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Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells

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ClinicalTrials.gov Identifier: NCT02215811
Recruitment Status : Unknown
Verified August 2014 by Karl-Henrik Grinnemo, Karolinska University Hospital.
Recruitment status was:  Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Karl-Henrik Grinnemo, Karolinska University Hospital

Study Description
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Brief Summary:
This is a multi-center, open-label, non-randomized controlled trial. Patients with viral-induced acute respiratory distress syndrome (ARDS) on extracorporeal membrane oxygenation (ECMO) will be eligible. Ten patients will be enrolled and receive allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC). Ventilator parameters as well as preoperative clinical characteristics and postoperative clinical outcomes will be registered. Routine blood sampling, radiography, and bronchioalveolar lavage will be performed pre- and postoperatively. Spirometry, quality of life assessment, and 6 minute walk test will be performed postoperatively. All available data will be collected prospectively. Follow-up is 12 months. Informed consent will be obtained from relatives to patients meeting the inclusion criteria before the initiation of any study-specific procedures.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome, Adult Biological: Mesenchymal stromal cells Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Study Start Date : March 2014
Estimated Primary Completion Date : December 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Mesenchymal stromal cells Biological: Mesenchymal stromal cells


Outcome Measures
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Primary Outcome Measures :
  1. In-hospital mortality [ Time Frame: During hospital stay, an expected average 2 months ]

Secondary Outcome Measures :
  1. Pulmonary compliance [ Time Frame: During ventilator treatment, an expected average of 1 month ]
  2. Pulmonary tidal volume [ Time Frame: During ventilator treatment, an expected average of 1 month ]
  3. Adverse events [ Time Frame: 6 months ]
    I.e infection, fever, effect on end-organ function

  4. All-cause mortality [ Time Frame: 12 months ]
  5. Recovery of organ functions [ Time Frame: 12 months ]
    kidney, liver, heart functions


Other Outcome Measures:
  1. Immune modulation [ Time Frame: 3 months ]
    Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • ≥ 18 years of age
  • Viral-induced acute respiratory distress syndrome
  • Ventilator treatment
  • Extracorporeal membrane oxygenation treatment
  • Relatives provide written informed consent

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215811


Contacts
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Contact: Karl-Henrik Grinnemo, MD, PhD +46 70 886 89 68 karl-henrik.grinnemo@karolinska.se

Locations
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Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden
Contact: Karl-Henrik Grinnemo, MD, PhD    +46 70 886 89 68      
Principal Investigator: Karl-Henrik Grinnemo, MD, PhD         
Sub-Investigator: Katarina Le Blanc, MD, PhD         
Sub-Investigator: Magnus Dalén, MD         
Sub-Investigator: Oscar E Simonson, MD         
Uppsala University Hospital Recruiting
Uppsala, Sweden
Contact: Laila Johansson Hellgren, MD, PhD         
Principal Investigator: Laila Johansson Hellgren, MD, PhD         
Sponsors and Collaborators
Karolinska University Hospital
Karolinska Institutet
Investigators
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Principal Investigator: Karl-Henrik Grinnemo Karolinska Institutet
More Information
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Responsible Party: Karl-Henrik Grinnemo, MD, PhD, Karolinska University Hospital
ClinicalTrials.gov Identifier: NCT02215811    
Other Study ID Numbers: MSC-ARDS
First Posted: August 13, 2014    Key Record Dates
Last Update Posted: August 13, 2014
Last Verified: August 2014
Keywords provided by Karl-Henrik Grinnemo, Karolinska University Hospital:
Extracorporeal membrane oxygenation
Additional relevant MeSH terms:
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Respiratory Distress Syndrome
Respiratory Distress Syndrome, Newborn
Acute Lung Injury
Syndrome
Disease
Pathologic Processes
 Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury