Status:
UNKNOWN
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Lead Sponsor:
University Hospital Tuebingen
Conditions:
ARDS
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04377334
Start Date
May 1 2022
End Date
February 1 2023
Last Update
January 27 2022
Active Locations (1)
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1
University Hospital Tuebingen
Tübingen, Germany, 72076