Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
1 other identifier
interventional
10
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 11, 2014
CompletedFirst Posted
Study publicly available on registry
August 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedAugust 13, 2014
August 1, 2014
1.8 years
April 11, 2014
August 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
In-hospital mortality
During hospital stay, an expected average 2 months
Secondary Outcomes (5)
Pulmonary compliance
During ventilator treatment, an expected average of 1 month
Pulmonary tidal volume
During ventilator treatment, an expected average of 1 month
Adverse events
6 months
All-cause mortality
12 months
Recovery of organ functions
12 months
Other Outcomes (1)
Immune modulation
3 months
Study Arms (1)
Mesenchymal stromal cells
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- ≥ 18 years of age
- Viral-induced acute respiratory distress syndrome
- Ventilator treatment
- Extracorporeal membrane oxygenation treatment
- Relatives provide written informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska University Hospitallead
- Karolinska Institutetcollaborator
Study Sites (2)
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl-Henrik Grinnemo
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD
Study Record Dates
First Submitted
April 11, 2014
First Posted
August 13, 2014
Study Start
March 1, 2014
Primary Completion
December 1, 2015
Last Updated
August 13, 2014
Record last verified: 2014-08