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

University Hospital Tuebingen40 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

ARDS COVID-19

Interventions

MSCBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Tuebingen

Tübingen, Germany

Outcomes

Primary Outcomes

lung injury score

improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points

Time frame: day 10