Mesenchymal Stem Cell in Patients With Acute Severe Respiratory Failure
NCT ID: NCT02112500
Last Updated: 2016-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
10 participants
INTERVENTIONAL
2014-02-28
2016-12-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Mesenchymal Stem Cell Infusion
Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
80 Years
ALL
No
Sponsors
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Asan Medical Center
OTHER
Responsible Party
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Sang Bum Hong
MD, Professor of Ulsan University College of Medicine
Principal Investigators
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Sang Bum Hong, M.D.
Role: PRINCIPAL_INVESTIGATOR
Asan Medical Center
Locations
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Asan Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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STELLAR-Pilot
Identifier Type: -
Identifier Source: org_study_id
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