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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Karolinska University Hospital
Stockholm, Sweden
RECRUITINGUppsala University Hospital
Uppsala, Sweden
RECRUITINGIn-hospital mortality
Time frame: During hospital stay, an expected average 2 months
Pulmonary compliance
Time frame: During ventilator treatment, an expected average of 1 month
Pulmonary tidal volume
Time frame: During ventilator treatment, an expected average of 1 month
Adverse events
I.e infection, fever, effect on end-organ function
Time frame: 6 months
All-cause mortality
Time frame: 12 months
Recovery of organ functions
kidney, liver, heart functions
Time frame: 12 months
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