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

COVID-19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04377334
• Other study ID #: RESCOVID
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: May 2022
• Est. completion date: February 2023

Study information

• Verified date: January 2022
• Source: University Hospital Tuebingen
• Contact: Peter Rosenberger, Prof.
• Phone: +49707129
• Email: peter.rosenberger[@]med.uni-tuebingen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: February 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS
• COVID-19
• Inflammation

Intervention

Biological:
• MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells

Locations

Country	Name	City	State
Germany	University Hospital Tuebingen	Tuebingen

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Tuebingen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	lung injury score	improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points	day 10
Secondary	D-dimers	D-dimers blood levels	day 0, 1, 2, 3, 10 and 15
Secondary	phenotype	distribution of phenotypes of immune cells	day 0, 1, 2, 3, 10 and 15
Secondary	pro-resolving lipid mediators	Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage	day 0, 1, 2, 3, 10 and 15
Secondary	cytokines	Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions	day 0, 1, 2, 3, 10 and 15
Secondary	chemokines	Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions	day 0, 1, 2, 3, 10 and 15
Secondary	Survival	Survival at 10 days and 28 days	day 10 and 28
Secondary	extubation	Time to removal of endotracheal tube	day 28
Secondary	lymphocyte subpopulations	lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)	day 0, 3, 5 and 10
Secondary	SARS-CoV-2-specific antibody titers	evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.	day 0, 5 and 10
Secondary	complement molecules (C5-C9)	evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion	day 0, 5 and 10