Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells
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ClinicalTrials.gov Identifier: NCT02215811 |
Recruitment Status : Unknown
Verified August 2014 by Karl-Henrik Grinnemo, Karolinska University Hospital.
Recruitment status was: Recruiting
First Posted : August 13, 2014
Last Update Posted : August 13, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Respiratory Distress Syndrome, Adult | Biological: Mesenchymal stromal cells | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 10 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Treatment of Severe Acute Respiratory Distress Syndrome With Allogeneic Bone Marrow-derived Mesenchymal Stromal Cells |
Study Start Date : | March 2014 |
Estimated Primary Completion Date : | December 2015 |

Arm | Intervention/treatment |
---|---|
Experimental: Mesenchymal stromal cells |
Biological: Mesenchymal stromal cells |
- In-hospital mortality [ Time Frame: During hospital stay, an expected average 2 months ]
- 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
- Immune modulation [ Time Frame: 3 months ]Change in T-cell, mononuclear cell, cytokine ans microRNA response towards an immunomodulatory phenotype

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02215811
Contact: Karl-Henrik Grinnemo, MD, PhD | +46 70 886 89 68 | karl-henrik.grinnemo@karolinska.se |
Sweden | |
Karolinska University Hospital | Recruiting |
Stockholm, Sweden | |
Contact: Karl-Henrik Grinnemo, MD, PhD +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 University Hospital | Recruiting |
Uppsala, Sweden | |
Contact: Laila Johansson Hellgren, MD, PhD | |
Principal Investigator: Laila Johansson Hellgren, MD, PhD |
Principal Investigator: | Karl-Henrik Grinnemo | Karolinska Institutet |
Responsible Party: | Karl-Henrik Grinnemo, MD, PhD, Karolinska University Hospital |
ClinicalTrials.gov Identifier: | NCT02215811 |
Other Study ID Numbers: |
MSC-ARDS |
First Posted: | August 13, 2014 Key Record Dates |
Last Update Posted: | August 13, 2014 |
Last Verified: | August 2014 |
Extracorporeal membrane oxygenation |
Respiratory Distress Syndrome Respiratory Distress Syndrome, Newborn Acute Lung Injury Syndrome Disease Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Respiration Disorders Infant, Premature, Diseases Infant, Newborn, Diseases Lung Injury |