syndrome, AdultPhase 2STELLARNCT02112500

Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure

A Phase 2 study testing Mesenchymal Stem Cell in people with Respiratory Distress Syndrome, Adult, run by Asan Medical Center at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Respiratory Distress Syndrome, Adult
What is being tested?
Mesenchymal Stem Cell
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteSouth Korea
Study dates
Feb 2014to Dec 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 10Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Sang Bum Hong, MD contact

+82-10-6824-9767

hongsangbum@gmail.com

Dong Hyun Lee, MD contact

+82-10-6476-0706

rvotvt@gmail.com

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul, 138-736

    Sang Bum Hong, MD, +82-10-6824-9767, hongsangbum@gmail.com

    Sang Bum Hong, MD

    Recruiting

Other trials in South Korea

About this study

Official title: 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.

Read the 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.

Being tested
Mesenchymal Stem Cell
Medical subject headings
Respiratory Distress Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mesenchymal Stem CellBiological

    Also called Lungcellgram

    Mesenchymal stem cells will be intravenously infused. Mesenchymal stem cells will be cultured and extracted from the bone marrow of the patients.

Study groups in NCT02112500
Study groupRoleWhat they receive
Mesenchymal Stem Cell InfusionExperimentalMesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.
Receives: Biological: Mesenchymal Stem Cell

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oxygen 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)

    Measured: 3 days after mesenchymal stem cell infusion

Secondary outcomes (7)

  1. Lung mechanics

    Lung mechanics includes arterial oxygen saturation, tidal volume, minute ventilation, and ratio of PaO2/FiO2.

    Measured: at 3, 14, and 28 days after mesenchymal stem cell infusion

  2. Hemodynamic parameters

    Systolic, diastolic, and mean arterial blood pressure Amount of required vasopressor Heart rate

    Measured: at 3, 14, and 28 days after mesenchymal stem cell infusion

  3. Mortality

    Death from any cause at 14 and 28 days after mesenchymal stem cell infusion

    Measured: at 14 and 28 days after mesenchymal stem cell infusion

  4. Plasma cytokines

    Interleukin (IL)-1, IL-6, IL-8, and IL-10

    Measured: at 3, 14, and 28 days after mesenchymal stem cell infusion

  5. Markers for inflammation and infection

    Lactate, DIC score, SOFA score, C-reactive protein, and procalcitonin

    Measured: at 3, 14, and 28 days after mesenchymal stem cell infusion

  6. Ventilator weaning parameters

    Failure of ventilator weaning, weaning time, ventilation time

    Measured: at 3, 14, and 28 days after mesenchymal stem cell infusion

  7. ICU and hospital stay

    Total duration of ICU stay and hospital stay

    Measured: at 28 days after mesenchymal stem cell infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02112500
Sponsor's protocol ID
STELLAR-Pilot
Acronym
STELLAR
Status last verified
Jan 2016
First submitted
30 Mar 2014
Last updated
11 Jan 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • Calfee CS, Matthay MA. Nonventilatory treatments for acute lung injury and ARDS. Chest. 2007 Mar;131(3):913-920. doi: 10.1378/chest.06-1743.

    PubMed 17356114

  • Rubenfeld GD, Caldwell E, Peabody E, Weaver J, Martin DP, Neff M, Stern EJ, Hudson LD. Incidence and outcomes of acute lung injury. N Engl J Med. 2005 Oct 20;353(16):1685-93. doi: 10.1056/NEJMoa050333.

    PubMed 16236739

  • D'Agostino B, Sullo N, Siniscalco D, De Angelis A, Rossi F. Mesenchymal stem cell therapy for the treatment of chronic obstructive pulmonary disease. Expert Opin Biol Ther. 2010 May;10(5):681-7. doi: 10.1517/14712591003610614.

    PubMed 20384521

  • Lee JW, Gupta N, Serikov V, Matthay MA. Potential application of mesenchymal stem cells in acute lung injury. Expert Opin Biol Ther. 2009 Oct;9(10):1259-70. doi: 10.1517/14712590903213651.

    PubMed 19691441

  • Stagg J. Immune regulation by mesenchymal stem cells: two sides to the coin. Tissue Antigens. 2007 Jan;69(1):1-9. doi: 10.1111/j.1399-0039.2006.00739.x.

    PubMed 17212702

  • Gupta N, Su X, Popov B, Lee JW, Serikov V, Matthay MA. Intrapulmonary delivery of bone marrow-derived mesenchymal stem cells improves survival and attenuates endotoxin-induced acute lung injury in mice. J Immunol. 2007 Aug 1;179(3):1855-63. doi: 10.4049/jimmunol.179.3.1855.

    PubMed 17641052

  • Lee JW, Fang X, Gupta N, Serikov V, Matthay MA. Allogeneic human mesenchymal stem cells for treatment of E. coli endotoxin-induced acute lung injury in the ex vivo perfused human lung. Proc Natl Acad Sci U S A. 2009 Sep 22;106(38):16357-62. doi: 10.1073/pnas.0907996106. Epub 2009 Aug 31.

    PubMed 19721001

  • Ortiz LA, Dutreil M, Fattman C, Pandey AC, Torres G, Go K, Phinney DG. Interleukin 1 receptor antagonist mediates the antiinflammatory and antifibrotic effect of mesenchymal stem cells during lung injury. Proc Natl Acad Sci U S A. 2007 Jun 26;104(26):11002-7. doi: 10.1073/pnas.0704421104. Epub 2007 Jun 14.

    PubMed 17569781

  • Moodley Y, Atienza D, Manuelpillai U, Samuel CS, Tchongue J, Ilancheran S, Boyd R, Trounson A. Human umbilical cord mesenchymal stem cells reduce fibrosis of bleomycin-induced lung injury. Am J Pathol. 2009 Jul;175(1):303-13. doi: 10.2353/ajpath.2009.080629. Epub 2009 Jun 4.

    PubMed 19497992

  • Rojas M, Xu J, Woods CR, Mora AL, Spears W, Roman J, Brigham KL. Bone marrow-derived mesenchymal stem cells in repair of the injured lung. Am J Respir Cell Mol Biol. 2005 Aug;33(2):145-52. doi: 10.1165/rcmb.2004-0330OC. Epub 2005 May 12.

    PubMed 15891110

  • Zhen G, Liu H, Gu N, Zhang H, Xu Y, Zhang Z. Mesenchymal stem cells transplantation protects against rat pulmonary emphysema. Front Biosci. 2008 May 1;13:3415-22. doi: 10.2741/2936.

    PubMed 18508443

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Mesenchymal Stem Cell in people with Respiratory Distress Syndrome, Adult, run by Asan Medical Center at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sang Bum Hong, MD (+82-10-6824-9767, hongsangbum@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oxygen index at 3 days after mesenchymal stem cell infusion (time frame: 3 days after mesenchymal stem cell infusion). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02112500, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.

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