Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
NCT ID: NCT04377334
Last Updated: 2022-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2022-05-31
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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MSC Treatment
MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
control
No interventions assigned to this group
Interventions
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MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Hospital Tuebingen
OTHER
Responsible Party
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Principal Investigators
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Peter Rosenberger, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Tübingen
Locations
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University Hospital Tuebingen
Tübingen, , Germany
Countries
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Central Contacts
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Facility Contacts
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Peter Rosenberger, MD
Role: primary
Other Identifiers
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RESCOVID
Identifier Type: -
Identifier Source: org_study_id
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