Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Respiratory Distress Syndrome, Adult
- Sponsor
- Karolinska University Hospital
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- In-hospital mortality
- Last Updated
- 11 years ago
Overview
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.
Investigators
Karl-Henrik Grinnemo
MD, PhD
Karolinska University Hospital
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
- Not provided
Outcomes
Primary Outcomes
In-hospital mortality
Time Frame: During hospital stay, an expected average 2 months
Secondary Outcomes
- 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)