NCT02112500

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Feb 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 30, 2014

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 14, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 11, 2016

Status Verified

January 1, 2016

Enrollment Period

2.8 years

First QC Date

March 30, 2014

Last Update Submit

January 8, 2016

Conditions

Respiratory Distress Syndrome, Adult

Outcome Measures

Primary Outcomes (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)

    3 days after mesenchymal stem cell infusion

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

Mesenchymal Stem Cell Infusion

EXPERIMENTAL

Mesenchymal stem cells cultured and extracted from bone marrow of enrolled patients are infused.

Biological: Mesenchymal Stem Cell

Interventions

Mesenchymal Stem CellBIOLOGICAL

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

Also known as: Lungcellgram
Mesenchymal Stem Cell Infusion

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Asan Medical Center

Seoul, 138-736, South Korea

RECRUITING

Related Publications (11)

  • 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.

    PMID: 17356114BACKGROUND

  • 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.

    PMID: 16236739BACKGROUND

  • 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.

    PMID: 20384521BACKGROUND

  • 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.

    PMID: 19691441BACKGROUND

  • 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.

    PMID: 17212702BACKGROUND

  • 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.

    PMID: 17641052BACKGROUND

  • 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.

    PMID: 19721001BACKGROUND

  • 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.

    PMID: 17569781BACKGROUND

  • 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.

    PMID: 19497992BACKGROUND

  • 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.

    PMID: 15891110BACKGROUND

  • 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.

    PMID: 18508443BACKGROUND

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Study Officials

  • Sang Bum Hong, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Bum Hong, MD

CONTACT

+82-10-6824-9767hongsangbum@gmail.com

Dong Hyun Lee, MD

CONTACT

+82-10-6476-0706rvotvt@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Professor of Ulsan University College of Medicine

Study Record Dates

First Submitted

March 30, 2014

First Posted

April 14, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 11, 2016

Record last verified: 2016-01

Locations

KR(1)