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

Primary Purpose

Acute Respiratory Distress Syndrome, Adult

Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Mesenchymal stromal cells
Sponsored by
Karolinska University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Respiratory Distress Syndrome, Adult focused on measuring Extracorporeal membrane oxygenation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Karolinska University HospitalRecruiting
  • Uppsala University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stromal cells

Arm Description

Outcomes

Primary Outcome Measures

In-hospital mortality

Secondary Outcome Measures

Pulmonary compliance
Pulmonary tidal volume
Adverse events
I.e infection, fever, effect on end-organ function
All-cause mortality
Recovery of organ functions
kidney, liver, heart functions

Full Information

First Posted
April 11, 2014
Last Updated
August 12, 2014
Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet
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1. Study Identification

Unique Protocol Identification Number
NCT02215811
Brief Title
Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Official Title
Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska University Hospital
Collaborators
Karolinska Institutet

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Respiratory Distress Syndrome, Adult
Keywords
Extracorporeal membrane oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stromal cells
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Mesenchymal stromal cells
Primary Outcome Measure Information:
Title
In-hospital mortality
Time Frame
During hospital stay, an expected average 2 months
Secondary Outcome Measure Information:
Title
Pulmonary compliance
Time Frame
During ventilator treatment, an expected average of 1 month
Title
Pulmonary tidal volume
Time Frame
During ventilator treatment, an expected average of 1 month
Title
Adverse events
Description
I.e infection, fever, effect on end-organ function
Time Frame
6 months
Title
All-cause mortality
Time Frame
12 months
Title
Recovery of organ functions
Description
kidney, liver, heart functions
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Immune modulation
Description
Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karl-Henrik Grinnemo, MD, PhD
Phone
+46 70 886 89 68
Email
karl-henrik.grinnemo@karolinska.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Henrik Grinnemo
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska University Hospital
City
Stockholm
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karl-Henrik Grinnemo, MD, PhD
Phone
+46 70 886 89 68
First Name & Middle Initial & Last Name & Degree
Karl-Henrik Grinnemo, MD, PhD
First Name & Middle Initial & Last Name & Degree
Katarina Le Blanc, MD, PhD
First Name & Middle Initial & Last Name & Degree
Magnus Dalén, MD
First Name & Middle Initial & Last Name & Degree
Oscar E Simonson, MD
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laila Johansson Hellgren, MD, PhD
First Name & Middle Initial & Last Name & Degree
Laila Johansson Hellgren, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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