Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Study Details
Study Description
Brief Summary
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MSC Treatment
|
Biological: MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
|
| No Intervention: control
|
Outcome Measures
Primary Outcome Measures
- lung injury score [day 10]
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
Secondary Outcome Measures
- D-dimers [day 0, 1, 2, 3, 10 and 15]
D-dimers blood levels
- phenotype [day 0, 1, 2, 3, 10 and 15]
distribution of phenotypes of immune cells
- pro-resolving lipid mediators [day 0, 1, 2, 3, 10 and 15]
Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage
- cytokines [day 0, 1, 2, 3, 10 and 15]
Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
- chemokines [day 0, 1, 2, 3, 10 and 15]
Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
- Survival [day 10 and 28]
Survival at 10 days and 28 days
- extubation [day 28]
Time to removal of endotracheal tube
- lymphocyte subpopulations [day 0, 3, 5 and 10]
lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)
- SARS-CoV-2-specific antibody titers [day 0, 5 and 10]
evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.
- complement molecules (C5-C9) [day 0, 5 and 10]
evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion
Eligibility Criteria
Criteria
Inclusion Criteria:
-
COVID-19-positive subject
-
Horowitz index ≤ 200
-
Bilateral opacities on frontal chest radiograph, and
-
requirement for positive pressure ventilation via an endotracheal tube or non-invasive ventilation
-
no clinical signs of left atrial hypertension detected via echocardiography, or if measured, a Pulmonary Arterial Wedge Pressure (PAOP) less than or equal to 18 mmHg.
-
Subject's Age ≥ 18 years
Exclusion Criteria:
-
COVID-19-negative subject
-
Subject's Age < 18 years
-
More than 7 days since initiation of mechanical ventilation
-
Patient, surrogate or physician not committed to full intensive care support.
-
Positive Pregnancy test at the time of screening.
-
Patients dependent on the sponsor, investigator and their employees, as well as persons dependent on the manufacturer of the investigational drug
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital Tuebingen | Tuebingen | Germany | 72076 |
Sponsors and Collaborators
- University Hospital Tuebingen
Investigators
- Principal Investigator: Peter Rosenberger, Prof., University hospital Tübingen
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RESCOVID