Back to resultsUse of UC-MSCs for COVID-19 Patients
Primary Purpose
Corona Virus Infection, ARDS, ARDS, Human
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.
Vehicle + Heparin along with best supportive care
Sponsored by
About this trial
This is an interventional treatment trial for Corona Virus Infection focused on measuring COVID-19
Eligibility Criteria
Inclusion Criteria:
Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:
- Patient currently hospitalized
- Aged ≥ 18 years
- Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
- Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
- PaO2/FiO2 ratio < 300 mmHg
- Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
- Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation
Exclusion Criteria:
- PaO2/FiO2 ≥ 300 at the time of enrollment
- A previous MSC infusion not related to this trial
- History of Pulmonary Hypertension (WHO Class III/IV)
- History of left atrial hypertension or decompensated left heart failure.
- Pregnant or lactating patient
- Unstable arrhythmia
- Patients with previous lung transplant
- Patients currently receiving chronic dialysis
- Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
- Presence of any active malignancy (except non-melanoma skin cancer)
- Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
- Moderate to severe liver disease (AST and ALT >5 X ULN)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
- Baseline QT prolongation
- Moribund patient not expected to survive > 24 hours
Sites / Locations
- Diabetes Research Institute, University of Miami Miller School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
UC-MSCs Group
Control Group
Arm Description
Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
Outcomes
Primary Outcome Measures
Number of Participants With Pre-Specified Infusion Associated Adverse Events
Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:
An increase in vasopressor dose greater than or equal to the following:
Norepinephrine: 10 μg/min
Phenylephrine: 100 μg/min
Dopamine: 10 μg/kg/min
Epinephrine: 10 μg/min
In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of >20%.
In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.
New cardiac arrhythmia requiring cardioversion
New ventricular tachycardia, ventricular fibrillation, or asystole
A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
Cardiac arrest or death within 24h post infusion
Number of Subjects With Serious Adverse Events by 31 Days After First Infusion
The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).
Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90
Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Total number of adverse events and serious adverse events as assessed by treating physician
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Total number of adverse events plus serious adverse events categorized by severity.
Subjects With Adverse Events and Serious Adverse Events by Severity
Total number of subjects with adverse events and serious adverse events categorized by severity.
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment
Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.
Subjects With Adverse Events by Relatedness to Treatment
Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional
Secondary Outcome Measures
Survival at 31 Days Post First Infusion
Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.
Survival at 60 Days Post First Infusion
Number of participants alive at 60 days post first infusion follow up.
Time to Recovery
Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Number of days participants were off ventilators during 28 days post second infusion.
Ventilator-Free Days Throughout 90 Days
Number of days participants were off ventilators within up to 90 days of hospitalization.
Respiratory Rate and Oxygenation Index (ROX Index)
Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.
Oxygenation Index (OI)
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen).
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)
Sequential Organ Failure Assessment (SOFA) Scores
Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).
Smell Identification Test (SIT) Scores
SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell
White Blood Cell Count (WBC)
As assessed via serum blood samples.
Platelets Count
As assessed via serum blood samples.
Hemogoblin
Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
Hematocrit
The percentage by volume of red cells in your blood as assessed via serum blood samples.
Neutrophils
the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples
Lymphocytes
Lymphocyte count as assessed via serum blood samples
Glomerular Filtration Rate
Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.
Total Protein
Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.
Sodium
Sodium levels as assessed by serum blood samples.
Potassium
Potassium levels as assessed via serum blood samples.
Creatinine
Creatinine levels as assessed via serum blood samples
Glucose
Glucose levels as assessed via serum blood samples
Albumin
Albumin levels as assessed via serum blood samples
Alkaline Phosphatase
Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples
Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples
Total Bilirubin
Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
Blood Urea Nitrogen (BUN)
Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Calcium
Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
Chloride
Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
Carbon Dioxide (CO2)
Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
C-Reactive Protein Levels
As assessed via serum blood samples.
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
As assessed via serum blood samples on day 6 (visit 8).
D-dimer Levels
As assessed via serum blood samples.
25-Hydroxy Vitamin D Levels
As assessed via serum blood samples.
Tumor Necrosis Factor-alpha (TNFα)
Analysis of TNFα in peripheral blood plasma
Tumor Necrosis Factor-beta (TNFβ)
Analysis of TNFβ in peripheral blood plasma
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
Viral Load by SARS-CoV-2 RT-PCR
Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion
Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04355728
Brief Title
Use of UC-MSCs for COVID-19 Patients
Official Title
Umbilical Cord-derived Mesenchymal Stem Cells for COVID-19 Patients With Acute Respiratory Distress Syndrome (ARDS)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2020 (Actual)
Primary Completion Date
October 31, 2020 (Actual)
Study Completion Date
October 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Camillo Ricordi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this research study is to learn about the safety and efficacy of human umbilical cord derived Mesenchymal Stem Cells (UC-MSC) for treatment of COVID-19 Patients with Severe Complications of Acute Lung Injury/Acute Respiratory Distress Syndrome (ALI/ARDS).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection, ARDS, ARDS, Human, Acute Respiratory Distress Syndrome, COVID-19
Keywords
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
The trial has two groups, each with 12 subjects (n=24). All eligible subjects will be randomized to either the treatment group or standard of care, and randomization will be stratified by ARDS severity.
Masking
ParticipantCare ProviderInvestigator
Masking Description
Double-Blinding Trial
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
UC-MSCs Group
Arm Type
Experimental
Arm Description
Participants in this group will be treated with two infusions of UC-MCSs along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
Participants in this group will be treated with two infusions of vehicle along with heparin (blood thinner) in addition to standard of care treatment. The first infusion will be administered within 24 hours of study enrollment and the second infusion will be administered within 72 hours of study enrollment.
Intervention Type
Biological
Intervention Name(s)
Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.
Intervention Description
UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.
Intervention Type
Other
Intervention Name(s)
Vehicle + Heparin along with best supportive care
Intervention Description
Best supportive care treatment per the treating hospital protocol.
Primary Outcome Measure Information:
Title
Number of Participants With Pre-Specified Infusion Associated Adverse Events
Description
Safety as defined by the number of pre-specified infusion associated adverse events as assessed by treating physician. Any of the following occurring within 6 h post each infusion:
An increase in vasopressor dose greater than or equal to the following:
Norepinephrine: 10 μg/min
Phenylephrine: 100 μg/min
Dopamine: 10 μg/kg/min
Epinephrine: 10 μg/min
In patients receiving mechanical ventilation: worsening hypoxemia, as assessed by a requirement for an increase of PEEP by 5 cm H2O over baseline, or requirement to increase FiO2 of >20%.
In patients receiving high flow oxygen therapy: worsening hypoxemia, as indicated by requirement of intubation and mechanical ventilation.
New cardiac arrhythmia requiring cardioversion
New ventricular tachycardia, ventricular fibrillation, or asystole
A clinical scenario consistent with transfusion incompatibility or transfusion-related infection
Cardiac arrest or death within 24h post infusion
Time Frame
6 and 24 hours
Title
Number of Subjects With Serious Adverse Events by 31 Days After First Infusion
Description
The number of subjects experiencing serious adverse events by 31 days after the first infusion (corresponding to 28 days after the last infusion).
Time Frame
31 days
Title
Percentage of Participants Experiencing Serious Adverse Events (SAEs) Through Study Day 90
Description
Safety will be reported as the percentage of participants experiencing serious adverse events through Day 90 as assessed by treating physician.
Time Frame
90 days
Title
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Total number of adverse events and serious adverse events as assessed by treating physician
Time Frame
90 days
Title
Number of Adverse Events (AEs) and Serious Adverse Events (SAEs) by Severity
Description
Total number of adverse events plus serious adverse events categorized by severity.
Time Frame
90 days
Title
Subjects With Adverse Events and Serious Adverse Events by Severity
Description
Total number of subjects with adverse events and serious adverse events categorized by severity.
Time Frame
90 days
Title
Number of Adverse Events and Serious Adverse Events by Relatedness to Treatment
Description
Total number of adverse events and serious adverse events categorized by relatedness to treatment defined by a medical professional.
Time Frame
90 days
Title
Subjects With Adverse Events by Relatedness to Treatment
Description
Total number of subjects with adverse events categorized by relatedness to treatment by a medical professional
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Survival at 31 Days Post First Infusion
Description
Number of participants that are alive at 31 days post first infusion follow up corresponding to 28 day post second infusion.
Time Frame
31 Days
Title
Survival at 60 Days Post First Infusion
Description
Number of participants alive at 60 days post first infusion follow up.
Time Frame
60 days
Title
Time to Recovery
Description
Time to discharge or, if the subject was hospitalized, no longer requiring supplemental oxygen and no longer requiring COVID-19-related medical care by 31 days. The numbers represent days at which 25%, 50%, 75% subjects within the treatment group had recovered.
Time Frame
31 days
Title
Ventilator-Free Days Throughout 28 Days Post Second Infusion
Description
Number of days participants were off ventilators during 28 days post second infusion.
Time Frame
28 days post second infusion
Title
Ventilator-Free Days Throughout 90 Days
Description
Number of days participants were off ventilators within up to 90 days of hospitalization.
Time Frame
90 days or hospital discharge, whichever is earlier
Title
Respiratory Rate and Oxygenation Index (ROX Index)
Description
Respiratory Rate-Oxygenation (ROX) index is defined as the ratio of oxygen saturation as measured by pulse oximetry (SpO2)/ Fraction of inspired oxygen (FiO2) to respiratory rate. This index can be used in the assessment of disease progression and the risk of intubation in COVID-19 patients with pneumonia.
Time Frame
day 6
Title
Oxygenation Index (OI)
Description
Measure of the fraction of inspired oxygen (FiO2) and its usage within the body during intensive care, measured using fNIRS (Functional Near Infrared Spectroscopy). The calculation for Oxygenation index is ((FIO2 * Mean airway pressure)/partial pressure of oxygen).
Time Frame
day 6
Title
Positive End-Expiratory Pressure (PEEP) and Plateau Pressure (Pplat)
Description
Measuring the respiratory mechanics; positive end-expiratory pressure (PEEP) and plateau pressure (Pplat) in ventilated patients visit 8 (day 6)
Time Frame
day 6
Title
Sequential Organ Failure Assessment (SOFA) Scores
Description
Sequential Organ Failure Assessment (SOFA) Scores is used to track a person's risk status during stay in the Intensive Care Unit (ICU). The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal, and neurological systems. Each organ system is assigned a point value from a minimum of 0 (normal) to a maximum of 4 (high degree of dysfunction/failure). The total score corresponds to the sum of the six different scores of the organ systems. In total, the minimum SOFA score is 0 (normal) and the maximum SOFA score is 24 (highest degree dysfunction/failure).
Time Frame
Day 6
Title
Smell Identification Test (SIT) Scores
Description
SIT measures the participant's sense of smell. SIT has a total score ranging from 0 to 40 with the higher the score indicating a more normal sense of smell
Time Frame
90 days
Title
White Blood Cell Count (WBC)
Description
As assessed via serum blood samples.
Time Frame
day 6
Title
Platelets Count
Description
As assessed via serum blood samples.
Time Frame
day 6
Title
Hemogoblin
Description
Measures the total amount of the oxygen-carrying protein in the blood as assessed via serum blood samples.
Time Frame
day 6
Title
Hematocrit
Description
The percentage by volume of red cells in your blood as assessed via serum blood samples.
Time Frame
day 6
Title
Neutrophils
Description
the amount of immune cells (that is one of the first cell types to travel to the site of an infection) as assessed via serum blood samples
Time Frame
day 6
Title
Lymphocytes
Description
Lymphocyte count as assessed via serum blood samples
Time Frame
day 6
Title
Glomerular Filtration Rate
Description
Glomerular filtration rate (GFR) as assessed via serum blood samples to check how well the kidneys are working. It estimates how much blood passes through the glomeruli each minute.
Time Frame
day 6
Title
Total Protein
Description
Total protein as assessed via serum blood samples as a part of the comprehensive metabolic panel (CMP). It is a measurement of the sum of albumin and globulins.
Time Frame
Day 6
Title
Sodium
Description
Sodium levels as assessed by serum blood samples.
Time Frame
day 6
Title
Potassium
Description
Potassium levels as assessed via serum blood samples.
Time Frame
day 6
Title
Creatinine
Description
Creatinine levels as assessed via serum blood samples
Time Frame
day 6
Title
Glucose
Description
Glucose levels as assessed via serum blood samples
Time Frame
day 6
Title
Albumin
Description
Albumin levels as assessed via serum blood samples
Time Frame
day 6
Title
Alkaline Phosphatase
Description
Alkaline phosphatase levels as assessed via serum blood samples for the Comprehensive Metabolic Panel.
Time Frame
day 6
Title
Alanine Aminotransferase or Serum Glutamate-pyruvate Transaminase (ALT or SGPT)
Description
The alanine aminotransferase or serum glutamate-pyruvate transaminase (ALT or SGPT) test as assessed via serum blood samples
Time Frame
day 6
Title
Aspartate Aminotransferase or Serum Glutamic Oxaloacetic Transaminase (AST or SGOT)
Description
The aspartate aminotransferase or serum glutamic oxaloacetic transaminase (AST or SGOT) test as assessed via serum blood samples
Time Frame
day 6
Title
Total Bilirubin
Description
Bilirubin levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame
day 6
Title
Blood Urea Nitrogen (BUN)
Description
Blood urea nitrogen (BUN) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame
day 6
Title
Calcium
Description
Calcium levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame
day 6
Title
Chloride
Description
Chloride levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame
day 6
Title
Carbon Dioxide (CO2)
Description
Carbon Dioxide (CO2) levels as assessed via serum blood samples for the comprehensive metabolic panel.
Time Frame
day 6
Title
C-Reactive Protein Levels
Description
As assessed via serum blood samples.
Time Frame
day 6
Title
Arachidonic Acid/Eicosapentaenoic Acid (AA/EPA) Ratio
Description
As assessed via serum blood samples on day 6 (visit 8).
Time Frame
day 6
Title
D-dimer Levels
Description
As assessed via serum blood samples.
Time Frame
day 6
Title
25-Hydroxy Vitamin D Levels
Description
As assessed via serum blood samples.
Time Frame
day 6
Title
Tumor Necrosis Factor-alpha (TNFα)
Description
Analysis of TNFα in peripheral blood plasma
Time Frame
day 6
Title
Tumor Necrosis Factor-beta (TNFβ)
Description
Analysis of TNFβ in peripheral blood plasma
Time Frame
day 6
Title
Soluble Tumor Necrosis Factor Receptor 2 (sTNFR2)
Description
Analysis of soluble tumor necrosis factor receptor 2 (sTNFR2) in peripheral blood plasma
Time Frame
day 6
Title
Viral Load by SARS-CoV-2 RT-PCR
Description
Viral load as assessed in blood plasma for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) via Reverse Transcriptase Polymerase Chain Reaction (RT-PCR).
Time Frame
day 6
Title
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 3 Post First Infusion
Description
Number of participants reporting panel reactive antibody (PRA) positivity at Day 3 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame
day 3 post first infusion
Title
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 6 Post First Infusion
Description
Number of participants reporting panel reactive antibody (PRA) positivity at Day 6 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame
day 6
Title
Number of Participants Reporting Panel Reactive Antibody (PRA) Positivity at Day 14 Post First Infusion
Description
Number of participants reporting panel reactive antibody (PRA) positivity at Day 14 post first infusion for class I and class II as assessed via serum blood samples. These antibodies can develop following a transplant. Recipients can become sensitized to certain molecules (Human Leukocyte Antigen Class I or Class II), which can affect immune responses to and rejection of potential future transplants.
Time Frame
day 14
Title
Number of Participants With Positive, Negative, or Borderline Serology Testing for SARS-CoV-2 IgM/IgG
Description
Number of participants with positive, negative, or borderline SARS-CoV-2 Immunoglobulin M (IgM)/Immunoglobulin G (IgG) serology from serum blood samples.
Time Frame
day 14 post first infusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients >/= 18 years old diagnosed with COVID-19 (as evaluated by PCR test confirming infection with SARS-CoV-2) will be eligible for inclusion if they meet all of the below criteria. Inclusion criteria must all be present within a 24-hour time period at the time of enrollment:
Patient currently hospitalized
Aged ≥ 18 years
Willing and able to provide written informed consent, or with a legal representative who can provide informed consent
Peripheral capillary oxygen saturation (SpO2) ≤ 94% at room air, or requiring supplemental oxygen at screening
PaO2/FiO2 ratio < 300 mmHg
Bilateral infiltrates on frontal chest radiograph or bilateral ground glass opacities on a chest CT scan
Hypoxemia requiring an increase in the fraction of inspired oxygen (FiO2) of ≥ 20% AND an increase in positive end-expiratory airway pressure (PEEP) level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%, or requirement for escalation from oxygen therapy to invasive mechanical ventilation
Exclusion Criteria:
PaO2/FiO2 ≥ 300 at the time of enrollment
A previous MSC infusion not related to this trial
History of Pulmonary Hypertension (WHO Class III/IV)
History of left atrial hypertension or decompensated left heart failure.
Pregnant or lactating patient
Unstable arrhythmia
Patients with previous lung transplant
Patients currently receiving chronic dialysis
Patients currently receiving Extracorporeal Membrane Oxygenation (ECMO)
Presence of any active malignancy (except non-melanoma skin cancer)
Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
Moderate to severe liver disease (AST and ALT >5 X ULN)
Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
Baseline QT prolongation
Moribund patient not expected to survive > 24 hours
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camillo Ricordi, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diabetes Research Institute, University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of UC-MSCs for COVID-19 Patients
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