Official Title
Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
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).

Not yet recruiting
ARDS
COVID-19

Biological: MSC

infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells

Eligibility 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

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
Germany
Locations

University Hospital Tuebingen
Tuebingen, Germany

Investigator: Peter Rosenberger, MD

Investigator: Peter Rosenberger, MD

Contacts

Peter Rosenberger, Prof.
+49707129 - 86622
peter.rosenberger@med.uni-tuebingen.de

Peter Rosenberger, Prof., Principal Investigator
University hospital Tübingen

University Hospital Tuebingen
NCT Number
MeSH Terms
COVID-19
Inflammation