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).
Biological: MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
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
University Hospital Tuebingen
Tuebingen, Germany
Investigator: Peter Rosenberger, MD
Investigator: Peter Rosenberger, MD
Peter Rosenberger, Prof.
+49707129 - 86622
peter.rosenberger@med.uni-tuebingen.de
Peter Rosenberger, Prof., Principal Investigator
University hospital Tübingen