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

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ClinicalTrials.gov Identifier: NCT04377334
Recruitment Status : Not yet recruiting
First Posted : May 6, 2020
Last Update Posted : June 7, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital Tuebingen

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).

Condition or disease Intervention/treatment Phase
ARDS COVID-19 Biological: MSC Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Phase II Study: MSCs in Inflammation-Resolution Programs of SARS-CoV-2 Induced ARDS
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : June 2022


Arm Intervention/treatment
Experimental: MSC Treatment Biological: MSC
infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells

No Intervention: control



Primary Outcome Measures :
  1. lung injury score [ Time Frame: day 10 ]
    improvement of lung injury score (LIS), 0-16 points, severity increasing with higher points


Secondary Outcome Measures :
  1. D-dimers [ Time Frame: day 0, 1, 2, 3, 10 and 15 ]
    D-dimers blood levels

  2. phenotype [ Time Frame: day 0, 1, 2, 3, 10 and 15 ]
    distribution of phenotypes of immune cells

  3. pro-resolving lipid mediators [ Time Frame: day 0, 1, 2, 3, 10 and 15 ]
    Levels of specialized pro-resolving lipid mediators within alveolar macrophages and bronchoalveolar lavage

  4. cytokines [ Time Frame: day 0, 1, 2, 3, 10 and 15 ]
    Cytokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions

  5. chemokines [ Time Frame: day 0, 1, 2, 3, 10 and 15 ]
    Chemokine concentration within bronchoalveolar lavage and Serum prior and after MSC infusions

  6. Survival [ Time Frame: day 10 and 28 ]
    Survival at 10 days and 28 days

  7. extubation [ Time Frame: day 28 ]
    Time to removal of endotracheal tube

  8. lymphocyte subpopulations [ Time Frame: day 0, 3, 5 and 10 ]
    lymphocyte subpopulations in peripheral blood by flow cytometry prior and after MSC infusion (day 0,3,5,10)

  9. SARS-CoV-2-specific antibody titers [ Time Frame: day 0, 5 and 10 ]
    evaluate SARS-CoV-2-specific antibody titers in the serum of patients prior and post MSC infusion.

  10. complement molecules (C5-C9) [ Time Frame: day 0, 5 and 10 ]
    evaluate levels of complement molecules (C5-C9) in the serum of patients prior and post MSC infusion



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04377334


Contacts
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Contact: Peter Rosenberger, Prof. +49707129 ext 86622 peter.rosenberger@med.uni-tuebingen.de

Locations
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Germany
University Hospital Tuebingen
Tuebingen, Germany, 72076
Contact: Peter Rosenberger, MD         
Principal Investigator: Peter Rosenberger, MD         
Sponsors and Collaborators
University Hospital Tuebingen
Investigators
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Principal Investigator: Peter Rosenberger, Prof. University hospital Tübingen
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Responsible Party: University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT04377334    
Other Study ID Numbers: RESCOVID
First Posted: May 6, 2020    Key Record Dates
Last Update Posted: June 7, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Inflammation
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Pathologic Processes