Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
1 other identifier
interventional
40
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started May 2022
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 16, 2020
CompletedFirst Posted
Study publicly available on registry
May 6, 2020
CompletedStudy Start
First participant enrolled
May 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2023
CompletedJanuary 27, 2022
January 1, 2022
6 months
April 16, 2020
January 26, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
lung injury score
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
day 10
Secondary Outcomes (10)
D-dimers
day 0, 1, 2, 3, 10 and 15
phenotype
day 0, 1, 2, 3, 10 and 15
pro-resolving lipid mediators
day 0, 1, 2, 3, 10 and 15
cytokines
day 0, 1, 2, 3, 10 and 15
chemokines
day 0, 1, 2, 3, 10 and 15
- +5 more secondary outcomes
Study Arms (2)
MSC Treatment
EXPERIMENTALcontrol
NO INTERVENTIONInterventions
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital Tuebingen
Tübingen, 72076, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Rosenberger, Prof.
University Hospital Tübingen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 16, 2020
First Posted
May 6, 2020
Study Start
May 1, 2022
Primary Completion
November 1, 2022
Study Completion
February 1, 2023
Last Updated
January 27, 2022
Record last verified: 2022-01