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

Acute Respiratory Distress Syndrome, Adult Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02215811
• Other study ID #: MSC-ARDS
• Status: Recruiting
• Phase: Phase 1
• First received: April 11, 2014
• Last updated: August 12, 2014
• Start date: March 2014

Study information

• Verified date: August 2014
• Source: Karolinska University Hospital
• Contact: Karl-Henrik Grinnemo, MD, PhD
• Phone: +46 70 886 89 68
• Email: karl-henrik.grinnemo[@]karolinska.se
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

Biological:
• Mesenchymal stromal cells

Locations

Country	Name	City	State
Sweden	Karolinska University Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska University Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Immune modulation	Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype	3 months	No
Primary	In-hospital mortality		During hospital stay, an expected average 2 months	Yes
Secondary	Pulmonary compliance		During ventilator treatment, an expected average of 1 month	No
Secondary	Pulmonary tidal volume		During ventilator treatment, an expected average of 1 month	No
Secondary	Adverse events	I.e infection, fever, effect on end-organ function	6 months	Yes
Secondary	All-cause mortality		12 months	Yes
Secondary	Recovery of organ functions	kidney, liver, heart functions	12 months	No