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

Study Status: Terminated
Recruit Status: Unknown status
Study Type: Interventional

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

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 Summary:
Sponsor: Karolinska University Hospital

Current Primary Outcome: In-hospital mortality [ Time Frame: During hospital stay, an expected average 2 months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 [ Time Frame: 6 months ]
    I.e infection, fever, effect on end-organ function
  • All-cause mortality [ Time Frame: 12 months ]
  • Recovery of organ functions [ Time Frame: 12 months ]
    kidney, liver, heart functions


Original Secondary Outcome: Same as current

Information By: Karolinska University Hospital

Dates:
Date Received: April 11, 2014
Date Started: March 2014
Date Completion:
Last Updated: August 12, 2014
Last Verified: August 2014