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To evaluate the safety, toxicity and immunological effects of infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells (MSCs) and whether this therapy has an influence on the resolution processes in ARDS patients infected with Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC Treatment | Experimental |
| |
| control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC | Biological | infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| lung injury score | improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points | day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| D-dimers | D-dimers blood levels | day 0, 1, 2, 3, 10 and 15 |
| phenotype | distribution of phenotypes of immune cells | day 0, 1, 2, 3, 10 and 15 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Peter Rosenberger, Prof. | Contact | +49707129 | 86622 | peter.rosenberger@med.uni-tuebingen.de |
| Name | Affiliation | Role |
|---|---|---|
| Peter Rosenberger, Prof. | University Hospital Tübingen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Tuebingen | Tübingen | 72076 | Germany |
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| pro-resolving lipid mediators | Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage | day 0, 1, 2, 3, 10 and 15 |
| cytokines | Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions | day 0, 1, 2, 3, 10 and 15 |
| chemokines | Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions | day 0, 1, 2, 3, 10 and 15 |
| Survival | Survival at 10 days and 28 days | day 10 and 28 |
| extubation | Time to removal of endotracheal tube | day 28 |
| lymphocyte subpopulations | lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10) | day 0, 3, 5 and 10 |
| SARS-CoV-2-specific antibody titers | evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion. | day 0, 5 and 10 |
| complement molecules (C5-C9) | evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion | day 0, 5 and 10 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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