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

Phase 2

• Conditions: COVID-19; ARDS
• Interventions: Biological: MSC

• Registration Number: NCT04377334
• Lead Sponsor: University Hospital Tuebingen

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-04-16
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-06
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-26
• Last Update Posted: 2022-01-27
• Study Start: 2022-05
• Primary Completion: 2022-11
• Study Completion: 2023-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MSC Treatment	MSC	-

Primary Outcome Measures

Name	Time	Method
lung injury score	day 10	improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points

Secondary Outcome Measures

Name	Time	Method
phenotype	day 0, 1, 2, 3, 10 and 15	distribution of phenotypes of immune cells
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
Survival	day 10 and 28	Survival at 10 days and 28 days
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.
D-dimers	day 0, 1, 2, 3, 10 and 15	D-dimers blood levels
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
extubation	day 28	Time to removal of endotracheal tube
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

Trial Locations

Locations (1)

University Hospital Tuebingen; 🇩🇪 Tuebingen, Germany