Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)

University Hospital Tuebingen

Status and phase

Unknown

Phase 2

Conditions

COVID-19

ARDS

Treatments

Biological: MSC

Study type

Interventional

Funder types

Other

Identifiers

NCT04377334

RESCOVID

Details and patient eligibility

About

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).

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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