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

Phase 1

• Conditions: Acute Respiratory Distress Syndrome, Adult
• Interventions: Biological: Mesenchymal stromal cells

• Registration Number: NCT02215811
• Lead Sponsor: Karolinska University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-11
• Status Verified: 2014-08
• Study First Submitted QC: 2014-08-12
• Last Update Submitted: 2014-08-12
• Study First Posted: 2014-08-13
• Last Update Posted: 2014-08-13
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stromal cells	Mesenchymal stromal cells	-

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	During hospital stay, an expected average 2 months

Secondary Outcome Measures

Name	Time	Method
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	I.e infection, fever, effect on end-organ function
All-cause mortality	12 months
Recovery of organ functions	12 months	kidney, liver, heart functions

Trial Locations

Locations (2)

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden