Status:
COMPLETED
Multiple Dosing of Mesenchymal Stromal Cells in Patients With ARDS (COVID-19)
Lead Sponsor:
Masonic Cancer Center, University of Minnesota
Conditions:
Acute Respiratory Distress Syndrome
ARDS (Moderate or Severe)
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This is a multi-center, randomized, placebo controlled, interventional phase 2A trial to evaluate the safety profile and potential efficacy of multi-dosing of mesenchymal stromal cells (MSC) for patie...
Detailed Description
MSCs are adult, non-hematopoietic precursor cells derived from a variety of tissues (e.g., bone marrow, adipose tissue, and placenta) and have been used as therapy in multiple conditions, especially i...
Eligibility Criteria
Inclusion
- Age 18-80 years
- Meets 'Berlin Criteria' for diagnosis of moderate to severe ARDS for a minimum of 4 hours
- Less than 48 hours on a ventilator after meeting criteria for diagnosis of ARDS
- SARS-CoV-2 (proven by RT-PCR assay) with radiographic infiltrates
- PaO2/FiO2 \< 250
- Positive end-expiratory airway pressure (PEEP) \>5 cm H20
- Elevated C-reactive protein (above laboratory upper limit of normal)
- Meets organ function requirements, including left ventricular ejection fraction (LVEF) \>35% ( as defined below)
- Off other investigational agents directed against inflammatory cytokines 48 hours prior to enrollment; agents directed against the replication of SARS-CoV-2 \[e.g., Remdesivir\] are permitted
- Voluntary informed consent in person or virtually by the patient or patient surrogate considering the face to face limitations during the COVID-19 pandemic and, given the nature of the study population, which frequently requires mechanical ventilation with sedation, surrogate consent will likely occur in a substantial proportion of the study population (this will remain a valid consent until the patient is fully alert, and aware, and can provide a second consent to continue participation in the study).
- Adequate organ function is defined as:
- Renal: Calculated estimated glomerular filtration rate \>30 mL/min/1.73 m2 (on chemistry panel)
- Hepatic: Bilirubin \<3x upper limit of normal (ULN) and AST, ALT and alkaline phosphatase \<5x ULN
- Cardiac: Absence of uncontrolled arrhythmia and LVEF \>35%
Exclusion
- Ventilator support of FiO2 \>0·8 or PEEP \>20 cm H2O and ongoing use of more than two vasopressors for 2 or more hours with any agent at doses shown below in the supine position.
- Norepinephrine \>12 μg/min or 0.2 μg/kg per min
- Phenylephrine \>150 μg/min or 3 μg/kg per min
- Epinephrine \>10 ug/min or 0.2 μg/kg per min
- Vasopressin \>0.04 units/min
- Concurrent use of other investigational agents specifically for treatment of ARDS or inflammatory cytokines. (Note: Agents established to be efficacious and/or those used outside of formal trials are permitted as supportive data emerge)
- Known ineligibility for use of a ventilator for a minimum of 7 days, as judged by the institution's Triage Team
- Known allergy to MSC components: fetal calf serum, human albumin or DMSO
- Active invasive malignant disease requiring chemotherapy/radiation
- Other concurrent life-threatening disease (life expectancy \<6 months) or eligible for hospice care
- Known history of HIV infection on active treatment
- Females who are pregnant or breastfeeding
- Current mean arterial pressure (MAP) \<60 mmHg while on 2 or more vasopressors at above doses for more than 2 hours
- History of any significant cardiac (myocardial infarction within 12 months of screening visit or unstable angina), chronic ongoing hepatic, or renal disease (grade 3 or higher); diagnosis of congestive heart failure with hypoxemia primarily due to decompensated heart failure; diagnosis of severe chronic obstructive pulmonary disease (COPD) or interstitial lung disease requiring supplemental oxygen at home
- Concurrent diagnosis of diffuse alveolar hemorrhage
- Requiring continuous dialysis (unable to stop dialysis during study agent infusion)
Key Trial Info
Start Date :
July 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04466098
Start Date
July 30 2020
End Date
December 31 2024
Last Update
January 29 2025
Active Locations (2)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
2
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261