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

August 12, 2014 updated by: Karl-Henrik Grinnemo, Karolinska University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Sweden
      • Stockholm, Sweden
        • Recruiting
        • Karolinska University Hospital
        • Contact:
          • Karl-Henrik Grinnemo, MD, PhD
          • Phone Number: +46 70 886 89 68
        • Principal Investigator:
          • Karl-Henrik Grinnemo, MD, PhD
        • Sub-Investigator:
          • Katarina Le Blanc, MD, PhD
        • Sub-Investigator:
          • Magnus Dalén, MD
        • Sub-Investigator:
          • Oscar E Simonson, MD
      • Uppsala, Sweden
        • Recruiting
        • Uppsala University Hospital
        • Contact:
          • Laila Johansson Hellgren, MD, PhD
        • Principal Investigator:
          • Laila Johansson Hellgren, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mesenchymal stromal cells
Biological: Mesenchymal stromal cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
In-hospital mortality
Time Frame: During hospital stay, an expected average 2 months
During hospital stay, an expected average 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause mortality
Time Frame: 12 months
12 months
Pulmonary compliance
Time Frame: During ventilator treatment, an expected average of 1 month
During ventilator treatment, an expected average of 1 month
Pulmonary tidal volume
Time Frame: During ventilator treatment, an expected average of 1 month
During ventilator treatment, an expected average of 1 month
Adverse events
Time Frame: 6 months
I.e infection, fever, effect on end-organ function
6 months
Recovery of organ functions
Time Frame: 12 months
kidney, liver, heart functions
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Immune modulation
Time Frame: 3 months
Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska University Hospital

Collaborators

Karolinska Institutet

Investigators

  • Principal Investigator: Karl-Henrik Grinnemo, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

April 11, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 13, 2014

Study Record Updates

Last Update Posted (Estimate)

August 13, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MSC-ARDS

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Respiratory Distress Syndrome, Adult

Clinical Trials on Mesenchymal stromal cells

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mozambique

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe