Back to resultsMesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Primary Purpose
ARDS, COVID-19
Status
Not yet recruiting
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
MSC
Sponsored by
About this trial
This is an interventional treatment trial for ARDS
Eligibility Criteria
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
Sites / Locations
- University Hospital Tuebingen
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
MSC Treatment
control
Arm Description
Outcomes
Primary Outcome Measures
lung injury score
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
Secondary Outcome Measures
D-dimers
D-dimers blood levels
phenotype
distribution of phenotypes of immune cells
pro-resolving lipid mediators
Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage
cytokines
Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
chemokines
Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Survival
Survival at 10 days and 28 days
extubation
Time to removal of endotracheal tube
lymphocyte subpopulations
lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)
SARS-CoV-2-specific antibody titers
evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.
complement molecules (C5-C9)
evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion
Full Information
NCT ID
NCT04377334
First Posted
April 16, 2020
Last Updated
January 26, 2022
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04377334
Brief Title
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
Official Title
Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
February 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ARDS, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MSC Treatment
Arm Type
Experimental
Arm Title
control
Arm Type
No Intervention
Intervention Type
Biological
Intervention Name(s)
MSC
Intervention Description
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
Primary Outcome Measure Information:
Title
lung injury score
Description
improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points
Time Frame
day 10
Secondary Outcome Measure Information:
Title
D-dimers
Description
D-dimers blood levels
Time Frame
day 0, 1, 2, 3, 10 and 15
Title
phenotype
Description
distribution of phenotypes of immune cells
Time Frame
day 0, 1, 2, 3, 10 and 15
Title
pro-resolving lipid mediators
Description
Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage
Time Frame
day 0, 1, 2, 3, 10 and 15
Title
cytokines
Description
Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Time Frame
day 0, 1, 2, 3, 10 and 15
Title
chemokines
Description
Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions
Time Frame
day 0, 1, 2, 3, 10 and 15
Title
Survival
Description
Survival at 10 days and 28 days
Time Frame
day 10 and 28
Title
extubation
Description
Time to removal of endotracheal tube
Time Frame
day 28
Title
lymphocyte subpopulations
Description
lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)
Time Frame
day 0, 3, 5 and 10
Title
SARS-CoV-2-specific antibody titers
Description
evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.
Time Frame
day 0, 5 and 10
Title
complement molecules (C5-C9)
Description
evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion
Time Frame
day 0, 5 and 10
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Rosenberger, Prof.
Phone
+49707129
Ext
86622
Email
peter.rosenberger@med.uni-tuebingen.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Rosenberger, Prof.
Organizational Affiliation
University hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Tuebingen
City
Tuebingen
ZIP/Postal Code
72076
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Rosenberger, MD
First Name & Middle Initial & Last Name & Degree
Peter Rosenberger, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mesenchymal Stem Cells (MSCs) in Inflammation-Resolution Programs of Coronavirus Disease 2019 (COVID-19) Induced Acute Respiratory Distress Syndrome (ARDS)
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