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

Karolinska University Hospital

Status and phase: Unknown; Phase 1

Conditions: Acute Respiratory Distress Syndrome, Adult

Treatments: Biological: Mesenchymal stromal cells

Study type: Interventional

Funder types: Other

Identifiers

NCT02215811

MSC-ARDS

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Mesenchymal stromal cells

Experimental group

Treatment:

Biological: Mesenchymal stromal cells